Drug Safety Information for DIMENHYDRINATE (Dimenhydrinate)

Adverse Drug Reactions for DIMENHYDRINATE* (Dimenhydrinate)

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 DIMENHYDRINATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Vomiting113
2Nausea107
3Overdose57
4Dizziness53
5Diarrhoea52
6Somnolence*47
7Hallucination47
8Fatigue44
9Convulsion42
10Intentional drug misuse39
11Pyrexia38
12Intentional overdose38
13Pain37
14Dyspnoea37
15Dehydration34
16Drug ineffective34
17Headache33
18Malaise33
19Hypotension31
20Feeling abnormal30

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

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

Reason # of FDA Reports
1Product used for unknown indication555
2Nausea450
3Motion sickness*167
4Euphoric mood145
5Prophylaxis of nausea and vomiting145
6Vomiting111
7Premedication75
8Vomiting in pregnancy73
9Dizziness54
10Prophylaxis49

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


Types of Adverse Events for DIMENHYDRINATE

Total Reports Filed with FDA: 5647


Number of FDA Adverse Event Reports by Patient Age for DIMENHYDRINATE

Total Reports Filed with FDA: 5647*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dimenhydrinate (Vomacur, Airmit ace, Dramamine for kids, Dramamine orange, Travel ease, Wal-dram, Driminate, Vomex a, Dramamine, Dimetabs, Nausicalm, Vertigo-vomex, Apo-dimenhydrinate, Travel sickness, Dimenhydrinate)

Charts are based on 5647 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 DIMENHYDRINATE 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.