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Naproxen Adverse Events Reported to the FDA Over Time

How are Naproxen adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Naproxen, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Naproxen is flagged as the suspect drug causing the adverse event.

Most Common Naproxen Adverse Events Reported to the FDA

What are the most common Naproxen adverse events reported to the FDA?

No Adverse Event
5263 (7.17%)
Headache
2388 (3.25%)
Drug Ineffective
2307 (3.14%)
Pain
1484 (2.02%)
Nausea
1357 (1.85%)
Dizziness
1215 (1.65%)
Hypersensitivity
1097 (1.49%)
Abdominal Pain Upper
1048 (1.43%)
Pruritus
918 (1.25%)
Arthralgia
897 (1.22%)
Back Pain
890 (1.21%)
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Dyspnoea
875 (1.19%)
Vomiting
822 (1.12%)
Urticaria
755 (1.03%)
Somnolence
731 (1%)
Abdominal Discomfort
682 (.93%)
Feeling Abnormal
640 (.87%)
Blood Pressure Increased
627 (.85%)
Dysmenorrhoea
604 (.82%)
Diarrhoea
589 (.8%)
Oedema Peripheral
574 (.78%)
Rash
572 (.78%)
Insomnia
562 (.77%)
Dyspepsia
518 (.71%)
Swelling Face
513 (.7%)
Fatigue
491 (.67%)
Pain In Extremity
489 (.67%)
Chest Pain
462 (.63%)
Asthenia
458 (.62%)
Erythema
450 (.61%)
Abdominal Pain
447 (.61%)
Constipation
424 (.58%)
Completed Suicide
419 (.57%)
Malaise
397 (.54%)
Haematochezia
389 (.53%)
Gastrointestinal Haemorrhage
386 (.53%)
Loss Of Consciousness
378 (.51%)
Lip Swelling
339 (.46%)
Muscle Spasms
321 (.44%)
Euphoric Mood
310 (.42%)
Gastric Ulcer
308 (.42%)
Faeces Discoloured
302 (.41%)
Renal Failure Acute
287 (.39%)
Haematemesis
286 (.39%)
Rectal Haemorrhage
286 (.39%)
Pruritus Generalised
280 (.38%)
Palpitations
268 (.36%)
Pyrexia
264 (.36%)
Arthritis
260 (.35%)
Paraesthesia
260 (.35%)
Anaemia
252 (.34%)
Hypoaesthesia
251 (.34%)
Haemoglobin Decreased
250 (.34%)
Hyperhidrosis
248 (.34%)
Hypotension
241 (.33%)
Throat Irritation
241 (.33%)
Heart Rate Increased
239 (.33%)
Migraine
238 (.32%)
Eye Swelling
234 (.32%)
Haemorrhage
231 (.31%)
Toothache
228 (.31%)
Burning Sensation
225 (.31%)
Tremor
225 (.31%)
Contusion
222 (.3%)
Gastric Haemorrhage
219 (.3%)
Swollen Tongue
215 (.29%)
Chest Discomfort
214 (.29%)
Overdose
213 (.29%)
Anxiety
207 (.28%)
Drug Hypersensitivity
206 (.28%)
Feeling Hot
205 (.28%)
Hypertension
205 (.28%)
Abdominal Distension
201 (.27%)
Vision Blurred
200 (.27%)
Epistaxis
195 (.27%)
Swelling
191 (.26%)
Unevaluable Event
186 (.25%)
Syncope
184 (.25%)
Myalgia
182 (.25%)
Musculoskeletal Pain
180 (.25%)
Nervousness
176 (.24%)
Dysphagia
167 (.23%)
Anaphylactic Reaction
166 (.23%)
Neck Pain
166 (.23%)
Throat Tightness
165 (.22%)
Melaena
163 (.22%)
Cardiac Arrest
159 (.22%)
Rash Macular
158 (.22%)
Respiratory Arrest
158 (.22%)
Drug Toxicity
155 (.21%)
Pharyngeal Oedema
155 (.21%)
Joint Swelling
153 (.21%)
Blister
152 (.21%)
Blood Urine Present
151 (.21%)
Confusional State
149 (.2%)
Fall
147 (.2%)
Blood Glucose Increased
146 (.2%)
Renal Failure
143 (.19%)
Death
142 (.19%)
Weight Increased
142 (.19%)
Anaphylactic Shock
140 (.19%)

ExportShare/Embed GraphExport Export Data

This graph shows the top adverse events submitted to the FDA for Naproxen, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Naproxen is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Naproxen

What are the most common Naproxen adverse events reported to the FDA?

