Drug Safety Information for AXERT (Almotriptan malate)

FDA Safety-related Labeling Changes for AXERT (ALMOTRIPTAN MALATE) Discontinued Drug: Safety Information Link

Adverse Drug Reactions for AXERT* (Almotriptan malate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with AXERT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Migraine*47
2Pain*45
3Headache35
4Nausea34
5Drug ineffective*33
6Tremor30
7Dyspnoea27
8Dizziness26
9Vomiting26
10Pulmonary embolism25
11Chest pain25
12Fatigue23
13Anxiety22
14Injury21
15Chest discomfort20
16Abdominal pain upper20
17Asthenia19
18Depression19
19Deep vein thrombosis19
20Confusional state19

* This side effect also appears in "Top 10 Side Effects of AXERT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking AXERT
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Migraine*909
2Product used for unknown indication170
3Headache100
4Asthma11
5Drug abuse10
6Convulsion9
7Pain6
8Migraine without aura6
9Serotonin syndrome6
10Depression6

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for AXERT

Total Reports Filed with FDA: 2583


Number of FDA Adverse Event Reports by Patient Age for AXERT

Total Reports Filed with FDA: 2583*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Almotriptan malate (Almotriptan malate, Almogran, Almotriptan, Axert)

Charts are based on 2583 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and AXERT Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.