Sumatriptan Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: · Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)] · Arrhythmias [see Warnings and Precautions (5.2)] · Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] · Cerebrovascular events [see Warnings and Precautions (5.4)] · Other vasospasm reactions [see Warnings and Precautions (5.5)] · Medication overuse headache [see Warnings and Precautions (5.6)] · Serotonin syndrome [see Warnings and Precautions (5.7)] · Increase in blood pressure [see Warnings and Precautions (5.8)] · Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.9)] · Seizures [see Warnings and Precautions (5.10)] Most common adverse reactions (≥5% and >placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Migraine Headache Table 1 lists adverse reactions that occurred in 2 U.S.

placebo-controlled clinical trials in patients with migraines (Studies 2 and 3) following either a single 6 mg dose of sumatriptan injection or placebo.

Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table

Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3) Adverse Reaction Sumatriptan Injection 6 mg Subcutaneous (n = 547)% Placebo (n = 370)% Atypical sensations Tingling Warm/hot sensation Burning sensation Feeling of heaviness Pressure sensation Feeling of tightness Numbness Feeling strange Tight feeling in head 42 14 11 7 7 7 5 5 2 2 9 3 4 <1 1 2 <1 2 <1 <1 Cardiovascular Flushing Chest discomfort Tightness in chest Pressure in chest 7 5 3 2 2 1 <1 <1 Ear, nose and throat throat discomfort discomfort: nasal cavity/sinuses 3 2 <1 <1 Injection site reaction a 59 24 Miscellaneous Jaw discomfort 2 0 Musculoskeletal Weakness Neck pain/stiffness Myalgia 5 5 2 <1 <1 <1 Neurological Dizziness/vertigo Drowsiness/sedation Headache 12 3 2 4 2 <1 Skin Sweating 2 1 a Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.

The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.

There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Cluster Headache In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in patients with migraine.

Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials.