Drug Safety Information for DAYPRO (Oxaprozin)

FDA Safety-related Labeling Changes for DAYPRO (OXAPROZIN) Rx Drug: Safety Information Link

Adverse Drug Reactions for DAYPRO* (Oxaprozin)

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 DAYPRO
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug hypersensitivity	128
2	Pain	101
3	Drug ineffective*	97
4	Nausea	84
5	Dyspnoea	73
6	Fatigue*	65
7	Arthralgia	64
8	Headache	64
9	Depression	60
10	Chest pain	59
11	Dizziness	59
12	Pain in extremity	58
13	Back pain	56
14	Hypertension	56
15	Anxiety	54
16	Vomiting	52
17	Oedema peripheral	52
18	Fall	50
19	Asthenia	49
20	Diarrhoea	48

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

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

	Reason	# of FDA Reports
1	Arthritis	378
2	Product used for unknown indication	329
3	Back pain*	212
4	Pain	201
5	Rheumatoid arthritis*	184
6	Osteoarthritis*	128
7	Arthralgia*	128
8	Inflammation	93
9	Antiinflammatory therapy	43
10	Ill-defined disorder	39

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

Types of Adverse Events for DAYPRO

Total Reports Filed with FDA: 7766

Number of FDA Adverse Event Reports by Patient Age for DAYPRO

Total Reports Filed with FDA: 7766*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxaprozin (Daypro, Oxaprozin)

Charts are based on 7766 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.

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.