LABELS · 5411f81a-2433-5acf-e063-6294a90a838c

Bromocriptine Mesylate

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-06-12
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS & USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested. Parkinson’s Disease Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure” on levodopa therapy. Bromocriptine mesylate therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off” phenomenon). Continued efficacy of bromocriptine mesylate therapy during treatment of more than 2 years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson’s disease with bromocriptine mesylate. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate therapy.

Full extracted label fields

application numbers

NDA017962

boxed warning exact

brand names

Bromocriptine Mesylate

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ddd292a5-72af-448f-8b88-cc4fd99ec783

generic names

BROMOCRIPTINE MESYLATE

5411f81a-2433-5acf-e063-6294a90a838c

indications and usage exact

INDICATIONS & USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested. Parkinson’s Disease Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure” on levodopa therapy. Bromocriptine mesylate therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off” phenomenon). Continued efficacy of bromocriptine mesylate therapy during treatment of more than 2 years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson’s disease with bromocriptine mesylate. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate therapy.

indications and usage tables exact

is original packager

manufacturer names

American Health Packaging

matched search terms

tumor

package ndcs

60687-931-11
60687-931-21

product ndcs

60687-931

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

197411

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 447
end exclusive: true
exact text: INDICATIONS & USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reducti
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 0

current approval status

not_reconciled

duplicate text group

dup-85dd02be2cc4d06303e7

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-6f7435992de717f9453a

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

end: 98
end exclusive: true
exact text: is indicated
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 86

qualifier mentions

context exact
ons associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.
kind
regimen
polarity
not_inferred
span
end
246
end exclusive
true
exact text
with or without galactorrhea, infertility or hypogonadism
label id
5411f81a-2433-5acf-e063-6294a90a838c
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start
189

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 247
end exclusive: true
exact text: INDICATIONS & USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 2 · positive indication candidate

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 639
end exclusive: true
exact text: d Dysfunctions Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to redu
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 48

current approval status

not_reconciled

duplicate text group

dup-445d89983e42a55b1c20

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-7d99ab9716384a1a6497

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

end: 293
end exclusive: true
exact text: is indicated
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 281

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 439
end exclusive: true
exact text: Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 248

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 3 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 738
end exclusive: true
exact text: nadism. Bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate therapy is indicated in the t
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 240

current approval status

not_reconciled

duplicate text group

dup-afddc1a68d3fd33fd75b

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-ea1431e55230708fe1ad

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 538
end exclusive: true
exact text: Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 440

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 874
end exclusive: true
exact text: , which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces se
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 339

current approval status

not_reconciled

duplicate text group

dup-87a778ad0e93cb857e19

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-a93468aa9433921a9ece

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 674
end exclusive: true
exact text: In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 539

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · positive indication candidate

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 961
end exclusive: true
exact text: monstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 475

current approval status

not_reconciled

duplicate text group

dup-d2bf586e2b81da880bcb

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-830fa04cb300020cfc26

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

end: 729
end exclusive: true
exact text: is indicated
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 717

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 761
end exclusive: true
exact text: Acromegaly Bromocriptine mesylate therapy is indicated in the treatment of acromegaly.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 675

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 6 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1186
end exclusive: true
exact text: my is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation a
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 562

current approval status

not_reconciled

duplicate text group

dup-951b5d50d93fc2950ead

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-795ada320eeb123705f0

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 986
end exclusive: true
exact text: Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 762

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1400
end exclusive: true
exact text: erapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested. Parkinson’s Disease Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. As adjunctive treatment to levodopa
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 787

current approval status

not_reconciled

duplicate text group

dup-85a9e3e38121dc95b2d2

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-52c275f2fdd1c432f9ed

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1200
end exclusive: true
exact text: Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 987

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 8 · positive indication candidate

