Drug Safety Information for AMERGE (Naratriptan hydrochloride)

Safety-related Labeling Changes for AMERGE (NARATRIPTAN HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for AMERGE* (Naratriptan hydrochloride)

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 AMERGE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective108
2Nausea*64
3Headache54
4Migraine47
5Pain*40
6Fatigue*36
7Anxiety34
8Vomiting33
9Dyspnoea29
10Dizziness*28
11Product quality issue27
12Depression25
13Chest pain23
14Convulsion23
15Arthralgia22
16Diarrhoea21
17Pulmonary embolism20
18Feeling abnormal20
19Abdominal pain upper20
20Tremor19

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

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

Reason # of FDA Reports
1Migraine*945
2Product used for unknown indication184
3Headache116
4Cluster headache8
5Migraine prophylaxis6
6Ill-defined disorder6
7Herpes zoster2
8Pain1
9Abortion1

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


Types of Adverse Events for AMERGE

Total Reports Filed with FDA: 3044


Number of FDA Adverse Event Reports by Patient Age for AMERGE

Total Reports Filed with FDA: 3044*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Naratriptan hydrochloride (Naratriptan, Amerge)

Charts are based on 3044 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 AMERGE 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.