Drug Safety Information for OXYCODONE HYDROCHLORIDE AND IBUPROFEN (Ibuprofen; oxycodone hydrochloride)

Adverse Drug Reactions for OXYCODONE HYDROCHLORIDE AND IBUPROFEN* (Ibuprofen; 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 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Depression4
2Drug ineffective3
3Pain3
4Anxiety3
5Myalgia2
6Nausea2
7Tendon rupture2
8Cholecystitis chronic2
9Rash generalised2
10Gun shot wound2
11Swelling face2
12Skin lesion2
13Abdominal distension2
14Deep vein thrombosis2
15Blood pressure increased2
16Nightmare2
17Rectal haemorrhage2
18Arthralgia2
19Panic attack2
20Constipation2

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

Top 10 Reasons for Taking OXYCODONE HYDROCHLORIDE AND IBUPROFEN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Pain59
2Back pain40
3Spondylitis1

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


Types of Adverse Events for OXYCODONE HYDROCHLORIDE AND IBUPROFEN

Total Reports Filed with FDA: 166


Number of FDA Adverse Event Reports by Patient Age for OXYCODONE HYDROCHLORIDE AND IBUPROFEN

Total Reports Filed with FDA: 166*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ibuprofen; oxycodone hydrochloride (Combunox)

Charts are based on 166 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 OXYCODONE HYDROCHLORIDE AND IBUPROFEN 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.