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ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Naproxen, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Naproxen is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Naproxen According to Those Reporting Adverse Events

Why are people taking Naproxen, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
4381
Pain
3204
Headache
3125
Drug Use For Unknown Indication
3031
Arthralgia
2576
Back Pain
2552
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Arthritis
2483
Dysmenorrhoea
1051
Analgesic Therapy
895
Migraine
867
Rheumatoid Arthritis
828
Osteoarthritis
649
Pain In Extremity
586
Toothache
549
Myalgia
395
Musculoskeletal Pain
362
Nasopharyngitis
327
Premedication
222
Neck Pain
203
Inflammation
200
Analgesia
192
Muscle Spasms
181
Accidental Drug Intake By Child
179
Pyrexia
125
Sciatica
117
Procedural Pain
105
Sinus Headache
100
Antiinflammatory Therapy
98
Juvenile Arthritis
98
Fibromyalgia
92
Gout
92
Accidental Exposure
92
Suicide Attempt
82
Muscle Strain
78
Tendonitis
69
Abdominal Pain Upper
67
Abdominal Pain
58
Analgesic Effect
55
Psoriatic Arthropathy
53
Ill-defined Disorder
51
Cancer Pain
48
Chest Pain
47
Back Disorder
46
Ankylosing Spondylitis
45
Prophylaxis
44
Swelling
42
Musculoskeletal Stiffness
42
Nerve Compression
42
Bone Pain
42
Bursitis
41
Joint Swelling
41

