Zomig Side Effects
Generic Name: Zolmitriptan
Please note - some side effects for Zomig may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Zomig - for the consumer
Zomig
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zomig:
Seek medical attention right away if any of these SEVERE side effects occur when using Zomig:Abnormal skin sensations; dizziness; drowsiness; increased sensitivity to touch; nausea; pain; warm/cold sensations; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); heart attack; pounding in the chest; tightness, pain, pressure, or heaviness in jaw, neck, throat, and chest.
Zomig ZMT Disintegrating Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zomig ZMT Disintegrating Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Zomig ZMT Disintegrating Tablets:Abnormal skin sensations; dizziness; drowsiness; increased sensitivity to touch; nausea; pain; warm/cold sensations; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); heart attack; pounding in the chest; tightness, pain, pressure, or heaviness in jaw, neck, throat, and chest.
Zomig Spray
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zomig Spray:
Seek medical attention right away if any of these SEVERE side effects occur when using Zomig Spray:Abnormal skin sensations; dizziness; drowsiness; increased sensitivity to touch; nausea; pain; warm/cold sensations; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pounding in the chest; tightness, pain, pressure, or heaviness in jaw, neck, throat, and chest.
For the professional
Zomig
Serious cardiac events, including myocardial infarction, have occurred following the use of Zomig Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported, in association with drugs of this class, have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation.
Incidence in Controlled Clinical Trials:
Among 2,633 patients treated with Zomig Tablets in the active and placebo controlled trials, no patients withdrew for reasons related to adverse events, but as patients treated a single headache in these trials, the opportunity for discontinuation was limited. 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 experience. The most common events were paresthesia, asthenia, nausea, dizziness, pain, chest or neck tightness or heaviness, somnolence, and warm sensation.
Table 2 lists the adverse events that occurred in ≥ 2% of the 2,074 patients in any one of the Zomig 1 mg, Zomig 2.5 mg or Zomig 5 mg Tablets dose groups of the controlled clinical trials. Only events that were more frequent in a Zomig Tablets group compared to the placebo groups are included. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
Several of the adverse events appear dose related, notably paresthesia, sensation of heaviness or tightness in chest, neck, jaw, and throat, dizziness, somnolence, and possibly asthenia and nausea.
Adverse Event Type |
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% |
Hyperesthesia |
1% |
1% |
1% |
2% |
Paresthesia (all types) |
2% |
5% |
7% |
9% |
Sensation warm/cold |
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% |
Pain − location specified |
1% |
2% |
2% |
3% |
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 |
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Asthenia |
3% |
5% |
3% |
9% |
Palpitations |
1% |
0% |
<1% |
2% |
Myalgia |
<1% |
1% |
1% |
2% |
Myasthenia |
<1% |
0% |
1% |
2% |
Sweating |
1% |
0% |
2% |
3% |
Zomig is generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse events.
Other Events:
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of Zomig in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used Zomig Tablets (n=4,027) and reported an event divided by the total number of patients exposed to Zomig Tablets. All reported events 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. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare adverse events are those occurring in fewer than 1/1,000 patients.
Atypical sensations: Infrequent was hyperesthesia.
General: Infrequent were allergy reaction, chills, facial edema, fever, malaise, and photosensitivity.
Cardiovascular: Infrequent were arrhythmias, hypertension, and syncope. Rare were bradycardia, extrasystoles, postural hypotension, QT prolongation, tachycardia, and thrombophlebitis.
Digestive: Infrequent were increased appetite, tongue edema, esophagitis, gastroenteritis, liver function abnormality, and thirst. Rare were anorexia, constipation, gastritis, hematemesis, pancreatitis, melena, and ulcer.
Hemic: Infrequent was ecchymosis. Rare were cyanosis, thrombocytopenia, eosinophilia, and leukopenia.
Metabolic: Infrequent was edema. Rare were hyperglycemia and alkaline phosphatase increased.
Musculoskeletal: Infrequent were back pain, leg cramps, and tenosynovitis. Rare were arthritis, asthenia, tetany, and twitching.
Neurological: Infrequent were agitation, anxiety, depression, emotional lability, and insomnia. Rare were akathisia, amnesia, apathy, ataxia, dystonia, euphoria, hallucinations, cerebral ischemia, hyperkinesia, hypotonia, hypertonia, and irritability.
Respiratory: Infrequent were bronchitis, bronchospasm, epistaxis, hiccup, laryngitis, and yawn. Rare were apnea and voice alteration.
Skin: Infrequent were pruritus, rash, and urticaria.
Special Senses: Infrequent were dry eye, eye pain, hyperacusis, ear pain, parosmia, and tinnitus. Rare were diplopia and lacrimation.
Urogenital: Infrequent were hematuria, cystitis, polyuria, urinary frequency, urinary urgency. Rare were miscarriage and dysmenorrhea.
The adverse experiences profile seen with Zomig-ZMT Tablets was similar to that seen with Zomig Tablets.
Postmarketing Experience with Zomig Tablets:
The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and non-domestic use of oral zolmitriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of zolmitriptan in their causation cannot be reliably determined.
Cardiovascular:
Coronary artery vasospasm; transient myocardial ischemia, angina pectoris, and myocardial infarction.
Digestive:
Very rare gastrointestinal ischemic events including splenic infarction, ischemic colitis and gastrointestinal infarction or necrosis have been reported; these may present as bloody diarrhea or abdominal pain.
Neurological:
As with other acute migraine treatments including other 5HT1 agonists, there have been rare reports of headache.
General:
As with other 5-HT1B/1D agonists, there have been very rare reports of anaphylaxis or anaphylactoid reactions in patients receiving Zomig. There have been rare reports of hypersensitivity reactions, including angioedema.
