Note: This document contains side effect information about zolmitriptan. Some dosage forms listed on this page may not apply to the brand name Zomig.

Summary

Common side effects of Zomig include: dysgeusia. Other side effects include: dizziness, drowsiness, hyperesthesia, jaw pain, nausea, neck pain, paresthesia, sore throat, flushing sensation, local pain, and sensation of cold. Continue reading for a comprehensive list of adverse effects.

Applies to zolmitriptan: oral tablet, oral tablet disintegrating. Other dosage forms:

• nasal spray

Serious side effects of Zomig

Along with its needed effects, zolmitriptan (the active ingredient contained in Zomig) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zolmitriptan:

More common

• Chest pain (severe)
• heaviness, tightness, or pressure in the chest or neck
• sensation of burning, warmth, heat, numbness, tightness, or tingling

Less common or rare

• Abdominal or stomach pain (severe)
• changes in facial skin color
• cough or hoarseness
• diarrhea
• fast or irregular heartbeat
• fever or chills
• hives, itching, or skin rash
• itching
• loss of appetite
• lower back or side pain
• nausea
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, or lips
• tightness in the chest
• trouble breathing
• weakness

Rare

• Blurred vision
• confusion
• difficulty swallowing
• dizziness
• fainting
• frequent strong or increased urge to urinate
• headache
• increased volume of pale, dilute urine
• nervousness
• pounding in the ears
• severe numbness, especially on one side of the face or body
• slow heartbeat
• unusual tiredness or weakness

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects of Zomig

Some side effects of zolmitriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Lack or loss of strength
• sleepiness or unusual drowsiness
• warm or cold sensation

Less common

• Dizziness or lightheadedness
• dry mouth
• feeling of constant movement of self or surroundings
• sensation of spinning

Rare

• Anxiety
• crying
• depersonalization
• depression
• dysphoria
• euphoria
• hyperventilation
• irritability
• loss of memory
• paranoia
• problems with memory
• quick to react or overreact emotionally
• rapidly changing moods
• redness of the skin
• seeing, hearing, or feeling things that are not there
• shaking
• trouble sleeping
• welts

For Healthcare Professionals

Applies to zolmitriptan: nasal spray, oral tablet, oral tablet disintegrating.

Cardiovascular

Rare reports of serious cardiac adverse events have been reported including acute myocardial infarction within a few hours following administration of this drug.

Chest pain/tightness/pressure and/or heaviness appear to be dose-related occurring in 2%, 3%, and 4% of patients receiving 1 mg, 2.5 mg, and 5 mg, respectively. Neck/throat/jaw pain/tightness/pressure occurred in 4%, 7%, and 10% of patients, respectively.^[Ref]

Common (1% to 10%): Chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, palpitations

Uncommon (0.1% to 1%): Arrhythmias, hypertension, syncope, tachycardia

Rare (less than 0.1%): Angina pectoris, myocardial infarct, coronary vasospasm, QT prolongation, thrombophlebitis^[Ref]

Nervous system

Very Common (greater than 10%): Taste disturbances (up to 21%, inhaler)

Common (1% to 10%): Paresthesia, somnolence, dizziness, hyperesthesia

Rare (less than 0.1%): Cerebral ischemia, amnesia, convulsions, ataxia, dystonia, hyperkinesia, hypotonia, hypertonia

Frequency not reported: Serotonin syndrome^[Ref]

Paresthesia appears to be a dose-related adverse event occurring in 5%, 7%, and 9% of patients receiving 1 mg, 2.5 mg, and 5 mg, respectively.^[Ref]

Other

Common (1% to 10%): Warm/cold sensation, heaviness other than chest or neck, pressure/tightness/heaviness, vertigo, asthenia, chills

Uncommon (0.1% to 1%): Tinnitus, hyperacusis, ear pain^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dry mouth, dysphagia, dyspepsia, abdominal pain, vomiting

Uncommon (0.1% to 1%): Gastroenteritis, increased thirst

Rare (less than 0.1%): Stomatitis, constipation, hematemesis, pancreatitis, melena, ulcer

Very rare (less than 0.01%): Bloody diarrhea, gastrointestinal infarction or necrosis, gastrointestinal ischemic events, ischemic colitis, splenic infarction^[Ref]

General

The most common adverse reactions included neck, throat, jaw pain; dizziness; paresthesia; asthenia; somnolence; warm and cold sensation; nausea; heaviness sensation; and dry mouth. In adolescents treated with the nasal spray, the more commonly reported adverse reactions included dysgeusia, nasal discomfort, dizziness, oropharyngeal pain, and nausea.^[Ref]

Hematologic

Uncommon (0.1% to 1%): ecchymosis

Rare (less than 0.1%): Thrombocytopenia, eosinophilia, leucopenia^[Ref]

Metabolic

Uncommon (0.1% to 1%): Increased appetite, thirst

Rare (less than 0.1%): Anorexia, hyperglycemia^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, muscle weakness

Uncommon (0.1% to 1%): Back pain, leg cramps, tenosynovitis

Rare (less than 0.1%): Arthritis, tetanus, twitching^[Ref]

Respiratory

Common (1% to 10%): Disorder/discomfort of nasal cavity, throat pain, throat tightness, oropharyngeal pain

Uncommon (0.1% to 1%): Pharyngitis, rhinitis, dyspnea, sinusitis, bronchitis, increased cough, epistaxis, laryngeal edema, hiccup, laryngitis, yawn

Rare (less than 0.1%): Apnea, voice alteration^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions

Postmarketing reports: Hypersensitivity reactions including angioedema, anaphylactic reactions and anaphylactic shock^[Ref]

Ocular

Rare (less than 0.1%): Diplopia, dry eyes, lacrimation, conjunctivitis, eye pain, visual field defect^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Polyuria, urinary urgency, cystitis, hematuria

Rare (less than 0.1%): Urinary frequency, miscarriage, dysmenorrhea^[Ref]

Dermatologic

Common (1% to 10%): Sweating, facial edema

Uncommon (0.1% to 1%): Urticaria, pruritus, rash, photosensitivity reaction

Rare (less than 0.1%): Angioedema^[Ref]

Local

Common (1% to 10%): Local irritation or soreness at the site of administration of nasal spray

In clinical trials using the nasal spray approximately 3% (n=460) patients reported local irritation or soreness at the site of administration. Effects were severe in about 1% of patients and approximately 57% resolved in 1 hour. Nasopharyngeal examinations of a subset of patients failed to demonstrate any clinically significant changes with repeated use of the nasal spray.