Drug Labels

LabelLabelerEffective
Good Sense All Day Pain ReliefBryant Ranch Prepack14-JAN-97
Naproxen SodiumBryant Ranch Prepack26-APR-07
NaproxenMylan Pharmaceuticals Inc.15-MAY-08
NaproxenPD-Rx Pharmaceuticals, Inc.15-MAY-08
Naproxen Sodiumall Day Pain ReliefRite Aid Corporation22-MAY-09
Naproxen Sodiumbryant ranch prepack30-JUL-09
NaprelanVictory Pharma, Inc. 01-AUG-09
NaprelanPD-Rx Pharmaceuticals, Inc.01-AUG-09
NaprelanPhysicians Total Care, Inc.01-AUG-09
Naproxen Tablets Dr. Reddy's Laboratories Limited01-SEP-09
Formucare Naproxen Sodiumpain Reliever Fever ReducerAccess Business Group International LLC29-SEP-09
Naproxen Sodium AvKARE, Inc.13-OCT-09
Naproxen SodiumBlenheim Pharmacal, Inc.30-NOV-09
NaproxenRebel Distributors Corp.18-FEB-10
NaprelanSTAT RX USA 15-MAR-10
NaproxenContract Pharmacy Services-PA19-MAR-10
NaproxenBlenheim Pharmacal, Inc.21-APR-10
Naproxen SodiumBlenheim Pharmacal, Inc.21-APR-10
NaproxenAltura Pharmaceuticals, Inc.27-APR-10
Naproxen SodiumAltura Pharmaceuticals, Inc.27-APR-10
Naproxen SodiumState of Florida DOH Central Pharmacy07-JUN-10
NaproxenState of Florida DOH Central Pharmacy07-JUN-10
NaproxenState of Florida DOH Central Pharmacy07-JUN-10
NaproxenState of Florida DOH Central Pharmacy07-JUN-10
Naproxen Sodium (nsaid)fever Reducer/ Pain RelieverAmneal Pharmaceuticals16-JUL-10
Naproxen SodiumPhysicians Total Care, Inc.16-JUL-10
Naproxen PD-Rx Pharmaceuticals, Inc.17-SEP-10
Naproxen PD-Rx Pharmaceuticals, Inc.17-SEP-10
Naproxen PD-Rx Pharmaceuticals, Inc.17-SEP-10
NaproxenAmneal Pharmaceuticals17-SEP-10
Naproxen Unit Dose Services17-SEP-10
Naproxen PD-Rx Pharmaceuticals, Inc.17-SEP-10
Naproxen SodiumAmneal Pharmaceuticals22-SEP-10
Naproxen Sodium PD-Rx Pharmaceuticals, Inc.22-SEP-10
Naproxen Sodium Unit Dose Services22-SEP-10
NaproxenPD-Rx Pharmaceuticals, Inc.23-SEP-10
Smart Sense Naproxen SodiumKmart Corporation01-OCT-10
NaproxenKeltman Pharmaceuticals Inc.04-OCT-10
NaproxenBlenheim Pharmacal, Inc.06-OCT-10
NaproxenBlenheim Pharmacal, Inc.13-OCT-10
Naproxen SodiumDr.Reddy's Laboratories Limited15-NOV-10
Naproxen SodiumKeltman Pharmaceuticals Inc.10-DEC-10
Naproxen SodiumHyVee Inc10-DEC-10
NaprelanRebel Distributors Corp29-DEC-10
Naproxen SodiumRebel Distributors Corp03-JAN-11
Rx Act Naproxen SodiumH E B04-JAN-11
Naproxen SodiumMeijer Distribution Inc14-JAN-11
NaproxenRebel Distributors Corp17-JAN-11
NaproxenLake Erie Medical DBA Quality Care Products LLC17-JAN-11
NaproxenPreferred Pharmaceuticals, Inc25-JAN-11
NaproxenUnit Dose Services25-JAN-11
NaproxenPD-Rx Pharmaceuticals, Inc.25-JAN-11
NaproxenWest-ward Pharmaceutical Corp25-JAN-11
Naproxen SodiumGlenmark Generics Inc., USA25-JAN-11
Naproxen SodiumPD-Rx Pharmaceuticals, Inc.25-JAN-11
NaproxenPD-Rx Pharmaceuticals, Inc.25-JAN-11
NaproxenGlenmark Generics Inc., USA25-JAN-11
NaproxenMajor Pharmaceuticals11-FEB-11
Naproxen Pain ReliefRebel Distributors Corp23-FEB-11
NaproxenREMEDYREPACK INC. 08-MAR-11
Naproxen SodiumMajor Pharmaceuticals02-APR-11
Naproxen SodiumHikma Pharmaceutical06-MAY-11
NaproxenREMEDYREPACK INC. 13-MAY-11
NaproxenCardinal Health18-MAY-11
Naproxen SodiumMarksans Pharma Limited01-JUN-11
NaproxenBlenheim Pharmacal, Inc.02-JUN-11
Naproxen SodiumREMEDYREPACK INC. 09-JUN-11
Naproxen Sodium Preferred Pharmaceuticals, Inc14-JUN-11
NaproxenREMEDYREPACK INC. 28-JUN-11
NaproxenGolden State Medical Supply, Inc.01-JUL-11
VimovoSTAT RX USA LLC29-JUL-11
Naproxen SodiumSPIRIT PHARMACEUTICALS,LLC03-AUG-11
NaproxenPhysicians Total Care, Inc.17-AUG-11
NaproxenREMEDYREPACK INC. 30-AUG-11
TreximetRebel Distributors Corp13-SEP-11
NaproxenH.J. Harkins Company, Inc.12-OCT-11
NaproxenSandoz Inc21-OCT-11
NaproxenH.J. Harkins Company, Inc.27-OCT-11
Naproxen SodiumAurobindo Pharma Limited02-NOV-11
Naproxen SodiumREMEDYREPACK INC. 03-NOV-11
NaproxenNCS HealthCare of KY, Inc dba Vangard Labs09-NOV-11
NaproxenAurobindo Pharma Limited14-NOV-11
Health Mart Naproxen SodiumMcKesson28-NOV-11
NaprelanLake Erie Medical & Surgical Supply DBA Quality Care Products LLC29-NOV-11
NaproxenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC01-DEC-11
Naproxen SodiumGranules India Limited05-DEC-11
Naproxen Lake Erie Medical DBA Quality Care Products LLC06-DEC-11
Naproxen SodiumRite Aid Corporation08-DEC-11
NaproxenREMEDYREPACK INC. 12-JAN-12
NaproxenPreferred Pharmaceuticals, Inc30-JAN-12
NaproxenRoxane Laboratories, Inc30-JAN-12
