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Bloated Stomach (16)
Nausea (10)
Hyper Foggy Head (9)
Lost Sense Of Taste; Abdominal Pain (8)
Abdominal Pain Like Trapped Gas (6)
Stomach Pain (5)
Bruising (4)
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Naproxen Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 2412 

Pulmonary Embolism, Thrombophlebitis (8465064-7)
on Jun 18, 2012 Female from UNITED STATES , 43 years of age, weighting 218.3 lb, was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: pulmonary embolism, thrombophlebitis. Naproxen dosage: 550 Mg, Unk.
Associated medications used:
  • Omeprazole (20 Mg Daily)
  • Cyclobenzaprine (10 Mg, Unk)
  • Propoxyphene/ Naproxen/ Acetaminophen. (100/650 Mg)
  • Thyroid Tab (60 Mg Daily)
  • Ziac
  • Yasmin
  • Bisoprolol Fumarate And Hydrochlorothiazide (10 Mg/6.25 Daily)
  • Furosemide (40 Mg, Unk)
Patient was hospitalized.

Respiratory Arrest, Incorrect Dose Administered, Pulse Absent, Unresponsive To Stimuli, Snoring (8465010-6)
Patient was taking Naproxen. Patient felt the following Naproxen side effects: respiratory arrest, incorrect dose administered, pulse absent, unresponsive to stimuli, snoring on May 07, 2012 from UNITED STATES Additional patient health information: Male , 23 years of age, weighting 143.3 lb, . Naproxen dosage: N/A.
Multiple prescriptions taken:
  • Hydromorphone Hcl (2 Mg;qh;prn;iv)


Vision Blurred (8464496-0)
Adverse event was reported on Jun 12, 2012 by a Male taking Naproxen (Dosage: Unk) . Location: ISRAEL , 46 years of age, weighting 187.4 lb, After Naproxen was administered, patient encountered several Naproxen side effects: vision blurred.

No Adverse Event (8463812-3)
on Jun 21, 2012 Female from UNITED STATES , 28 years of age, was diagnosed with
  • toothache
and was treated with Naproxen (aleve). Directly after, patient experienced the unwanted or unexpected Naproxen side effects: no adverse event. Naproxen (aleve) dosage: 4 Df, Once.


Pulmonary Embolism (8462398-7)
on Jun 18, 2012 Female from UNITED STATES , 31 years of age, weighting 126.0 lb, was treated with Naproxen Sodium. Patient felt the following Naproxen side effects: pulmonary embolism. Naproxen Sodium dosage: 550 Mg Tablets; Twice Daily. Patient was hospitalized.

Coeliac Disease, Weight Decreased (8462158-7)
Patient was taking Naproxen (aleve). After Naproxen was administered, patient encountered several Naproxen side effects: coeliac disease, weight decreased on Jun 15, 2012 from UNITED STATES Additional patient health information: Female , 60 years of age, . Naproxen (aleve) dosage: N/A.
Multiple concurrent drugs taken:
  • Anti Depressants
  • Tylenol-500


Vision Blurred (8461819-3)
Adverse event was reported on Jun 11, 2012 by a Male taking Naproxen (Dosage: N/A) . Location: DENMARK , 46 years of age, Directly after, patient experienced the unwanted or unexpected Naproxen side effects: vision blurred.

Migraine, Nausea, Oesophageal Rupture, Vomiting, Gastritis, Pneumomediastinum (8461257-3)
on Jun 19, 2012 Male from UNITED STATES , 30 years of age, was diagnosed with
  • migraine
and was treated with Naproxen. Patient felt the following Naproxen side effects: migraine, nausea, oesophageal rupture, vomiting, gastritis, pneumomediastinum. Naproxen dosage: Po. Patient was hospitalized.

Dyspnoea, Dehydration, Chronic Respiratory Failure (8458669-0)
on Jun 19, 2012 Male from UNITED STATES , 82 years of age, weighting 129.0 lb, was diagnosed with
  • musculoskeletal chest pain
  • weight decreased
  • insomnia
  • hyperlipidaemia
and was treated with Naproxen Sodium. After Naproxen was administered, patient encountered several Naproxen side effects: dyspnoea, dehydration, chronic respiratory failure. Naproxen Sodium dosage: 440 Mcg Prn.
Multiple concurrent drugs taken:
  • Megace (4 Df, Qd)
  • Ambien (Unk)
  • Aspirin (Daily Dose 81 Mg)
  • Vitamin D (Daily Dose 7000 U)
  • Vitamin D (Daily Dose 1000 U)
  • Robitussin Ex (One Tsp, Prn)
  • Azithromycin (Daily Dose 500 Mg)
  • Synthroid (Daily Dose 175 Mcg)
Patient was hospitalized.

