Sumatriptanside effects

The following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina Arrhythmias Chest, throat, neck, and/or jaw pain/tightness/pressure Cerebrovascular events Other vasospasm reactions Medication overuse headache Serotonin syndrome Increase in blood pressure Local irritation Hypersensitivity reactions Seizures Most common adverse reactions (≥1% and >placebo) were burning sensation, disorder/discomfort of nasal cavity/sinuses, throat discomfort, nausea and/or vomiting, bad/unusual taste, and dizziness/vertigo. To report SUSPECTED ADVERSE REACTIONS, contact Florida Pharmaceutical Products, LLC at 1-800-315-0985 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. Table 1 lists adverse reactions that occurred in worldwide placebo-controlled clinical trials in 3,419 patients with migraine. Only treatment-emergent adverse reactions that occurred at a frequency of 1% or more in the group treated with sumatriptan nasal spray 20 mg and that occurred at a frequency greater than the placebo group are included in Table 1. Table 1. Adverse Reactions Reported by at Least 1% of Patients and at a Greater Frequency than Placebo in Controlled Migraine Clinical Trials Adverse Reaction Percent of Patients Reporting Sumatriptan Nasal Spray 5 mg (n = 496) Sumatriptan Nasal Spray 10 mg (n = 1,007) Sumatriptan Nasal Spray 20 mg (n = 1,212) Placebo (n = 704) Atypical sensations Burning sensation 0.4 0.6 1.4

0.1 Ear, nose, and throat

Disorder/discomfort of nasal cavity/sinuses 2.8 2.5 3.8 2.4 Throat discomfort 0.8 1.8 2.4

0.9 Gastrointestinal

Nausea and/or vomiting 12.2 11.0 13.5

11.3 Neurological

Bad/unusual taste 13.5 19.3 24.5 1.7 Dizziness/vertigo 1.0 1.7 1.4 0.9 The incidence of adverse reactions 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 reactions.

6.2 Postmarketing

Experience The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection. 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. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan or a combination of these factors.

Cardiovascular: Hypotension, palpitations.

Neurological: Dystonia, tremor.