Drug Safety Information for ZOMIG-ZMT (Zolmitriptan)

Safety-related Labeling Changes for ZOMIG (ZOLMITRIPTAN) Rx Drug: FDA Link

Safety-related Labeling Changes for ZOMIG-ZMT (ZOLMITRIPTAN) Rx Drug: FDA Link

Adverse Drug Reactions for ZOMIG-ZMT* (Zolmitriptan)

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 ZOMIG-ZMT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Migraine563
2Headache345
3Drug dose omission286
4Drug ineffective212
5Pain*188
6Nausea*184
7Vomiting163
8Malaise128
9Dyspnoea126
10Fatigue*111
11Intentional drug misuse102
12Anxiety102
13Dizziness*102
14Depression93
15Feeling abnormal85
16Insomnia79
17Chest pain79
18Diarrhoea73
19Pulmonary embolism70
20Tremor68

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

Top 10 Reasons for Taking ZOMIG-ZMT
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Migraine*4449
2Headache*719
3Product used for unknown indication508
4Migraine with aura74
5Cluster headache*67
6Anxiety27
7Irritable bowel syndrome26
8Migraine without aura24
9Foetal exposure during pregnancy21
10Migraine prophylaxis17

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


Types of Adverse Events for ZOMIG-ZMT

Total Reports Filed with FDA: 12758


Number of FDA Adverse Event Reports by Patient Age for ZOMIG-ZMT

Total Reports Filed with FDA: 12758*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Zolmitriptan (Zomig zmt, Zolmiptriptan, Ascotop, Zomigoro, Zolmitriptan, Zomig-zmt, Zomig)

Charts are based on 12758 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.

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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.

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