Drug Safety Information for CONTAC (Chlorpheniramine maleate; phenylpropanolamine hydrochloride)

Adverse Drug Reactions for CONTAC* (Chlorpheniramine 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 CONTAC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Cerebrovascular accident32
2Headache16
3Hemiparesis13
4Injury13
5Amnesia12
6Convulsion11
7Blood pressure increased11
8Nausea11
9Hypoaesthesia11
10Dysarthria10
11Dizziness10
12Myocardial infarction9
13Pain9
14Drug ineffective9
15Anxiety*8
16Ischaemic stroke8
17Insomnia8
18Hypertension8
19Fatigue8
20Haemorrhagic stroke8

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

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

Reason # of FDA Reports
1Nasopharyngitis113
2Product used for unknown indication50
3Influenza30
4Hypersensitivity26
5Rhinorrhoea17
6Seasonal allergy16
7Sinus disorder12
8Cough9
9Nasal congestion6
10Sinusitis4

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


Types of Adverse Events for CONTAC

Total Reports Filed with FDA: 961


Number of FDA Adverse Event Reports by Patient Age for CONTAC

Total Reports Filed with FDA: 961*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Chlorpheniramine maleate; phenylpropanolamine hydrochloride (Cold capsule iv, Cold capsule v, Drize, Ornade, Contac 12 hour, Triaminic-12, Demazin, Contac)

Charts are based on 961 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 CONTAC 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.