LABELS · 5039fd42-8304-4d69-e063-6294a90ab004

dantrolene sodium

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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: 2026-04-24
Captured: 2026-09-09T23:37:47.659725+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=c10e7eb1-0155-43ff-aa56-8cd468e8e84d

generic names

DANTROLENE SODIUM

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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

manufacturer names

REMEDYREPACK INC.

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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
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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
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start: 986

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Passage 8 · unclassified context

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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
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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.
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use intent

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Passage 9 · unclassified context

application numbers

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brand names

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no_unambiguous_positive_indication_predicate

clinical review status

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content role

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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
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end: 1777
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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.
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start: 1336

source url

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spl effective date

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use intent

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Passage 10 · positive indication candidate

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

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clinical review status

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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
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exact text: is also indicated
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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.
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start: 1778

source url

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use intent

non_oncology_or_unclear_candidate

Passage 11 · unclassified context

application numbers

NDA017443

brand names

dantrolene sodium

classification reasons

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clinical review status

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content role

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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.
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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.
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start: 2050

source url

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spl effective date

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line: Source null
prior therapy: Source null
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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

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content role

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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.
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positive predicate support span

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qualifier mentions

regulatory links

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end: 2611
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exact text: Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
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start: 2462

source url

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use intent

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Preserved source evidence · Not medical advice