July 29, 2015
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Zomig

" Migraine medications overview

Migraine is a serious, potentially life-threatening neurological disease that affects nearly 36 million Americans, the majority of whom are women. The American Migraine Foundation estimates that one in ev"...

Zomig




Zomig Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/30/2015

Zomig (zolmitriptan) is a vasoconstrictor used to treat migraine headaches that have already begun. Zomig will not prevent headaches or reduce the number of attacks. Zomig is not used to treat common tension headaches or any headache that is not a migraine headache as diagnosed by a doctor. Common side effects of Zomig include tingling/numbness/warmth/redness of your skin, nausea, dry mouth, upset stomach, pressure or heavy feeling in any part of your body, feeling of pain or pressure in your neck or throat, weakness, drowsiness, or dizziness.

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

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zomig in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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 a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • fast or pounding heartbeats, dizziness;
  • sudden and severe stomach pain and bloody diarrhea;
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • pressure or heavy feeling in any part of your body;
  • dry mouth, upset stomach;
  • feeling of pain or pressure in your neck or throat;
  • drowsiness, weakness; or
  • warmth, redness, or mild tingling under your skin.

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zomig Overview - Patient Information: Side Effects

SIDE EFFECTS: Tingling/numbness, nausea, dry mouth, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet.

Chest/jaw/neck tightness can commonly occur soon after using zolmitriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due to a lack of blood flow to the heart, brain, or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea, change in the amount of urine.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zomig (Zolmitriptan)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zomig FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of labeling:

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.

Adults

Among 460 patients treating 1180 single attacks with ZOMIG nasal spray in a blinded placebo controlled trial (Study 1), there was a low withdrawal rate related to adverse reactions: 5 mg (1.3%), 2.5 mg (0%), and placebo (0.4%). None of the withdrawals were due to a serious event. One patient was withdrawn due to abnormal ECG changes from baseline that were incidentally found 23 days after the last dose of ZOMIG nasal spray.

The most common adverse reactions ( ≥ 5% and > placebo) in any dosage strength in clinical trials for ZOMIG nasal spray were: unusual taste, paresthesia, hyperesthesia, and dizziness. The incidence of adverse reactions was generally dose-related.

Table 1 lists the adverse reactions from the controlled clinical trial (Study 1) that occurred in ≥ 2% of patients in either the 2.5 or 5 mg ZOMIG nasal spray dose groups and with an incidence greater than placebo.

Table 1: Adverse reactions in a Placebo-Controlled Study in Adult Patients with Migraine (Study 1)

Body System Adverse Reaction Placebo
(N=228)
ZOMIG 2.5 mg
(N=224)
ZOMIG 5 mg
(N=236)
Atypical Sensations
Hyperesthesia 0% 1% 5%
Paraesthesia 6% 5% 10%
Warm Sensation 2% 4% 0%
Ear/Nose/Throat
Disorder/Discomfort of nasal cavity 2% 1% 3%
Pain and Pressure Sensations
Pain Location Specified 1% 2% 4%
Throat Pain 1% 4% 4%
Throat Tightness 1% < 1% 2%
Digestive
Dry Mouth < 1% 3% 2%
Nausea 1% 1% 4%
Neurological
Dizziness 4% 6% 3%
Somnolence 2% 1% 4%
Other
Unusual Taste 3% 17% 21%
Asthenia 1% 3% 3%

In Study 1, adverse reactions occurring in ≥ 1% and < 2% of patients in all attacks in either ZOMIG nasal spray dose group and with incidence greater than that of placebo were: abdominal pain, chills, throat pressure, facial edema, chest pressure, palpitation, dysphagia, arthralgia, myalgia, and depersonalization.

The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients (18-39 vs. 40-65 years of age), or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Local Adverse Reactions

Among 460 patients using ZOMIG 2.5 mg or 5 mg in the controlled clinical trial, approximately 3% noted local irritation or soreness at the site of administration. Adverse reactions of any kind, perceived in the nasopharynx (which may include systemic effects of triptans) were severe in about 1% of patients and approximately 57% resolved in 1 hour. Nasopharyngeal examinations, in a subset of patients participating in two long term trials of up to one year duration, failed to demonstrate any clinically significant changes with repeated use of ZOMIG nasal spray.

All nasopharyngeal adverse reactions with an incidence of ≥ 2% of patients in any ZOMIG nasal spray dose groups are included in Table 1.

Other Adverse Reactions

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. Reaction frequencies are calculated as the number of patients who used ZOMIG nasal spray and reported a reaction divided by the total number of patients exposed to ZOMIG nasal spray (n=3059). All reported reactions 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. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients and rare adverse reactions are those occurring in fewer than 1/1,000 patients.

General: Infrequent: allergic reactions.

Cardiovascular: Infrequent: arrhythmias, hypertension, syncope and tachycardia. Rare: angina pectoris and myocardial infarct.

Digestive: Rare: stomatitis.

Neurological: Infrequent: agitation, amnesia, anxiety, depression, insomnia, and nervousness. Rare: convulsions.

Respiratory: Infrequent: bronchitis, increased cough, dyspnea, epistaxis, laryngeal edema, pharyngitis, rhinitis, and sinusitis.

Skin: Infrequent: pruritus, rash, and urticaria.

Urogenital: Infrequent: polyuria and urinary urgency. Rare: urinary frequency.

Special senses: Infrequent: tinnitus. Rare: conjunctivitis, dry eye, and visual field defect.

The adverse reaction profile seen with ZOMIG nasal spray is similar to that seen with ZOMIG tablets and ZOMIG-ZMT tablets except for the occurrence of local adverse reactions from the nasal spray (see ZOMIG tablet/ZOMIG-ZMT oral disintegrating tablet Prescribing Information).

Pediatric Patients 12 to 17 Years of Age

The safety of ZOMIG nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in two studies [see Pediatric Use and Clinical Studies].

The most common adverse reactions (incidence of ≥ 2% of pediatric patients receiving 2.5 mg and 5 mg ZOMIG nasal spray and numerically greater than placebo) after a single dose are summarized in Table 2. Dysgeusia (unusual taste) was the most common adverse reaction, with a numerically greater incidence for patients receiving ZOMIG compared to placebo (10% vs. 2%). Other common adverse reactions were nasal discomfort, dizziness, oropharyngeal pain, and nausea.

Table 2 lists the adverse reactions from the pooled placebo-controlled studies that occurred in ≥ 2% of pediatric patients 12 to 17 years of age in either the 2.5 mg or 5 mg ZOMIG dose groups and with an incidence greater than placebo.

Table 2: Adverse reactions in Pooled Placebo-Controlled Studies in Pediatric Patients 12 to 17 years of Age with Migraine

Adverse Reaction Placebo
(N=437)
ZOMIG 2.5 mg
(N=81)
ZOMIG 5 mg
(N=431)
Unusual taste 2% 6% 10%
Nasal discomfort 1% 3% 3%
Dizziness 1% 0% 2%
Oropharyngeal pain 2% 0% 2%
Nausea 1% 1% 2%

The adverse reaction profile was similar across gender. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

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

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)

Zomig - User Reviews

Zomig User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Zomig sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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