Drug Safety Information for NAPROXEN (Naproxen)

FDA Safety Communication for ALEVE (NAPROXEN SODIUM) Over-the-counter Drug: FDA Link

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid; NSAIDs may cause rare kidney problems in unborn babies

Safety-related Labeling Changes for ALEVE (NAPROXEN SODIUM) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for NAPRELAN (NAPROXEN SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for ALEVE-D SINUS & COLD (NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for TREXIMET (NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE) Rx Drug: FDA Link

Safety-related Labeling Changes for NAPROSYN (NAPROXEN) Rx Drug: FDA Link

Safety-related Labeling Changes for ANAPROX (NAPROXEN SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for EC-NAPROSYN (NAPROXEN) Rx Drug: FDA Link

Adverse Drug Reactions for NAPROXEN* (Naproxen)

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 NAPROXEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain1880
2Nausea*1525
3Dyspnoea1337
4Headache1129
5Drug ineffective*1123
6Fatigue1118
7Arthralgia1064
8Anxiety1064
9Dizziness*1032
10Vomiting*980
11Diarrhoea948
12Pain in extremity942
13Depression894
14Chest pain856
15Injury761
16Asthenia751
17Back pain747
18Abdominal pain740
19Pulmonary embolism712
20Fall688

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

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

Reason # of FDA Reports
1Product used for unknown indication14229
2Pain*7802
3Arthritis*3388
4Rheumatoid arthritis2986
5Arthralgia*2322
6Back pain*1942
7Osteoarthritis*1663
8Headache978
9Inflammation925
10Premedication708

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


Types of Adverse Events for NAPROXEN

Total Reports Filed with FDA: 128755


Number of FDA Adverse Event Reports by Patient Age for NAPROXEN

Total Reports Filed with FDA: 128755*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Naproxen (Proxen, Synflex, Ec-naprosyn, Naprosin, Naproxen tablets, Aleve cold and sinus, Naprosyn, Naproxen)

Charts are based on 128755 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 NAPROXEN Reviews and Review Summary .

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.

Visit   DrugInformer.com more on NAPROXEN's side effects.