Zomig-ZMT Side Effects

Generic Name: zolmitriptan

Please note - some side effects for Zomig-ZMT 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 by Body System

Cardiovascular

Cardiovascular side effects including acute myocardial infarction, arrhythmias, hypertension, and syncope have been reported infrequently. Bradycardia, extrasystoles, postural hypotension, QT prolongation, tachycardia, and thrombophlebitis have rarely been reported.

Most of the serious cardiac events which have been reported occurred in patients with risk factors predicative of coronary artery disease.

In a study of patients with liver dysfunction, 7 out of 27 patients experienced 20 to 80 mm Hg elevations in systolic and/or diastolic blood pressure after a 10 mg dose of zolmitriptan.

Nervous system

Nervous system side effects (11% to 21%) including dizziness (6% to 10%), somnolence (5% to 8%), and vertigo (up to 2%) have been reported. Agitation, anxiety, depression, emotional lability, and insomnia have also been reported infrequently. Akathisia, amnesia, apathy, ataxia, dystonia, euphoria, hallucinations, cerebral ischemia, hyperkinesia, hypotonia, hypertonia, and irritability have been reported rarely. Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events including fatalities have been reported in patients treated with 5-HT1 agonists.

Regarding the cerebrovascular events reported in patients treated with 5-HT1 agonists, in a number of cases the cerebrovascular events may have been the primary event, whose symptoms were mistaken for a migraine.

Other

Other side effects including pain and pressure sensations have been reported (13% to 22%). These sensations have included chest pain/tightness/pressure and/or heaviness (2% to 4%), neck/throat/jaw pain/tightness/pressure (4% to 10%), heaviness other than the chest or neck (1% to 5%), pain from a specified location (2% to 3%), and other pressure/tightness/heaviness (2%). Atypical sensations (12% to 18%) including hypoesthesia (1% to 2%), paresthesia (5% to 9%), and warm/cold sensations (5% to 7%) have been reported. Hyperesthesia has been reported infrequently. Asthenia (3% to 9%), palpitations (up to 2%), myalgia (1% to 2%), myasthenia (up to 2%) and drug-induced headache have also been reported. Otic changes including hyperacusis, ear pain, parosmia, and tinnitus have been reported infrequently.

Gastrointestinal

Gastrointestinal ischemic events may present as bloody diarrhea or abdominal pain.

Gastrointestinal side effects (11% to 16%) including dry mouth (3% to 5%), dyspepsia (1% to 3%), dysphagia (up to 2%), and nausea (4% to 9%) have been reported. Increase in appetite, tongue edema, esophagitis, gastroenteritis, liver function abnormality, and thirst have been reported infrequently. Anorexia, constipation, gastritis, hematemesis, pancreatitis, melena, and ulcer have been reported rarely. Gastrointestinal ischemic events including splenic infarction, ischemic colitis, and gastrointestinal infarction or necrosis have been reported very rarely.

General

General side effects including allergic reactions, chills, facial edema, fever, malaise, and photosensitivity have been reported infrequently.

Several adverse effects (mostly mild and transient) are dose related, including paresthesia; sensation of heaviness or tightness in the chest, neck, jaw, and throat; dizziness; somnolence; and possibly asthenia, and nausea.

Hematologic

Hematologic side effects including ecchymosis have been reported infrequently. Cyanosis, thrombocytopenia, eosinophilia, and leukopenia have been reported rarely.

Metabolic

Metabolic side effects including edema have been reported infrequently. Hyperglycemia, and increased alkaline phosphatase have been reported rarely.

Musculoskeletal

Musculoskeletal side effects including back pain, leg cramps, and tenosynovitis have been reported infrequently. Arthritis, tetany, myalgia, and twitching have been reported rarely.

Respiratory

Respiratory side effects including bronchitis, bronchospasm, epistaxis, hiccup, laryngitis, and yawn have been reported infrequently. Apnea and voice alteration have been reported rarely.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and anaphylactoid reaction have been reported.

Ocular

Ocular side effects including dry eye and eye pain have been reported infrequently. Diplopia and lacrimation have been reported rarely.

Genitourinary

Genitourinary side effects including hematuria, cystitis, polyuria, urinary frequency, and urinary urgency have been reported infrequently. Miscarriage and dysmenorrhea have been reported rarely.

Dermatologic

Dermatologic side effects including sweating (up to 3%) have been reported. Pruritus, rash, and urticaria have been reported infrequently.

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