Drug Safety Information for BROMFED-DM (Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride)

Adverse Drug Reactions for BROMFED-DM* (Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine 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 BROMFED-DM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia23
2Pain21
3Condition aggravated20
4Dyspnoea20
5Headache18
6Pneumonia15
7Death14
8Injury14
9Anxiety14
10Drug ineffective13
11Vomiting13
12Asthenia13
13Malaise13
14Renal failure12
15Pleural effusion12
16Nausea12
17Cardiac failure11
18Oedema peripheral11
19Emotional distress10
20Renal impairment10

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

Top 10 Reasons for Taking BROMFED-DM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication181
2Eustachian tube dysfunction92
3Hyperthyroidism56
4Parkinson's disease47
5Cerebrovascular accident34
6Nasal congestion29
7Anaemia27
8Depression21
9Cough19
10Gastritis18

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


Types of Adverse Events for BROMFED-DM

Total Reports Filed with FDA: 1990


Number of FDA Adverse Event Reports by Patient Age for BROMFED-DM

Total Reports Filed with FDA: 1990*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride (Dimetane-dx, Bromfed-dm, Bromanate dm, Neo, Bio dtuss, Brom/pse/dm, Brovex psb dm, Endacof pd, Lohist psb dm, Q-tapp dm elixir, Bromfeddm, Bromfed)

Charts are based on 1990 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 BROMFED-DM 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.

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