NaproxenCamber Pharmaceuticals31-JAN-12
Naproxendelayed ReleaseCamber Pharmaceuticals01-FEB-12
NaproxenEpic Pharma, LLC21-FEB-12
NaproxenEpic Pharma, LLC21-FEB-12
NaproxenLife Line Home Care Services, Inc.23-FEB-12
NaproxenSTAT Rx USA LLC24-FEB-12
Naproxen SodiumSTAT Rx USA LLC24-FEB-12
NaproxenMcKesson Contract Packaging27-FEB-12
NaproxenRebel Distributors Corp06-MAR-12
Naproxen SodiumPreferred Pharmaceuticals, Inc12-MAR-12
Good Neighbor Pharmacy Naproxen SodiumAmerisource Bergen19-MAR-12
Simply Right Naproxen SodiumSam's West Inc20-MAR-12
Naproxen Sodium H.J. Harkins Company, Inc.18-APR-12
NaproxenSTAT Rx USA LLC25-APR-12
NaproxenCardinal Health01-MAY-12
NaproxenNCS HealthCare of KY, Inc dba Vangard Labs08-MAY-12
NaproxenRebel Distributors Corp08-MAY-12
Good Neighbor Pharmacy Pain Reliefall DayAmerisource Bergen19-JUN-12
Members Mark Naproxen SodiumSam's West Inc19-JUN-12
Naproxen SodiumLake Erie Medical & Surgical Supply DBA Quality Care Products LLC27-JUN-12
NaproxenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-JUL-12
NaproxenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-JUL-12
Naproxen SodiumTeva Pharmaceuticals USA Inc30-JUL-12
NaproxenSTAT Rx USA LLC31-JUL-12
NaproxenSTAT Rx USA LLC31-JUL-12
NaproxenSTAT Rx USA LLC02-AUG-12
NaproxenTeva Pharmaceuticals USA Inc06-AUG-12
Naproxen SodiumSTAT Rx USA LLC10-AUG-12
Naproxen SodiumRugby Laboratories Inc15-AUG-12
NaproxenAidarex Pharmaceuticals LLC30-AUG-12
NaproxenREMEDYREPACK INC. 04-SEP-12
Naproxen SodiumPhysicians Total Care, Inc.11-SEP-12
NaproxenPolygen Pharmaceuticals LLC14-SEP-12
NaproxenMajor Pharmaceuticals26-SEP-12
VimovoAstraZeneca LP09-OCT-12
Naproxen Sodium AvPAK11-OCT-12
NaproxenBryant Ranch Prepack12-OCT-12
Naproxen SodiumBryant Ranch Prepack12-OCT-12
NaproxenBryant Ranch Prepack12-OCT-12
NaproxenBryant Ranch Prepack23-OCT-12
NaproxenLiberty Pharmaceuticals, Inc.23-OCT-12
TreximetGlaxoSmithKline LLC07-NOV-12
Naproxen Sodium Polygen Pharmaceuticals LLC13-NOV-12
NaproxenTeva Pharmaceuticals USA Inc07-DEC-12
Kirkland Signature Naproxen SodiumCostco Wholesale Company10-DEC-12
Equate Naproxen SodiumWal-Mart Stores Inc10-DEC-12
Smart Sense Naproxen SodiumKmart Corporation11-DEC-12
Exchange Select Naproxen SodiumArmy & Air Force Exchange Service11-DEC-12
Up And Up Naproxen SodiumTarget Corporation11-DEC-12
Healthy Accents Naproxen SodiumDZA Brands LLC19-DEC-12
Naproxen SodiumRite Aid Corporation19-DEC-12
Naproxen SodiumAAA Pharmaceutical, Inc.26-DEC-12
NaproxenREMEDYREPACK INC. 28-DEC-12
Naproxen Sodium AAA Pharmaceutical, Inc.04-JAN-13
NaproxenREMEDYREPACK INC. 10-JAN-13
NaprelanBryant Ranch Prepack18-JAN-13
Naproxen SodiumCVS Pharmacy27-FEB-13
Healthy Accents Naproxen SodiumDZA Brands LLC27-FEB-13
Smart Sense Naproxen SodiumKmart Corporation27-FEB-13
Sunmark Naproxen SodiumMcKesson27-FEB-13
Dg Health Naproxen SodiumDolgencorp, LLC27-FEB-13
Equaline Naproxen SodiumSupervalu Inc27-FEB-13
Health Mart Naproxen SodiumMcKesson27-FEB-13
Up And Up Naproxen SodiumTarget Corporation27-FEB-13
Topcare Naproxen SodiumTopco Associates LLC28-FEB-13
Careone Naproxen SodiumAmerican Sales Company28-FEB-13
Good Sense Naproxen SodiumL. Perrigo Company28-FEB-13
Naproxen SodiumSafeway28-FEB-13
Naproxen SodiumRite Aid Corporation28-FEB-13
Leader Naproxen SodiumCardinal Health28-FEB-13
Naproxen SodiumWalgreen Company28-FEB-13
NaproxenREMEDYREPACK INC. 01-MAR-13
Good Neighbor Pharmacy Naproxen SodiumAmerisource Bergen01-MAR-13
Equate Naproxen SodiumWal-Mart Stores Inc01-MAR-13
Naproxen SodiumWestern Family Foods Inc01-MAR-13
Naproxen SodiumKroger Company01-MAR-13
Naproxen SodiumH E B04-MAR-13
Berkley And Jensen Naproxen SodiumBJWC05-MAR-13
Equate Naproxen SodiumWal-Mart Stores Inc08-MAR-13
Smart Sense Naproxen SodiumKmart Corporation08-MAR-13
Up And Up Naproxen SodiumTarget Corporation08-MAR-13
Careall NaproxenNew World Imports, Inc.15-MAR-13
AnaproxGenentech, Inc.05-APR-13
Ec-naprosynGenentech, Inc.05-APR-13
Anaprox DsGenentech, Inc.05-APR-13
NaprosynGenentech, Inc.05-APR-13
NaproxenWest-Ward Pharmaceutical Corp10-APR-13
NaproxenMARKSANS PHARMA LIMITED15-APR-13
NaproxenPolygen Pharmaceuticals LLC25-APR-13

Naproxen Case Reports

What Naproxen safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Naproxen. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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