LABELS · ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

dantrolene sodium

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: 2026-08-21
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

Dantrolene sodium has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to dantrolene sodium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to dantrolene sodium . Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium . However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Indications and usage: exact source text

INDICATIONS AND USAGE In Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful and/or disabling spasticity such as clonus, or permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of any annoying manifestation of spasticity considered important by the patient himself. In Malignant Hyperthermia: Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous. Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.

Full extracted label fields

application numbers

NDA017443

boxed warning exact

Dantrolene sodium has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to dantrolene sodium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to dantrolene sodium . Spontaneous reports suggest a higher proportion of hepatic events with fatal outcome in elderly patients receiving dantrolene sodium . However, the majority of these cases were complicated with confounding factors such as intercurrent illnesses and/or concomitant potentially hepatotoxic medications (see Geriatric Use subsection). Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT. If no observable benefit is derived from the administration of dantrolene sodium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

brand names

dantrolene sodium

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=11689f56-15e0-4350-b53f-ae96e5994fea

generic names

DANTROLENE SODIUM

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

indications and usage exact

INDICATIONS AND USAGE In Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful and/or disabling spasticity such as clonus, or permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of any annoying manifestation of spasticity considered important by the patient himself. In Malignant Hyperthermia: Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous. Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.

indications and usage tables exact

is original packager

true

manufacturer names

Par Health USA, LLC

matched search terms

malignant

package ndcs

49884-362-01
49884-363-01
49884-364-01

product ndcs

49884-362
49884-363
49884-364

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

856652
856656
856660

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.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

NDA017443

brand names

dantrolene sodium

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: 451
end exclusive: true
exact text: INDICATIONS AND USAGE In Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of sp
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 0

current approval status

not_reconciled

duplicate text group

dup-38092916a7e01e66e9c0

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-d7a4ddd6b8b4ab728579

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

end: 75
end exclusive: true
exact text: is indicated
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 63

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 251
end exclusive: true
exact text: INDICATIONS AND USAGE In Chronic Spasticity: Dantrolene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis).
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 575
end exclusive: true
exact text: ene sodium is indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is not indicated in the treatment of skeletal muscle spa
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 52

current approval status

not_reconciled

duplicate text group

dup-66e97150fe36c4b1f590

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-93491c2c5b430641c15e

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

context exact
fit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity.
kind
biomarker
polarity
not_inferred
span
end
374
end exclusive
true
exact text
retarded by the sequelae of spasticity
label id
ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start
336

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 375
end exclusive: true
exact text: It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 252

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 3 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 700
end exclusive: true
exact text: (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAG
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 176

current approval status

not_reconciled

duplicate text group

dup-14cc5381c1ea1bb3c2f4

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-04495dda7e38355c5a5a

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 500
end exclusive: true
exact text: Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 376

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 · limitation of use

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 813
end exclusive: true
exact text: functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to res
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 301

current approval status

not_reconciled

duplicate text group

dup-3e2fcad08c858aee8959

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-5035c2a3c9aa9ec97bcd

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 613
end exclusive: true
exact text: Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 501

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 5 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1081
end exclusive: true
exact text: ersible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and t
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 414

current approval status

not_reconciled

duplicate text group

dup-8ab57e52b1d7eb384a55

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-50cb20e50fe71e7312e8

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 881
end exclusive: true
exact text: If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 614

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 6 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1185
end exclusive: true
exact text: tration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium fo
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 682

current approval status

not_reconciled

duplicate text group

dup-b02c99534d913f3f5b25

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-752a999b8ab419aa7839

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 985
end exclusive: true
exact text: Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 882

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1344
end exclusive: true
exact text: city and the ability to resume a daily function not quite attainable without dantrolene sodium. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decisi
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 786

current approval status

not_reconciled

duplicate text group

dup-852d2dcb5d899b23cf5b

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-8b455a9d5199643c7503

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1144
end exclusive: true
exact text: In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 986

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1535
end exclusive: true
exact text: ay occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful an
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 945

current approval status

not_reconciled

duplicate text group

dup-0113d141ae7642e488dd

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-6a311f2f19e110894633

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1335
end exclusive: true
exact text: Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1145

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 9 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1977
end exclusive: true
exact text: ith him. Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful and/or disabling spasticity such as clonus, or permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of any annoying manifestation of spasticity considered important by the patient himself. In Malignant Hyperthermia: Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1136

current approval status

not_reconciled

duplicate text group

dup-dc9aa455e1d82c7b01a9

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-08e33ff11597abb3a715

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 1777
end exclusive: true
exact text: A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen: produces a significant reduction in painful and/or disabling spasticity such as clonus, or permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1336

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 · positive indication candidate

application numbers

NDA017443

brand names

dantrolene sodium

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: 2249
end exclusive: true
exact text: r permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of any annoying manifestation of spasticity considered important by the patient himself. In Malignant Hyperthermia: Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mech
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1578

current approval status

not_reconciled

duplicate text group

dup-6caa4ff2b543fa56266d

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-dc044716b7945bfd6630

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

end: 1845
end exclusive: true
exact text: is also indicated
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1828

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 2049
end exclusive: true
exact text: In Malignant Hyperthermia: Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1778

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 11 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2611
end exclusive: true
exact text: peratively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous. Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 1850

current approval status

not_reconciled

duplicate text group

dup-536eb72b1826302635c8

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-092c58b7278db01462cf

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 2461
end exclusive: true
exact text: Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 2050

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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 12 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2611
end exclusive: true
exact text: ompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous. Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 2262

current approval status

not_reconciled

duplicate text group

dup-de8de66f3bc85557f20c

extraction review status

automated_candidate_pending_source_review

generic names

DANTROLENE SODIUM

ind-span-2db4becb66852bf78a3b

label id

ce31d4e7-88a5-4eca-a20e-c03e31d2b88b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

source span

end: 2611
end exclusive: true
exact text: Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
label id: ce31d4e7-88a5-4eca-a20e-c03e31d2b88b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c1c31e544ed81c28a25e863a0d4c61a47eb8b23c044cccb7fcc0c16bdad57b40
start: 2462

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ce31d4e7-88a5-4eca-a20e-c03e31d2b88b%22

spl effective date

2026-08-21

spl set id

11689f56-15e0-4350-b53f-ae96e5994fea

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