Almotriptan adverse reactions

Almotriptan
AXERT® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Almotriptan
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

Adverse Reactions

The most common adverse reactions (≥1% and greater than placebo) are:

• In adults: nausea, dry mouth and paresthesia
• In adolescents: dizziness, somnolence, headache, paresthesia, nausea and vomiting

Serious cardiac reactions, including myocardial infarction, have occurred following the use of Almotriptan (almotriptan malate) Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see Contraindications (4.1) and Warnings and Precautions (5.1)].

The following adverse reactions are discussed in more detail in other sections of the labeling:

Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events [see Warnings and Precautions (5.1)]

Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw [see Warnings and Precautions (5.2)]

Cerebrovascular Events and Fatalities [see Warnings and Precautions (5.3)]

Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and [see Colonic Ischemiaarnings and Precautions (5.4)]

Serotonin Syndrome [see Warnings and Precautions (5.5)]

Increases in Blood Pressure [see Warnings and Precautions (5.6)]

Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of Almotriptan and 386 adult patients who received placebo. The most common adverse reactions during treatment with Almotriptan were nausea, somnolence, headache, paresthesia, and dry mouth. In long-term open-label studies where patients were allowed to treat multiple attacks for up to 1 year, 5% (63 out of 1347 patients) withdrew due to adverse experiences.

Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received Almotriptan and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with Almotriptan were dizziness, somnolence, headache, paresthesia, nausea, and vomiting. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to 1 year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events.

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.

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Almotriptan Clinical Trials

Adults

Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with Almotriptan, and at an incidence greater than in patients treated with placebo, regardless of drug relationship.