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 Most adverse reactions occurring during therapy with cycloserine involve the nervous system or are manifestations of drug hypersensitivity.
The following side effects have been observed in patients receiving cycloserine: Nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) • Convulsions • Drowsiness and somnolence • Headache • Tremor • Dysarthria • Vertigo • Confusion and disorientation with loss of memory • Psychoses, possibly with suicidal tendencies • Character changes • Hyperirritability • Aggression • Paresis • Hyperreflexia • Paresthesia • Major & minor (localized) clonic seizures • Coma Cardiovascular: Sudden development of congestive heart failure in patients receiving 1 to 1.5 g of cycloserine daily has been reported.
Allergy (apparently not related to dosage) Skin rash Miscellaneous: Elevated serum transaminase, especially in patients with preexisting liver disease To report SUSPECTED ADVERSE REACTIONS, contact Cerovene, Inc.
at 1-833-304-9569 or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS Administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of CNS toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo paresis, or dysarthria.
The toxicity of cycloserine is closely related to excessive blood levels (above 30 mcg/mL), as determined by high dosage or inadequate renal clearance.
The ratio of toxic dose to effective dose in tuberculosis is small.
The risk of convulsions is increased in chronic alcoholics.
Patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.
Like all medications, Cycloserine 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: