Drug Safety Information for TIGAN (Trimethobenzamide hydrochloride)

Adverse Drug Reactions for TIGAN* (Trimethobenzamide 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 TIGAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea96
2Pain60
3Vomiting56
4Fatigue50
5Drug ineffective*43
6Anxiety42
7Diarrhoea*42
8Dyspnoea40
9Fall40
10Dizziness*40
11Headache*38
12Insomnia36
13Depression35
14Abdominal pain35
15Asthenia34
16Pain in extremity32
17Hypertension29
18Weight decreased29
19Dehydration29
20Confusional state*27

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

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

Reason # of FDA Reports
1Product used for unknown indication502
2Nausea*468
3Vomiting73
4Abdominal discomfort14
5Hypersensitivity14
6Gastrooesophageal reflux disease12
7Prophylaxis of nausea and vomiting12
8Antiemetic supportive care7
9Gastric disorder6
10Irritable bowel syndrome6

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


Types of Adverse Events for TIGAN

Total Reports Filed with FDA: 5330


Number of FDA Adverse Event Reports by Patient Age for TIGAN

Total Reports Filed with FDA: 5330*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Trimethobenzamide hydrochloride (Trimazide, Tebamide, Tigan)

Charts are based on 5330 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 TIGAN 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.