NAPROXEN

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%)

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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?

Gastrointestinal Signs	6027 (8.21%)
Epidermal And Dermal Conditions	4276 (5.82%)
Neurological	4175 (5.69%)
Therapeutic And Nontherapeutic Effe...	2918 (3.97%)
Headaches	2702 (3.68%)
Respiratory	2336 (3.18%)
Musculoskeletal And Connective Tiss...	2110 (2.87%)
Gastrointestinal Hemorrhages	1913 (2.61%)
Allergic Conditions	1647 (2.24%)
Joint	1565 (2.13%)
Cardiac And Vascular Investigations	1391 (1.89%)
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Gastrointestinal Motility And Defec...	1287 (1.75%)
Gastrointestinal Ulceration And Per...	1079 (1.47%)
Oral Soft Tissue Conditions	922 (1.26%)
Medication Errors	874 (1.19%)
Angiedema And Urticaria	853 (1.16%)
Muscle	804 (1.09%)
Sleep Disorders	799 (1.09%)
Infections - Pathogen Unspecified	778 (1.06%)
Renal Disorders	764 (1.04%)
Injuries	720 (.98%)
Menstrual Cycle And Uterine Bleedin...	696 (.95%)
Hematology Investigations	646 (.88%)
Cardiac Arrhythmias	623 (.85%)
Suicidal And Self-injurious Behavio...	600 (.82%)
Anxiety Disorders	571 (.78%)
Upper Respiratory Tract Disorders	560 (.76%)
Urinary Tract Signs	513 (.7%)
Renal And Urinary Tract Investigati...	434 (.59%)
Skin Appendage Conditions	418 (.57%)
Movement Disorders	413 (.56%)
Electrolyte And Fluid Balance Condi...	411 (.56%)
Hepatic And Hepatobiliary	405 (.55%)
Mood Disorders	399 (.54%)
Vision	391 (.53%)
Physical Examination Topics	382 (.52%)
Anemias Nonhemolytic And Marrow Dep...	380 (.52%)
Tongue Conditions	379 (.52%)
Eye	377 (.51%)
Cardiac Disorder Signs	364 (.5%)
Decreased And Nonspecific Blood Pre...	361 (.49%)
Chemical Injury And Poisoning	351 (.48%)
Coronary Artery	304 (.41%)
Gastrointestinal Inflammatory Condi...	301 (.41%)
Central Nervous System Vascular	298 (.41%)
Vascular	297 (.4%)
Dental And Gingival Conditions	279 (.38%)
Body Temperature Conditions	273 (.37%)
Vascular Hemorrhagic	271 (.37%)
Ocular Infections, Irritations And ...	269 (.37%)
Bronchial Disorders	268 (.36%)
Gastrointestinal Conditions	258 (.35%)
Metabolic, Nutritional And Blood Ga...	256 (.35%)
Tissue	253 (.34%)
Psychiatric	246 (.34%)
Deliria	241 (.33%)
Vascular Hypertensive	219 (.3%)
Hepatobiliary	208 (.28%)
Inner Ear And Viiith Cranial Nerve	203 (.28%)
Mental Impairment	198 (.27%)
Lifestyle Issues	185 (.25%)
Appetite And General Nutritional	184 (.25%)
Water, Electrolyte And Mineral	184 (.25%)
Fatal Outcomes	164 (.22%)
Bone Disorders	147 (.2%)
Seizures	145 (.2%)
Toxicology And Therapeutic Drug Mon...	143 (.19%)
Bacterial Infectious	142 (.19%)
Procedural And Device Related Injur...	140 (.19%)
Skin Vascular Abnormalities	140 (.19%)
Salivary Gland Conditions	137 (.19%)
Depressed Mood Disorders	132 (.18%)
Viral Infectious	118 (.16%)
Disturbances In Thinking	108 (.15%)
Lower Respiratory Tract Disorders	106 (.14%)
Lipid Analyses	101 (.14%)
Therapeutic Procedures And Supporti...	96 (.13%)
Gastrointestinal Stenosis And Obstr...	95 (.13%)
Heart Failures	93 (.13%)
Embolism And Thrombosis	91 (.12%)
Vulvovaginal Disorders	90 (.12%)
Nephropathies	88 (.12%)
Platelet	85 (.12%)
Bone And Joint Injuries	84 (.11%)
Sleep Disturbances	84 (.11%)
Hematological And Lymphoid Tissue T...	81 (.11%)
Aural	80 (.11%)
Product Quality Issues	75 (.1%)
Glucose Metabolism Disorders	74 (.1%)
Changes In Physical Activity	71 (.1%)
Abdominal Hernias And Other Abdomin...	70 (.1%)
Coagulopathies And Bleeding Diathes...	70 (.1%)
Hearing	68 (.09%)
Personality Disorders	68 (.09%)
Reproductive Tract	68 (.09%)
Ocular Hemorrhages And Vascular	61 (.08%)
Arteriosclerosis, Stenosis, Vascula...	60 (.08%)
Enzyme	59 (.08%)
Spinal Cord And Nerve Root	59 (.08%)
White Blood Cell	59 (.08%)
Administration Site Reactions	58 (.08%)

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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.