Drug Safety Information for ZELNORM (Tegaserod maleate)

Safety-related Labeling Changes for ZELNORM (TEGASEROD MALEATE) Rx Drug: FDA Link

Adverse Drug Reactions for ZELNORM* (Tegaserod maleate)

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 ZELNORM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*571
2Abdominal pain537
3Chest pain484
4Dizziness431
5Nausea417
6Dyspnoea403
7Constipation380
8Headache*304
9Vomiting278
10Pain255
11Asthenia252
12Drug ineffective*246
13Abdominal distension237
14Fatigue214
15Abdominal pain upper210
16Hypertension189
17Palpitations180
18Cerebrovascular accident180
19Myocardial infarction178
20Back pain170

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

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

Reason # of FDA Reports
1Irritable bowel syndrome*8035
2Constipation*4079
3Product used for unknown indication472
4Impaired gastric emptying353
5Gastrointestinal disorder256
6Gastric disorder256
7Abdominal pain185
8Abdominal distension180
9Dyspepsia173
10Gastrooesophageal reflux disease112

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


Types of Adverse Events for ZELNORM

Total Reports Filed with FDA: 27325


Number of FDA Adverse Event Reports by Patient Age for ZELNORM

Total Reports Filed with FDA: 27325*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tegaserod maleate (Zelmac, Tegaserod, Tegaserod maleate, Zelnorm)

Charts are based on 27325 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 ZELNORM 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.