Navigation

Zomig

  • Generic Name: zolmitriptan
  • Brand Name: Zomig

Zomig (Zolmitriptan) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Zomig Side Effects Center

What Is Zomig?

Zomig (zolmitriptan) is a headache medicine that narrows blood vessels around the brain used to treat migraine headaches. Zomig will only treat a headache that has already begun. Zomig will not prevent headaches or reduce the number of attacks.

What Are Side Effects of Zomig?

Common side effects of Zomig include:

  • unusual or unpleasant taste in your mouth,
  • discomfort in the nose or throat after using the nasal spray,
  • warmth/redness/tingling/numbness under the skin,
  • nausea,
  • dry mouth,
  • weakness,
  • drowsiness,
  • dizziness, or
  • pressure or heavy feeling in any part of your body.

Dosage for Zomig

The initial dose of Zomig is 2.5 mg or less. The dose can be repeated after 2 hours if symptoms persist. The maximum dose is 10 mg per day.

What Drugs, Substances, or Supplements Interact with Zomig?

Zomig may interact with other migraine headache medicines, cimetidine, or antidepressants. Tell your doctor all medications you are taking.

Zomig During Pregnancy and Breastfeeding

During pregnancy, Zomig should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Additional Information

Our Zomig (zolmitriptan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zomig Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using zolmitriptan and call your doctor at once if you have:

  • feeling of tightness in your jaw, neck, throat, or chest;
  • fast or pounding heartbeats, dizziness;
  • sudden and severe stomach pain and bloody diarrhea;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

  • pain or tightness in your throat or chest;
  • dry mouth, upset stomach;
  • pressure or heavy feeling anywhere in your body;
  • drowsiness, feeling tired; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zomig (Zolmitriptan)

 

Zomig Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in other sections of the prescribing information:

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

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 reaction.

The most common adverse reactions (≥ 5% and > placebo) in these trials were neck/throat/jaw pain, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth.

Table 1 lists the adverse reactions that occurred in ≥ 2% of the 2,074 patients in any one of the ZOMIG 1 mg, 2.5 mg, or 5 mg dose groups in the controlled clinical trials of ZOMIG in patients with migraines (Studies 1, 2, 3, 4, and 5) [see Clinical Studies]. Only adverse reactions that were at least 2% more frequent in a ZOMIG group compared to the placebo group are included.

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

Table 1: Adverse Reaction Incidence in Five Pooled Placebo-Controlled Migraine Clinical Trials1

  Placebo
(n=401) 		ZOMIG 1 mg
(n=163) 		ZOMIG 2.5 mg
(n=498) 		ZOMIG 5 mg
(n=1012)
ATYPICAL SENSATIONS 6% 12% 12% 18%
Paresthesia (all types) 2% 5% 7% 9%
Warm/cold sensation 4% 6% 5% 7%
PAIN AND PRESSURE SENSATIONS 7% 13% 14% 22%
Chest - pain/tightness/pressure and/or heaviness 1% 2% 3% 4%
Neck/throat/jaw -pain/tightness/pressure 3% 4% 7% 10%
Heaviness other than chest or neck 1% 1% 2% 5%
Other- Pressure/tightness/heaviness 0 2% 2% 2%
DIGESTIVE 8% 11% 16% 14%
Dry mouth 2% 5% 3% 3%
Dyspepsia 1% 3% 2% 1%
Dysphagia 0% 0% 0% 2%
Nausea 4% 4% 9% 6%
NEUROLOGICAL 10% 11% 17% 21%
Dizziness 4% 6% 8% 10%
Somnolence 3% 5% 6% 8%
Vertigo 0% 0% 0% 2%
OTHER        
Asthenia 3% 5% 3% 9%
Sweating 1% 0% 2% 3%
1 Only adverse reactions that were at least 2% more frequent in a ZOMIG group compared to the placebo group are included.

There were no differences in the incidence of adverse reactions in controlled clinical trials in the following subgroups: gender, weight, age, use of prophylactic medications, or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Less Common Adverse Reactions with ZOMIG Tablets

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled studies, the role of ZOMIG in their causation cannot be reliably determined. Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Adverse reaction frequencies were calculated as the number of patients who used ZOMIG tablets and reported a reaction divided by the total number of patients exposed to ZOMIG tablets (n=4,027). Reactions were further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse reactions (those occurring in 1/100 to 1/1,000 patients) and rare adverse reactions (those occurring in less than 1/1,000 patients).

General: Infrequent were allergic reactions.

Cardiovascular: Infrequent were arrhythmias, hypertension, and syncope. Rare was tachycardia.

Neurological: Infrequent were agitation, anxiety, depression, emotional lability and insomnia; Rare were amnesia, hallucinations, and cerebral ischemia.

Skin: Infrequent were pruritus, rash and urticaria.

Urogenital: Infrequent were polyuria, urinary frequency and urinary urgency.

Adverse Reactions with ZOMIG-ZMT Oral Disintegrating Tablets

The adverse reaction profile seen with ZOMIG-ZMT oral disintegrating tablets was similar to that seen with ZOMIG tablets.

Postmarketing Experience

The following adverse reactions were identified during post approval use of ZOMIG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The reactions enumerated include all except those already listed in the Clinical Trials Experience section above or the Warnings and Precautions section.

Hypersensitivity Reactions:

As with other 5-HT1B/1D agonists, there have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving ZOMIG. ZOMIG is contraindicated in patients with a history of hypersensitivity reaction to ZOMIG.

Read the entire FDA prescribing information for Zomig (Zolmitriptan)

&Copy; Zomig Patient Information is supplied by Cerner Multum, Inc. and Zomig Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.