- A Visual Guide to Migraine Headaches Slideshow
- Headache and Migraine Triggers Slideshow
- Take the Migraines Quiz
What is Zomig (zolmitriptan)?
Zomig causes constriction of the blood vessels and thereby relieves the pain of a migraine headache. While Zomig is effective in relieving migraine headaches, it does not prevent or reduce the number of headaches if taken prophylactically.
Common side effects of Zomig are usually temporary and include:
- pain or tightness in the chest or throat,
- tingling sensations,
- abdominal discomfort, and
Serious side effects of Zomig include allergic reactions.
- Symptoms include:
Serotonin reuptake inhibitors (SSRIs) taken with Zomig may lead to exaggerated effects of serotonin, which can include weakness, increased reflexes, and loss of coordination.
Combining ergots and Zomig may result in exaggerated spasm of blood vessels.
Cimetidine taken with Zomig may lead to Zomig toxicity.
What are the important side effects of Zomig (zolmitriptan)?
Side effects are generally transient. Some common side effects include:
- pain or tightness in the chest or throat,
- tingling sensations,
- abdominal discomfort, and
Rarely, allergic reactions (even shock) have been reported though usually in individuals who are highly allergic to many substances.
Zomig (zolmitriptan) side effects list for healthcare professionals
The following adverse reactions are described elsewhere in other sections of the prescribing information:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina.
- Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure.
- Cerebrovascular Events.
- Other Vasospasm Reactions.
- Medication Overuse Headache.
- Serotonin Syndrome.
- Increase in Blood Pressure.
- Risks in Patients with Phenylketonuria.
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). 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
|Zomig 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%|
|Heaviness other than chest or neck||1%||1%||2%||5%|
|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.
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.
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.
What drugs interact with Zomig (zolmitriptan)?
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Zomig within 24 hours of each other is contraindicated).
MAO-A inhibitors increase the systemic exposure of zolmitriptan and its active N-desmethyl metabolite. Therefore, the use of Zomig in patients receiving MAO-A inhibitors is contraindicated.
Concomitant use of other 5-HT1B/1D agonists (including triptans) within 24 hours of Zomig treatment is contraindicated because the risk of vasospastic reactions may be additive).
Selective Serotonin Reuptake Inhibitors And Serotonin Norepinephrine Reuptake Inhibitors
Cases of life-threatening serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
Following administration of cimetidine, the half-life and blood levels of zolmitriptan and its active N-desmethyl metabolite were approximately doubled. If cimetidine and Zomig are used concomitantly, limit the maximum single dose of Zomig to 2.5 mg, not to exceed 5 mg in any 24-hour period.
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Related Disease Conditions
Migraine headache is a type of headache associated with a sensitivity to light, smells, or sounds, eye pain, severe pounding on one side of the head, and sometimes nausea and vomiting. The exact cause of migraine headaches is not known. Triggers for migraine headaches include certain foods, stress, hormonal changes, strong stimuli (loud noises), and oversleeping. Treatment guidelines for migraines include medicine, pain management, diet changes, avoiding foods that trigger migraines, staying hydrated, getting adequate sleep, and exercising regularly. Prevention of migraine triggers include getting regular exercise, drinking water daily, reducing stress, and avoiding trigger foods.
Migraines and Seizures (Symptoms, Auras, Medication)
Migraines are a type of headache and seizures are the main symptom of epilepsy. Migraine headaches and seizures are two different neurological problems that have similar signs, symptoms, and auras, for example, sensitivity to light (photophobia) and sound, irritability, nausea, and vomiting. Symptoms unique to migraine and migraine auras are water retention, problems sleeping, appetite changes, and talkativeness. Symptoms unique to seizure and seizures auras are depression, a feeling of heaviness, a feeling that a seizure is approaching, and depression. Many of the symptoms of migraine and seizures are the same, however, seizures do not cause migraines; however, people who have seizures are twice as likely to have migraines and vice-versa. People who have migraines are twice as likely to have seizures, and people with seizures are twice as likely to have migraines; however, one condition does not cause the other.
Migraine and Stroke
Migraine headache is a type of headache in which the exact cause is not known; however, they may be inherited, and certain foods and environmental factors can trigger and may contribute them. A stroke (brain attack) happens when a blood vessel in the brain leaks, bursts, or becomes blocked, which can be caused by many other health problems. Both migraines and strokes can can cause severe head pain (migraine pain usually is only on one side of the head). Migraine aura symptoms may mimic or feel like a stroke or mini-stroke (transient ischemic attack, TIA) because they have similar symptoms and signs like severe headache, numbness in the legs, feet, arms, hands, or face, nausea, vomiting, and dizziness. Other migraine aura symptoms include vision problems like flashing lights or blind spots in one eye. The main difference between migraine headache and stroke symptoms and signs is that a migraine headaches usually come on gradually while a stroke symptoms come on suddenly and unexpectedly.
Abdominal Migraines in Children and Adults
Abdominal Migraines in Children and Adults
Abdominal migraine in adults and children is a variant of migraine headaches. Abdominal migraine in children generally occurs in children who have a family history of migraines. Causes of abdominal migraine is not known. Symptoms of abdominal migraine include acute, severe, midline abdominal pain, nausea, vomiting, paleness, and inability to eat. Abdominal migraine is diagnosed through patient history, family history, and ruling out other medical causes. Treatment of abdominal migraine include tricyclic antidepressants and triptans.
Migraine vs. Headache: Differences and Similarities
Headaches are the most common reason why a person goes to the doctor or other healthcare professional for treatment. There are different types of headaches, for example, migraine, tension, and cluster headaches. The most common type of headache is tension headache. Migraine is much less common. There are few similarities between migraine and other headaches, for example, the severity of the pain can be the same, mild, moderate, or severe; and they can occur on one side or both sides of the head. However, there are many differences between migraine and other types of headaches. Migraine headaches also have different names, for example, migraine with aura and menstrual migraine. Symptoms of migraine that usually aren't experienced by a person with another type of headache include nausea, vomiting, worsens with mild exercise, debilitating pain, eye pain, throbbing head pain. Migraine trigger include light, mild exercise, strong smells, certain foods like red wine, aged cheese, smoked meats, artificial sweeteners, chocolate, alcohol, and dairy products, menstrual period, stress, oversleeping, and changes in barometric pressure. Untreated migraine attacks usually last from 4 to 72 hours, but may last for weeks. Most headaches resolve within 24-48 hours. Doctors don't know exactly what causes migraine headaches; however, other headaches like tension headaches have more specific triggers and causes. Additional tests usually are required to diagnose migraine from other types of headaches, diseases, or other medical problems. Most headaches can be treated and cured with home remedies like essential oils, massage, and over-the-counter pain medication like acetaminophen (Tylenol) and NSAIDs (nonsteroidal anti-inflammatory drugs) like naproxen (Aleve, Anaprox, Naprosyn) or ibuprofen (Advil, Midol, Motrin). Most headaches resolve with OTC and home remedy treatment, while your doctor may need to prescribe medication to treat your migraines. If you have the "worst headache of your life," seek medical care immediately.
Treatment & Diagnosis
Medications & Supplements
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.