Dantrium Side Effects

Generic Name: dantrolene

Please note - some side effects for Dantrium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dantrium - for the Consumer

Dantrium

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dantrium:

Decreased grip strength; diarrhea; dizziness; drowsiness; general body discomfort; lightheadedness; muscle weakness; nausea; pain or redness at injection site; unusual tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood vessel inflammation; chest pain; dark urine; difficulty swallowing; inflammation at the injection site; severe stomach or abdominal pain; shallow breathing; unusual tiredness; yellowing of skin or eyes.

Dantrium Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dantrium Capsules:

Diarrhea; dizziness; drowsiness; general body discomfort; nausea; sensitivity to sunlight; unusual tiredness; vision changes; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; chest pain; coffee ground-like vomit; confusion; dark urine; depression; difficulty urinating; fast heartbeat; fever or chills; seizures; severe or persistent diarrhea; severe stomach or abdominal pain; shortness of breath; unusual tiredness; vomiting; yellowing of the skin or eyes.

Dantrium Side Effects - for the Professional

Dantrium

The most frequently occurring side effects of Dantrium have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of Dantrium therapy. If diarrhea recurs upon readministration of Dantrium, therapy should probably be withdrawn permanently.

Other less frequent side effects, listed according to system, are:

Gastrointestinal: Constipation, rarely progressing to signs of intestinal obstruction, GI bleeding, anorexia, swallowing difficulty, gastric irritation, abdominal cramps, nausea and/or vomiting.

Hepatobiliary: Hepatitis.

Neurologic: Speech disturbance, seizure, headache, light-headedness, visual disturbance, diplopia, alteration of taste, insomnia, drooling.

Cardiovascular: Tachycardia, erratic blood pressure, phlebitis, heart failure.

Hematologic: Aplastic anemia, anemia, leukopenia, lymphocytic lymphoma, thrombocytopenia.

Psychiatric: Mental depression, mental confusion, increased nervousness.

Urogenital: Increased urinary frequency, crystalluria, hematuria, difficult erection, urinary incontinence and/or nocturia, difficult urination and/or urinary retention.

Integumentary: Abnormal hair growth, acne-like rash, pruritus, urticaria, eczematoid eruption, sweating.

Musculoskeletal: Myalgia, backache.

Respiratory: Feeling of suffocation, respiratory depression.

Special Senses: Excessive tearing.

Hypersensitivity: Pleural effusion with pericarditis, anaphylaxis.

Other: Chills and fever.

The published literature has included some reports of Dantrium use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrium capsules are not indicated for the treatment of NMS and patients may expire despite treatment with Dantrium capsules.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Side Effects by Body System

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. 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.

Local

Local side effects have included thrombophlebitis in patients receiving intravenous dantrolene.

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 treatment.

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