Drug Safety Information for MEPERGAN (Meperidine hydrochloride; promethazine hydrochloride)

Safety-related Labeling Changes for MEPERGAN (MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for MEPERGAN* (Meperidine 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 MEPERGAN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea13
2Vomiting10
3Fatigue9
4Pain*9
5Oedema peripheral8
6Abdominal pain upper8
7Back pain8
8Depression7
9Dehydration7
10Anxiety7
11Pain in extremity7
12Headache7
13Injury7
14Insomnia6
15Deep vein thrombosis6
16Pulmonary embolism6
17Cholelithiasis6
18Chest pain5
19Abdominal pain5
20Emotional distress5

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

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

Reason # of FDA Reports
1Pain27
2Product used for unknown indication26
3Migraine17
4Headache9

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


Types of Adverse Events for MEPERGAN

Total Reports Filed with FDA: 854


Number of FDA Adverse Event Reports by Patient Age for MEPERGAN

Total Reports Filed with FDA: 854*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Meperidine hydrochloride; promethazine hydrochloride (Mepergan)

Charts are based on 854 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 MEPERGAN 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.