Drug Safety Information for CHLOR-TRIMETON (Chlorpheniramine maleate)

FDA Safety-related Labeling Changes for ADVIL ALLERGY SINUS (CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE) Over-the-counter Drug: Safety Information Link

FDA Safety-related Labeling Changes for ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE) Over-the-counter Drug: Safety Information Link

FDA Safety-related Labeling Changes for ZUTRIPRO (CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for VITUZ (CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE) Discontinued Drug: Safety Information Link

FDA Safety-related Labeling Changes for CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for CHLOR-TRIMETON* (Chlorpheniramine maleate)

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 CHLOR-TRIMETON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia253
2Dyspnoea*223
3Toxicity to various agents178
4Nausea164
5Diarrhoea159
6Rash158
7Vomiting150
8Malaise137
9Febrile neutropenia137
10Death135
11Infusion related reaction130
12Headache126
13Pruritus*115
14Pneumonia113
15Drug ineffective*110
16Tachycardia107
17Fatigue*105
18Dizziness100
19Hypotension98
20Neutropenia97

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

Top 10 Reasons for Taking CHLOR-TRIMETON
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2423
2Premedication1261
3Hypersensitivity705
4Prophylaxis655
5Pruritus401
6Chronic lymphocytic leukaemia173
7Rash157
8Allergy prophylaxis137
9Seasonal allergy*127
10Nasopharyngitis123

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


Types of Adverse Events for CHLOR-TRIMETON

Total Reports Filed with FDA: 17610


Number of FDA Adverse Event Reports by Patient Age for CHLOR-TRIMETON

Total Reports Filed with FDA: 17610*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Chlorpheniramine maleate (Phenetron, Kloromin, Aller-chlor, Antagonate, Chlortab, Pyridamal 100, Allergy time, Ed chlorped, Good sense allergy, Medique chlorphen, Sun mark allergy, Topcare allergy, Equaline allergy, Anti allergy, Ed chlorped jr, Ed-chlortan, Chlor-trimeton 4hour, Wal-finite, Chlorphenamine, Chlorpheniramine, Chlor-tabs, Chlor-trimeton, Teldrin)

Charts are based on 17610 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 CHLOR-TRIMETON 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.