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 Chlorzoxazone containing products are usually well tolerated.
It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding.
Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient.
Rarely, allergic type skin rashes, petechiae, or ecchymoses may develop during treatment.
Angioneurotic edema or anaphylactic reactions are extremely rare.
There is no evidence that the drug will cause renal damage.
Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone.
This finding is of no known clinical significance.
To report SUSPECTED ADVERSE EVENTS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
WARNINGS Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone.
The mechanism is unknown but appears to be idiosyncratic and unpredictable.
Factors predisposing patients to this rare event are not known.
Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice.
Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop.
Like all medications, Chlorzoxazone 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: