Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The most frequently occurring side effects of dantrolene sodium 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 dantrolene sodium therapy.
If diarrhea recurs upon readministration of dantrolene sodium , therapy should probably be withdrawn permanently.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 (see WARNINGS ).
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.
WARNINGS It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.
At the start of dantrolene sodium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease.
If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for dantrolene sodium hepatotoxicity could be enhanced, although such a possibility has not yet been established.
Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during dantrolene sodium therapy.
If such studies reveal abnormal values, therapy should generally be discontinued.
Like all medications, Dantrolene Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: