Dantrium Side Effects

Generic name: dantrolene

Note: This document contains side effect information about dantrolene. Some of the dosage forms listed on this page may not apply to the brand name Dantrium.

Some side effects of Dantrium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dantrolene: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking dantrolene (the active ingredient contained in Dantrium) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe diarrhea or constipation;

• weak or shallow breathing;

• pale skin, easy bruising or bleeding;

• trouble swallowing, especially if it causes choking;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• seizure (black-out or convulsions); or

• urinating less than usual or not at all.

Less serious side effects of dantrolene may include:

• drowsiness, dizziness, weakness, tired feeling;

• mild diarrhea or constipation;

• mild nausea, vomiting, stomach pain;

• problems with speech, balance, or walking;

• headache, confusion, vision problems;

• sleep problems (insomnia);

• sweating, drooling; or

• urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to dantrolene: intravenous powder for injection, oral capsule

Nervous system

Nervous system side effects have commonly included drowsiness (30%), dizziness (14%), and malaise. Speech disturbances, headache, seizures and hallucinations have been reported less frequently.

Gastrointestinal

Several reports of severe constipation and abdominal distention leading to functional obstruction have been reported.

Gastrointestinal side effects have frequently included diarrhea which may be severe enough to require discontinuation. Constipation, abdominal cramps, nausea, and vomiting have been reported less frequently.

Hematologic

Hematologic side effects have included aplastic anemia, leukopenia, and lymphocytic lymphoma.

Musculoskeletal

Musculoskeletal side effects have commonly included weakness which is usually tolerable. Myalgia and backache have also been reported.

Hepatic

Hepatic side effects have included hepatic injury (1.8%), hepatitis (0.6%), and fatal hepatitis (0.3%).

Risk of hepatic injury is greater in females, patients over 35 years of age, and in patients on concurrent medications. The severity of the reaction appears to increase with increases in dose and duration.

Respiratory

Respiratory side effects have infrequently included pulmonary edema with the use of intravenous dantrolene (the active ingredient contained in Dantrium) Pleural effusion and pneumonitis have also been reported.

Cardiovascular

Cardiovascular side effects have infrequently included pericarditis (both with and without pleural effusion) in patients receiving oral dantrolene (the active ingredient contained in Dantrium) Cardiovascular side effects reported postmarketing have included heart failure.

Local

Local side effects have included thrombophlebitis in patients receiving intravenous dantrolene (the active ingredient contained in Dantrium)

Dermatologic

Dermatologic side effects have included rare reports of acne.

Ocular

Ocular side effects have included visual disturbances.

Other

Other side effects have included one case of bilateral hearing loss which was thought to have been secondary to dantrolene (the active ingredient contained in Dantrium) treatment.

Hypersensitivity

Hypersensitivity side effects reported postmarketing have included anaphylaxis.

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