home > drugs a-z list > zomig (zolmitriptan) drug center > zomig (zolmitriptan) drug - side effects and drug interactions

Serious cardiac events, including myocardial infarction, have occurred following the use of ZOMIG (zolmitriptan) Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported, in association with drugs of this class, have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).

Incidence in Controlled Clinical Trials

Among 2,633 patients treated with ZOMIG (zolmitriptan) Tablets in the active and placebo controlled trials, no patients withdrew for reasons related to adverse events, but as patients treated a single headache in these trials, the opportunity for discontinuation was limited. In a long-term, open label study where patients were allowed to treat multiple migraine attacks for up to 1 year, 8% (167 out of 2,058) withdrew from the trial because of adverse experience. The most common events were paresthesia, asthenia, nausea, dizziness, pain, chest or neck tightness or heaviness, somnolence and warm sensation.

Table 2 lists the adverse events that occurred in ≥ 2% of the 2,074 patients in any one of the ZOMIG (zolmitriptan) 1 mg, ZOMIG (zolmitriptan) 2.5 mg or ZOMIG (zolmitriptan) 5 mg Tablets dose groups of the controlled clinical trials. Only events that were more frequent in a ZOMIG (zolmitriptan) Tablets group compared to the placebo groups are included. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Several of the adverse events appear dose related, notably paresthesia, sensation of heaviness or tightness in chest, neck, jaw, and throat, dizziness, somnolence and possibly asthenia and nausea.

Table 2: Adverse Experience Incidence in Five Placebo-Controlled Migraine Clinical Trials: Events Reported By ≥ 2% Patients Treated With ZOMIG (zolmitriptan) Tablets

ZOMIG (zolmitriptan) is generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse events.

Other Events

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of ZOMIG (zolmitriptan) in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used ZOMIG (zolmitriptan) Tablets (n=4,027) and reported an event divided by the total number of patients exposed to ZOMIG (zolmitriptan) Tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare adverse events are those occurring in fewer than 1/1,000 patients.

Atypical sensation: Infrequent was hyperesthesia.

General: Infrequent were allergy reaction, chills, facial edema, fever, malaise and photosensitivity.

Cardiovascular: Infrequent were arrhythmias, hypertension, and syncope. Rare were bradycardia, extrasystoles, postural hypotension, QT prolongation, tachycardia and thrombophlebitis.

Digestive: Infrequent were increased appetite, tongue edema, esophagitis, gastroenteritis, liver function abnormality and thirst. Rare were anorexia, constipation, gastritis, hematemesis, pancreatitis, melena, and ulcer.

Hemic: Infrequent was ecchymosis. Rare were cyanosis, thrombocytopenia, eosinophilia and leukopenia.

Metabolic: Infrequent was edema. Rare were hyperglycemia and alkaline phosphatase increased.

Musculoskeletal: Infrequent were back pain, leg cramps and tenosynovitis. Rare were arthritis, asthenia, tetany and twitching.

Neurological: Infrequent were agitation, anxiety, depression, emotional lability and insomnia; Rare were akathisia, amnesia, apathy, ataxia, dystonia, euphoria, hallucinations, cerebral ischemia, hyperkinesia, hypotonia, hypertonia and irritability.

Respiratory: Infrequent were bronchitis, bronchospasm, epistaxis, hiccup, laryngitis, and yawn. Rare were apnea and voice alteration.

Skin: Infrequent were pruritus, rash and urticaria.

Special Senses: Infrequent were dry eye, eye pain, hyperacusis, ear pain, parosmia, and tinnitus. Rare were diplopia and lacrimation.

Urogenital: Infrequent were hematuria, cystitis, polyuria, urinary frequency, urinary urgency. Rare were miscarriage and dysmenorrhea.

The adverse experiences profile seen with ZOMIG (zolmitriptan) -ZMT Tablets was similar to that seen with ZOMIG (zolmitriptan) Tablets.

Postmarketing Experience with ZOMIG (zolmitriptan) Tablets

The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and non-domestic use of oral zolmitriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of zolmitriptan in their causation cannot be reliably determined.

Cardiovascular

Coronary artery vasospasm; transient myocardial ischemia, angina pectoris, and myocardial infarction.

Digestive

Very rare gastrointestinal ischemic events including splenic infarction, ischemic colitis and gastrointestinal infarction or necrosis have been reported; these may present as bloody diarrhea or abdominal pain. (See WARNINGS.)

Neurological

As with other acute migraine treatments including other 5-HT₁ agonists, there have been rare reports of headache.

General

As with other 5-HT_1B/1D agonists, there have been very rare reports of anaphylaxis or anaphylactoid reactions in patients receiving ZOMIG (zolmitriptan) . There have been rare reports of hypersensitivity reactions, including angioedema.

Serotonin syndrome has also been reported during the postmarketing period (see WARNINGS and PRECAUTIONS).

Drug Abuse And Dependence

The abuse potential of ZOMIG (zolmitriptan) has not been assessed in clinical trials.

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because there is a theoretical basis that these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and zolmitriptan within 24 hours of each other should be avoided (see CONTRAINDICATIONS).

MAO-A inhibitors increase the systemic exposure of zolmitriptan. Therefore, the use of zolmitriptan in patients receiving MAO-A inhibitors is contraindicated (see CLINICAL PHARMACOLOGY and CONTRAINDICATIONS).

Concomitant use of other 5-HT1B/1D agonists within 24 hours of ZOMIG (zolmitriptan) treatment is not recommended. (see CONTRAINDICATIONS).

Following administration of cimetidine, the half-life and AUC of zolmitriptan and its active metabolites were approximately doubled (see CLINICAL PHARMACOLOGY).

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome: Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans (See WARNINGS).

Drug/Laboratory Test Interactions

Zolmitriptan is not known to interfere with commonly employed clinical laboratory tests.

Last reviewed on RxList: 9/7/2010
This monograph has been modified to include the generic and brand name in many instances.