Serotonin syndrome has also been reported during the postmarketing period.
TopZomig Nasal Spray
Serious cardiac events, including myocardial infarction, have occurred following the use of Zomig Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported, in association with drugs of this class, have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation.
Incidence in Controlled Clinical Trials:
Among 464 patients treating single attacks with zolmitriptan nasal spray in a blinded placebo controlled trial, there was a low withdrawal rate related to adverse events: 5 mg (1.3%), 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 events in clinical trials for Zomig Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness. Table 2 lists the adverse events that occurred in ≥ 2% of the 236 patients in the 5 mg dose group of the controlled clinical trial.
Body system and Adverse event |
Zolmitriptan nasal spray |
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Placebo (N=228) |
5.0 mg (N=236) |
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ATYPICAL SENSATIONS | ||
Hyperesthesia |
0% |
5% |
Paraesthesia |
6% |
10% |
EAR/NOSE/THROAT | ||
Disorder/Discomfort of nasal cavity |
2% |
3% |
PAIN AND PRESSURE SENSATIONS | ||
Pain Location Specified |
1% |
4% |
Pain Throat |
1% |
4% |
Tightness Throat |
1% |
2% |
DIGESTIVE | ||
Dry Mouth |
0% |
2% |
Nausea |
1% |
4% |
NEUROLOGICAL | ||
Dizziness |
4% |
3% |
Somnolence |
2% |
4% |
Unusual Taste |
3% |
21% |
OTHER | ||
Asthenia |
1% |
3% |
Adverse clinical events occurring in ≥ 1% and < 2% of patients in all attacks of the controlled clinical trial were pain abdominal, pressure throat, vomiting, headache, tightness chest, dysphagia, insomnia, palpitation and reaction aggravation.
Zomig is generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events 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 events.
Other Events:
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of Zomig in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used Zomig Nasal Spray and reported an event divided by the total number of patients exposed to Zomig Nasal Spray (n=3059). All reported events 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. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare adverse events are those occurring in fewer than 1/1,000 patients.
Body:Infrequent was allergic reaction, back pain, chills, cyst, flu syndrome, infection, jaw pain, pressure other, jaw tightening, edema of the face, abnormal laboratory test, neck pain, neoplasm, and neck tightness, chest heaviness, chest pain, and chest pressure. Rare were cellulitis, fever, jaw pressure, and neck heaviness.
Cardiovascular:Infrequent were arrhythmias, hypertension, syncope, thrombophlebitis, and tachycardia. Rare were angina pectoris, bradycardia, atrial fibrillation, myocardial infarct, vasodilation, and vascular disorder.
Digestive:Infrequent were diarrhea, dyspepsia, tongue edema, gastrointestinal disorder, increased saliva, and thirst. Rare were increased appetite, colitis, constipation, eructation, gastritis, gastrointestinal carcinoma, gingivitis, hepatic neoplasia, intestinal obstruction, jaundice, sialadenitis, and stomatitis.
Endocrine System:Rare were hyperthyroidism and thyroid edema.
Hemic:Infrequent was cyanosis. Rare were ecchymosis, lymphadenopathy and leukopenia.
Metabolic Nutritional:Rare were increased weight, dehydration, and peripheral edema.
Musculoskeletal:Infrequent were arthralgia, joint disorder, and myalgia. Rare were bone pain, osteoporosis, tenosynovitis and twitching.
Nervous System:Infrequent were agitation, amnesia, anxiety, ataxia, abnormal coordination, confusion, depersonalization, depression, hypertonia, insomnia, nervousness, speech disorder, abnormal thinking, tremor, vertigo, and circumoral paresthesia.
Rare were apathy, convulsions, abnormal dreams, euphoria, hypertonia, irritability tardive dyskinesia, manic reaction, neuropathy, and psychosis.
Respiratory:Infrequent were bronchitis, increased cough, dyspnea, epistaxis, laryngeal edema, pharyngitis, rhinitis, sinusitis, throat discomfort, and voice alteration. Rare was hiccup, hyperventilation, laryngitis, pneumonia, increased sputum, and yawning.
Skin:Infrequent was pruritus, rash, skin disorder, and sweating. Rare were eczema, erythema, erythema multiform, hair disorder, and neoplasm.
Special Senses:Infrequent were amblyopia, disorder of lacrimation, ear pain, eye pain, parosmia and tinnitus. Rare were conjunctivitis, dry eye, photophobia, and visual field defect.
Urogenital:Infrequent was polyuria and menorrhagia. Rare were breast carcinoma, dysmenorrhea, metrorrhagia, breast neoplasm, unintended pregnancy, suspicious PAP smear, uterine disorder, enlarged uterine fibroids, fibrocytic breast, vaginitis, urogenital neoplasm, cystitis, urinary tract infection, kidney pain, pyelonephritis, urinary frequency, urine impaired, and urinary tract disorder.
The adverse experience 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 effects from the nasal spray.
Postmarketing Experience with Zomig Tablets:
The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and non-domestic use of oral zolmitriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of zolmitriptan in their causation cannot be reliably determined.
Cardiovascular:Coronary artery vasospasm, transient myocardial ischemia, angina pectoris, and myocardial infarction.
Digestive:Very rare gastrointestinal ischemic events including splenic infarction, ischemic colitis and gastrointestinal infarction or necrosis have been reported; these may present as bloody diarrhea or abdominal pain.
Neurological:As with other acute migraine treatments including other 5HT1 agonists, there have been rare reports of headache.
General:As with other 5-HT1B/1D agonists, there have been very rare reports of anaphylaxis or anaphylactoid reactions in patients receiving Zomig. There have been rare reports of hypersensitivity reactions, including angioedema.
Serotonin syndrome has also been reported during the postmarketing period.
Top
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