Drug Safety Information for ALEVE (Naproxen sodium)
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 ANAPROX (NAPROXEN SODIUM) Rx Drug: FDA Link
Adverse Drug Reactions for ALEVE* (Naproxen sodium)
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 ALEVE
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug ineffective | 6936 |
2 | Headache | 2928 |
3 | Pain* | 2172 |
4 | Incorrect drug administration duration | 2013 |
5 | Nausea | 1842 |
6 | Dizziness | 1488 |
7 | Abdominal pain upper | 1312 |
8 | Arthralgia | 1235 |
9 | Abdominal discomfort | 1161 |
10 | Back pain | 1154 |
11 | Pruritus* | 1107 |
12 | Dyspnoea* | 1094 |
13 | Fatigue | 1065 |
14 | Hypersensitivity* | 1042 |
15 | Vomiting | 1022 |
16 | Diarrhoea | 883 |
17 | Somnolence | 870 |
18 | Urticaria* | 836 |
19 | Pain in extremity | 830 |
20 | Insomnia | 812 |
* This side effect also appears in "Top 10 Side Effects of ALEVE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ALEVE
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Product used for unknown indication | 12601 |
2 | Pain* | 7611 |
3 | Headache* | 6630 |
4 | Arthritis* | 6625 |
5 | Back pain* | 6310 |
6 | Arthralgia* | 5301 |
7 | Analgesic therapy | 3571 |
8 | Dysmenorrhoea* | 1630 |
9 | Toothache | 1279 |
10 | Pain in extremity | 1201 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ALEVE
Total Reports Filed with FDA: 115607
Number of FDA Adverse Event Reports by Patient Age for ALEVE
Total Reports Filed with FDA: 115607*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Naproxen sodium (All day relief, Medique mediproxen, Naproxen pain relief, Aleve, Flanax pain reliever, Bayer aleve, Careall naproxen, Modern pain medicine, Anaprox ds, All day pain relief, Anaprox, Naprelan, Naproxen sodium)
Charts are based on 115607 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 ALEVE 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.