Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial ischemia and myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions ( 5.2 )] Arrhythmias [see Warnings and Precautions ( 5.3 )] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions ( 5.4 )] 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 ) and Warnings and Precautions ( 5.9 )] Most common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence.
These reactions appear to be dose-related.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc.
at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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 4,597 patients who treated the first migraine headache with eletriptan hydrobromide tablets in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with eletriptan hydrobromide tablets were asthenia, nausea, dizziness, and somnolence.
These reactions appear to be dose-related.
In long-term open-label studies where patients were allowed to treat multiple migraine attacks for up to 1 year, 128 (8.3%) out of 1,544 patients discontinued treatment due to adverse reactions.
Table 1 lists adverse reactions that occurred in the subset of 5,125 migraineurs who received eletriptan doses of 20 mg, 40 mg and 80 mg or placebo in worldwide placebo-controlled clinical trials.
Only adverse reactions that were more frequent in a eletriptan hydrobromide tablets treatment group compared to the placebo group with an incidence greater than or equal to 2% are included in Table
5 WARNINGS AND PRECAUTIONS Eletriptan hydrobromide tablets should only be used where a clear diagnosis of migraine has been established.
Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias: Discontinue eletriptan hydrobromide tablets if occurs ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not myocardial ischemia;
evaluate high risk patients for CAD ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, or stroke: Discontinue eletriptan hydrobromide tablets if occurs ( 5.4 ) Gastrointestinal ischemia or infarction events, or peripheral vasospastic reactions: Discontinue eletriptan hydrobromide tablets if occurs ( 5.5 ) Medication overuse headache: Detoxification may be necessary ( 5.6 ) Serotonin syndrome: Discontinue eletriptan hydrobromide tablets if occurs ( 5.7 , 7.3 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Eletriptan hydrobromide tablets are contraindicated in patients with ischemic or vasospastic CAD.
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of eletriptan hydrobromide tablets.
Some of these reactions occurred in patients without known CAD.
Like all medications, Eletriptan Hydrobromide can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: