Drug Safety Information for RELPAX (Eletriptan hydrobromide)

Safety-related Labeling Changes for RELPAX (ELETRIPTAN HYDROBROMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for RELPAX* (Eletriptan hydrobromide)

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 RELPAX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Migraine438
2Drug ineffective406
3Headache*351
4Nausea*216
5Pain*205
6Vomiting152
7Fatigue*135
8Dizziness*132
9Dyspnoea122
10Anxiety113
11Chest pain98
12Malaise97
13Somnolence*96
14Feeling abnormal92
15Depression82
16Pain in extremity77
17Chest discomfort*73
18Injury73
19Insomnia72
20Asthenia71

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

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

Reason # of FDA Reports
1Migraine*5425
2Headache762
3Product used for unknown indication669
4Ill-defined disorder258
5Migraine without aura130
6Migraine with aura40
7Pain35
8Multiple sclerosis18
9Migraine prophylaxis17
10Cluster headache*16

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


Types of Adverse Events for RELPAX

Total Reports Filed with FDA: 12317


Number of FDA Adverse Event Reports by Patient Age for RELPAX

Total Reports Filed with FDA: 12317*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Eletriptan hydrobromide (Eletriptan, Relpax)

Charts are based on 12317 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 RELPAX 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.