Drug Safety Information for DEMEROL (Meperidine hydrochloride)

FDA Safety-related Labeling Changes for DEMEROL (MEPERIDINE HYDROCHLORIDE) Rx Drug: Safety Information Link

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

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

  Side Effect # of FDA Reports
1Drug hypersensitivity508
2Pain397
3Nausea*390
4Vomiting*304
5Dyspnoea281
6Anxiety*256
7Headache215
8Pyrexia209
9Abdominal pain207
10Diarrhoea204
11Chest pain196
12Injury194
13Hypotension188
14Drug ineffective181
15Back pain174
16Fatigue173
17Dizziness*171
18Asthenia169
19Depression169
20Fall159

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

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

Reason # of FDA Reports
1Pain2749
2Product used for unknown indication2703
3Migraine*317
4Chills282
5Analgesic therapy201
6Premedication148
7Abdominal pain140
8Sedation139
9Back pain123
10Colonoscopy*116

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


Types of Adverse Events for DEMEROL

Total Reports Filed with FDA: 34295


Number of FDA Adverse Event Reports by Patient Age for DEMEROL

Total Reports Filed with FDA: 34295*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Meperidine hydrochloride (Meperidine, Pethidine, Demerol, Meperidine hcl)

Charts are based on 34295 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 DEMEROL 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.