Drug Safety Information for IMITREX (Sumatriptan succinate)

FDA Safety-related Labeling Changes for IMITREX (SUMATRIPTAN SUCCINATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for SUMAVEL DOSEPRO (SUMATRIPTAN SUCCINATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for ZEMBRACE SYMTOUCH (SUMATRIPTAN SUCCINATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for IMITREX* (Sumatriptan succinate)

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 IMITREX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective3134
2Product quality issue1512
3Nausea*1224
4Headache*1196
5Migraine1093
6Pain*852
7Vomiting744
8Dizziness*613
9Dyspnoea602
10Fatigue*599
11Injection site pain575
12Chest pain544
13Anxiety523
14Drug dose omission417
15Depression416
16Chest discomfort*401
17Malaise390
18Diarrhoea383
19Feeling abnormal380
20Pain in extremity355

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

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

Reason # of FDA Reports
1Migraine*26987
2Product used for unknown indication5664
3Headache*2644
4Cluster headache*399
5Pain146
6Ill-defined disorder117
7Foetal exposure during pregnancy73
8Migraine prophylaxis63
9Migraine without aura*57
10Nervous system disorder37

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


Types of Adverse Events for IMITREX

Total Reports Filed with FDA: 63540


Number of FDA Adverse Event Reports by Patient Age for IMITREX

Total Reports Filed with FDA: 63540*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sumatriptan succinate (Sumavel dosepro, Imigran, Imitrex statdose, Imitrex, Sumatriptan, Alsuma)

Charts are based on 63540 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 IMITREX 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.