"The U.S. Food and Drug Administration today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance"...
Zomig Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zomig (zolmitriptan) is used to treat migraine headaches that have already begun. It will not prevent headaches or reduce the number of attacks. It is not used to treat common tension headaches or any headache that is not a migraine headache as diagnosed by a doctor. It is a vasoconstrictor. Common side effects include tingling/numbness, nausea, dry mouth, 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.
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
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.
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
The following adverse reactions are described elsewhere in other sections of the prescribing information:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina [see WARNINGS AND PRECAUTIONS].
- Arrthymias [see WARNINGS AND PRECAUTIONS].
- Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [see WARNINGS AND PRECAUTIONS].
- Cerebrovascular Events [see WARNINGS AND PRECAUTIONS].
- Other Vasospasm Reactions [see WARNINGS AND PRECAUTIONS].
- Medication Overuse Headache [see WARNINGS AND PRECAUTIONS].
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS].
- Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS].
- Risks in Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS].
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 1 mg
|ZOMIG 2.5 mg
|ZOMIG 5 mg
|Paresthesia (all types)||2%||5%||7%||9%|
|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%|
|1Only 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.
Neurological: Infrequent were agitation, anxiety, depression, emotional lability and insomnia; Rare were amnesia, hallucinations, and cerebral ischemia.
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.
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.
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) »
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