"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
The following adverse reactions are discussed in more detail in other sections of labeling:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [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]
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.
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 One patient was withdrawn due to abnormal ECG changes from baseline that were incidentally found 23 days after the last dose of ZOMIG nasal spray.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
|ZOMIG 2.5 mg
|ZOMIG 5 mg
|Disorder/Discomfort of nasal cavity||2%||1%||3%|
|Pain and Pressure Sensations|
|Pain Location Specified||1%||2%||4%|
|Throat Tightness||1%||< 1%||2%|
|Dry Mouth||< 1%||3%||2%|
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.
Digestive: Rare: stomatitis.
Neurological: Infrequent: agitation, amnesia, anxiety, depression, insomnia, and nervousness. Rare: convulsions.
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 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
|ZOMIG 2.5 mg
|ZOMIG 5 mg
The adverse reaction profile was similar across gender. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
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.
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 Zomig (zolmitriptan) Side Effects Center for a complete guide to possible side effects
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 [see CONTRAINDICATIONS].
MAO-A inhibitors increase the systemic exposure of zolmitriptan. Therefore, the use of ZOMIG in patients receiving MAO-A inhibitors is contraindicated [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY].
5-HT1B/1D Agonists (e.g. triptans)
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 [see CONTRAINDICATIONS].
Following administration of cimetidine, the half-life and AUC of ZOMIG and its active metabolites were approximately doubled [see CLINICAL PHARMACOLOGY]. 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 [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors And Serotonin Syndrome
Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans [see WARNINGS AND PRECAUTIONS].
Read the Zomig Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/8/2015
This monograph has been modified to include the generic and brand name in many instances.
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