Drug Safety Information for PHENERGAN VC (Phenylephrine hydrochloride; promethazine hydrochloride)

Adverse Drug Reactions for PHENERGAN VC* (Phenylephrine hydrochloride; promethazine 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 PHENERGAN VC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain8
2Nausea6
3Oedema peripheral5
4Cardiac failure congestive5
5Hyperhidrosis4
6Dyspnoea4
7Pain in extremity4
8Weight increased4
9Cholecystitis3
10Dizziness3
11Sinusitis3
12Bronchitis3
13Depression3
14Anaemia3
15Pneumonia3
16Convulsion3
17Amnesia3
18Anxiety3
19Fall3
20Abdominal distension3

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

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

Reason # of FDA Reports
1Product used for unknown indication23
2Hypersensitivity1

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


Types of Adverse Events for PHENERGAN VC

Total Reports Filed with FDA: 387


Number of FDA Adverse Event Reports by Patient Age for PHENERGAN VC

Total Reports Filed with FDA: 387*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Phenylephrine hydrochloride; promethazine hydrochloride (Pherazine vc, Promethazine vc, Prometh vc plain, Phenergan vc)

Charts are based on 387 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 PHENERGAN VC 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.