Side Effects of Zomig

The most common side effects reported by patients in clinical trials for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets include tingling sensation; weakness; nausea; dizziness; pain, tightness, pressure or heaviness such as in the chest, throat, neck, or jaw; drowsiness; and warm sensation.

The most common side effects reported by patients in clinical trials for Zomig Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of nasal cavity; and dry mouth.

In very rare cases, patients taking Zomig may experience serious side effects such as heart attacks, increases in blood pressure, stroke, life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body, or serious allergic reactions. In extremely rare cases, patients have died from these side effects.

Call your doctor right away if you have any of the following problems after taking Zomig:

  • Tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
  • Shortness of breath or wheezing
  • Bloody diarrhea or sudden or severe stomach pain
  • Hives or tongue, mouth, lip, or throat swelling
  • Problems seeing
  • Slurring of speech
  • Unusual weakness or numbness

Some people who take Zomig may have a reaction called serotonin syndrome, which can be life-threatening. In particular, this reaction may occur when Zomig is used together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (confusion, hallucinations, agitation, coma), fast heartbeat, changes in blood pressure, feeling faint, fever, sweating, muscle spasm, trouble walking, nausea, vomiting and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking Zomig.

This is not a complete list of side effects for Zomig. Read the full Prescribing Information and talk to your doctor if you develop any side effects.

Important Safety Information for Zomig
  • Do not take Zomig if you
    • Have heart disease or a history of heart disease
    • Have uncontrolled high blood pressure
    • Have hemiplegic or basilar migraine
    • Have or have had a stroke or symptoms of a stroke
    • Have or have had circulation (blood flow) problems
    • Have serious liver problems
    • Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications
    • Are taking monoamine oxidase (MAO) inhibitors, or if it has been less than 2 weeks since you stopped taking an MAO inhibitor
    • Are allergic to Zomig or any of its ingredients
    • Have symptomatic Wolff-Parkinson-White syndrome or other heart rhythm problems
    If you are not sure about any of the above, ask your doctor.
  • Tell your doctor about all the medicines you take or plan to take, including prescription and nonprescription medicines, supplements, and herbal remedies. Your doctor will decide if you can take Zomig with your other medicines
  • In very rare cases, patients taking Zomig may experience serious side effects such as heart attacks, increases in blood pressure, stroke, life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body, or serious allergic reactions. In extremely rare cases, patients have died from these side effects. Call your doctor right away if you have any of the following problems after taking Zomig: severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away; shortness of breath or wheezing; sudden or severe stomach pain; bloody diarrhea; hives; tongue, mouth, lip, or throat swelling; problems seeing; slurring of speech; or unusual weakness or numbness
  • Tell your doctor if you have any risk factors for heart disease such as high blood pressure, high cholesterol, diabetes, smoking, being overweight, menopause, male over age 40, or a family history of heart disease or stroke. If you have risk factors and your evaluation for heart disease is satisfactory, your doctor may ask you to take the first dose of Zomig in the doctor's office
  • Some people who take Zomig may have a reaction called serotonin syndrome which can be life-threatening. In particular this reaction may occur when Zomig is used together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (confusion, hallucinations, agitation, coma), fast heartbeat, changes in blood pressure, feeling faint, fever, sweating, muscle spasm, trouble walking, nausea, vomiting, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking Zomig
  • Phenylketonurics: Zomig-ZMT® (zolmitriptan) Orally Disintegrating Tablets contain phenylalanine, a component of the artificial sweetener aspartame
  • Tell your doctor if you are pregnant, planning to become pregnant, could be pregnant, are not using effective birth control, are breast feeding, or planning to breast feed because Zomig may not be right for you
  • The safety and effectiveness of Zomig have not been established in patients under 18 years of age or patients over 65 years of age
  • The most common side effects reported by patients in clinical trials for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets include tingling sensation; weakness; nausea; dizziness; pain, tightness, pressure or heaviness such as in the chest, throat, neck, or jaw; drowsiness; and warm sensation. The most common side effects reported by patients in clinical studies for Zomig Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of the nasal cavity; and dry mouth
Approved Use for Zomig

Zomig is a prescription medicine approved to treat migraine headaches in adults. Only your doctor can determine if Zomig is right for you.

Zomig should only be used where a clear diagnosis of migraine has been established. For a given migraine attack, if you do not respond to the first dose of Zomig, then your doctor will need to determine if you really have a migraine headache before you take a second dose. Zomig is not for the prevention of migraines or for the treatment of hemiplegic or basilar migraines (if you are not sure about this, ask your doctor). Zomig is not for other types of headaches, including cluster headache.

This is not a complete summary of safety information. Please discuss the full Prescribing Information with your doctor.

Click here to see the full Prescribing Information for Zomig Tablets and Zomig-ZMT Orally Disintegrating TabletsOpens in new window (PDF — 194KB)

Click here to see the full Prescribing Information for Zomig Nasal SprayOpens in new window (PDF — 122KB)

Click here to see Important Zomig Product Information for PatientsOpens in new window (PDF — 480KB)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.