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1563
end exclusive: true
exact text: cts of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested. Parkinson’s Disease Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate therapy may provide additional therapeutic benefits in those patients who are currentl
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1001

current approval status

not_reconciled

duplicate text group

dup-2784fa70d7056d53e500

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-0f5d540414566ac3c1c4

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

end: 1265
end exclusive: true
exact text: are indicated
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1252

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1363
end exclusive: true
exact text: Parkinson’s Disease Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1201

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 9 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1961
end exclusive: true
exact text: fects of irradiation are manifested. Parkinson’s Disease Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure” on levodopa therapy. Bromocriptine mesylate therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodo
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1164

current approval status

not_reconciled

duplicate text group

dup-0c31fee94bc48d5262e6

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-c0c0eea730e5c969ea29

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1761
end exclusive: true
exact text: As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure” on levodopa therapy.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1364

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 10 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2293
end exclusive: true
exact text: ly maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure” on levodopa therapy. Bromocriptine mesylate therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off” phenomenon). Continued efficacy of bromocriptine mesylate therapy during treatment of more than 2 years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1562

current approval status

not_reconciled

duplicate text group

dup-9e4751bb3f4a0dd07057

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-ac07604dfc89133fea8c

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2093
end exclusive: true
exact text: Bromocriptine mesylate therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off” phenomenon).
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1762

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 11 · limitation of use

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 2410
end exclusive: true
exact text: d/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off” phenomenon). Continued efficacy of bromocriptine mesylate therapy during treatment of more than 2 years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson’s disease with bromocriptine mesylate. Studies have shown, however, significantly more adverse reactions (n
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 1894

current approval status

not_reconciled

duplicate text group

dup-5690fcbd411f5c8caf7e

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-19c5b47658c863d35336

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

context exact
romocriptine mesylate therapy during treatment of more than 2 years has not been established.
kind
age
polarity
not_inferred
span
end
2184
end exclusive
true
exact text
2 years
label id
5411f81a-2433-5acf-e063-6294a90a838c
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start
2177

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2210
end exclusive: true
exact text: Continued efficacy of bromocriptine mesylate therapy during treatment of more than 2 years has not been established.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2094

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 12 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2541
end exclusive: true
exact text: (e.g., dyskinesias) and the marked swings in motor function (“on-off” phenomenon). Continued efficacy of bromocriptine mesylate therapy during treatment of more than 2 years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson’s disease with bromocriptine mesylate. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-tre
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2011

current approval status

not_reconciled

duplicate text group

dup-1b76f06df8fc4336291e

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-15e9a55e60e79311ca60

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2341
end exclusive: true
exact text: Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson’s disease with bromocriptine mesylate.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2211

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 13 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2645
end exclusive: true
exact text: rapy during treatment of more than 2 years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson’s disease with bromocriptine mesylate. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate therapy.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2142

current approval status

not_reconciled

duplicate text group

dup-bf85b8aef55c885a2e20

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-6e78afeb63fe6979d664

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2555
end exclusive: true
exact text: Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-treated patients.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2342

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 14 · unclassified context

application numbers

NDA017962

brand names

Bromocriptine Mesylate

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2645
end exclusive: true
exact text: hown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate therapy.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2356

current approval status

not_reconciled

duplicate text group

dup-6b4d2e014daa494acdfa

extraction review status

automated_candidate_pending_source_review

generic names

BROMOCRIPTINE MESYLATE

ind-span-12ef08b9643ce3847c22

label id

5411f81a-2433-5acf-e063-6294a90a838c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 2645
end exclusive: true
exact text: Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate therapy.
label id: 5411f81a-2433-5acf-e063-6294a90a838c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 014a16f147ff4713f20cf2c35d39295559ed03638393f8763410dd45f4e2285d
start: 2556

source url

https://api.fda.gov/drug/label.json?search=id%3A%225411f81a-2433-5acf-e063-6294a90a838c%22

spl effective date

2026-06-12

spl set id

ddd292a5-72af-448f-8b88-cc4fd99ec783

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice