Drug Safety Information for PERCOCET (Acetaminophen; oxycodone hydrochloride)

Safety-related Labeling Changes for XARTEMIS XR (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for PERCOCET* (Acetaminophen; oxycodone 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 PERCOCET
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain2710
2Nausea*2431
3Drug ineffective1873
4Fatigue1673
5Dyspnoea1602
6Vomiting1583
7Headache*1463
8Anxiety1452
9Diarrhoea1362
10Asthenia1234
11Dizziness*1212
12Depression1200
13Back pain1172
14Fall1111
15Arthralgia1091
16Pain in extremity1063
17Abdominal pain1021
18Chest pain998
19Pneumonia937
20Insomnia*920

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

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

Reason # of FDA Reports
1Pain*25044
2Product used for unknown indication13871
3Breakthrough pain3250
4Back pain*3130
5Arthralgia904
6Headache464
7Fibromyalgia*458
8Procedural pain427
9Rheumatoid arthritis405
10Pain management393

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


Types of Adverse Events for PERCOCET

Total Reports Filed with FDA: 167956


Number of FDA Adverse Event Reports by Patient Age for PERCOCET

Total Reports Filed with FDA: 167956*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Acetaminophen; oxycodone hydrochloride (Roxilox, Roxicet 5/500, Tylox-325, Oxycet, Xolox, Oxycodone 5/apap 500, Primlev, Xartemis, Endocet, Roxicet, Xartemis xr, Magnacet, Tylox, Percocet)

Charts are based on 167956 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 PERCOCET 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.