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Approved Use and Important Safety Information for ZOMIG

Approved Use for ZOMIG

ZOMIG is a prescription medication used for the treatment of migraine headaches in adults. ZOMIG is not for the prevention of migraines. ZOMIG is not for other types of headaches.

Important Safety Information

  • Do not take ZOMIG if your headache is not a migraine
  • Do not take ZOMIG if your headache is hemiplegic or basilar migraine (If you are unsure about this, ask your doctor)
  • Do not take ZOMIG if you have heart disease, history of, or risk factors for heart disease, uncontrolled high blood pressure, circulation (blood flow) problems, or have had a stroke. Only your doctor can determine if ZOMIG is right for you
  • ZOMIG should not be used within 24 hours of another 5-HT1 agonist (triptans), ergotamine-containing or ergot-type medication (for headache), or within 2 weeks of an MAO-A inhibitor (for depression)
  • Talk to your doctor if you are pregnant, planning to become pregnant, or breastfeeding because ZOMIG may not be right for you
  • ZOMIG, like other triptans, may be associated with a potentially life-threatening condition called serotonin syndrome, mainly when taken together with certain antidepressants. Inform your doctor of all your medications prior to taking ZOMIG
  • Phenylketonurics: ZOMIG-ZMT® (zolmitriptan) Orally Disintegrating Tablets contain phenylalanine, a component of aspartame
  • Safety and effectiveness of ZOMIG in pediatric patients have not been established
  • Side Effects: The most common side effects reported by patients in clinical trials with ZOMIG Nasal Spray include unusual taste, tingling sensation, skin sensitivity, and dizziness
  • Side Effects: The most common side effects reported by patients in clinical trials with ZOMIG Tablets and ZOMIG-ZMT include dizziness; tightness, pressure, pain in the neck, throat, or jaw; fatigue; tingling; drowsiness; and nausea

Talk to your doctor about prescription ZOMIG.

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

Click here to see the Prescribing Information for ZOMIG Nasal Spray Opens in new window (PDF — 122KB)

Click here to see the Important ZOMIG Product Information for Patients Opens 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.