Drug Safety Information for DIMETAPP (Brompheniramine maleate; phenylpropanolamine hydrochloride)

Adverse Drug Reactions for DIMETAPP* (Brompheniramine maleate; phenylpropanolamine 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 DIMETAPP
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Cerebrovascular accident129
2Haemorrhagic stroke32
3Convulsion27
4Injury18
5Headache15
6Hemiparesis15
7Hypertension13
8Aneurysm12
9Subarachnoid haemorrhage11
10Amnesia11
11Cerebral haemorrhage11
12Myocardial infarction11
13Cerebral infarction10
14Intracranial aneurysm9
15Accidental overdose9
16Pain8
17Drug hypersensitivity8
18Overdose8
19Loss of consciousness8
20Dizziness8

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

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

Reason # of FDA Reports
1Nasopharyngitis142
2Influenza71
3Cough*61
4Sinus disorder42
5Product used for unknown indication36
6Hypersensitivity31
7Sinus congestion28
8Nasal congestion23
9Bronchitis20
10Rhinorrhoea10

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


Types of Adverse Events for DIMETAPP

Total Reports Filed with FDA: 1184


Number of FDA Adverse Event Reports by Patient Age for DIMETAPP

Total Reports Filed with FDA: 1184*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Brompheniramine maleate; phenylpropanolamine hydrochloride (Bromatapp, Biphetap, Bromanate, Dimetapp)

Charts are based on 1184 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 DIMETAPP Reviews and Review Summary .

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.

Visit   DrugInformer.com more on DIMETAPP's side effects.