No Adverse Event (8458574-X)
Patient was taking Naproxen (aleve). Directly after, patient experienced the unwanted or unexpected Naproxen side effects: no adverse event on May 25, 2012 from UNITED STATES Additional patient health information: Female , 27 years of age, weighting 209.4 lb, was diagnosed with
  • headache
and. Naproxen (aleve) dosage: 2 Df, Bid.

Duodenal Ulcer, Haemoglobin Decreased, Melaena, Haematemesis (8458121-2)
Adverse event was reported on Jun 11, 2012 by a Female taking Naproxen (Dosage: 500 Mg, Bid) . Location: UNITED KINGDOM , 72 years of age, Patient felt the following Naproxen side effects: duodenal ulcer, haemoglobin decreased, melaena, haematemesis.
Multiple prescriptions taken:
  • Senna-mint Waf (As Necessary)
  • Lactulose (10 Ml, Bid)
  • Quinine Sulfate (300 Mg, Qd)
  • Ramipril (5 Mg, Qd)
  • Albuterol (2 Df, Bid)
  • Bendroflumethiazide (2.5 Mg, Qd)
  • Fostair (2 Df, Bid)
  • Omeprazole (40 Mg, Qd)
Patient was hospitalized.

Haematemesis, Gastrointestinal Haemorrhage, Haemoglobin Decreased (8458119-4)
on Jun 12, 2012 Male from UNITED KINGDOM , 69 years of age, was diagnosed with
  • gout
and was treated with Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: haematemesis, gastrointestinal haemorrhage, haemoglobin decreased. Naproxen dosage: 500 Mg, Unk. Patient was hospitalized.

Vision Blurred (8458116-9)
on Jun 11, 2012 Male from UNITED KINGDOM , 46 years of age, weighting 187.4 lb, was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: vision blurred. Naproxen dosage: Unk.

Vision Blurred (8455724-6)
Patient was taking Naproxen Sodium. Patient felt the following Naproxen side effects: vision blurred on Jun 11, 2012 from SWITZERLAND Additional patient health information: Male , 46 years of age, weighting 187.4 lb, . Naproxen Sodium dosage: N/A.

Dyspnoea, Condition Aggravated, Diabetes Mellitus, Hypertension, Gait Disturbance, Insomnia, Back Pain, Blood Creatine Increased, Arthralgia (8454726-3)
Adverse event was reported on May 30, 2012 by a Female taking Naproxen Sodium (Dosage: Oral) was diagnosed with
  • arthritis
  • hypertension
  • diabetes mellitus
and. Location: UNITED STATES , 51 years of age, weighting 228.0 lb, After Naproxen was administered, patient encountered several Naproxen side effects: dyspnoea, condition aggravated, diabetes mellitus, hypertension, gait disturbance, insomnia, back pain, blood creatine increased, arthralgia.
Multiple concurrent drugs taken:
  • Aliskiren And Valsartan (Oral)
  • Metformin Hcl
  • Sitalgliptin
  • Xyrem
  • Xyrem
  • Xyrem
  • Xyrem
  • Sotalol Hydrochloride


Hypertonic Bladder, Blood Sodium Decreased, Gallbladder Polyp, Nerve Compression, Renal Atrophy, Nausea, Vitamin B12 Decreased, Vertigo, Rheumatoid Arthritis (8454192-8)
on Jun 15, 2012 Female from CANADA , weighting 140.1 lb, was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: hypertonic bladder, blood sodium decreased, gallbladder polyp, nerve compression, renal atrophy, nausea, vitamin b12 decreased, vertigo, rheumatoid arthritis. Naproxen dosage: N/A.
Associated medications used:
  • Oxycet
  • Methotrexate (1cc)
  • Zoplicone (unk Ingredients)
  • Mabthera (Day 1, Day 15)
  • Pantoprazole Sodium
  • Zofran
  • Serc
  • Extra Strength Tylenol
Patient was hospitalized.

Hyperhidrosis, Pruritus, Abscess (8450994-2)
on Jun 11, 2012 Male from GERMANY , 43 years of age, was treated with Naproxen. Patient felt the following Naproxen side effects: hyperhidrosis, pruritus, abscess. Naproxen dosage: 500 Mg, 1x/day.
Multiple prescriptions taken:
  • Cortisone Acetate (2 Mg, 1x/day)
  • Omeprazole (Unk)
  • Enbrel (50 Mg, Weekly)


Dyspepsia, Scar, Flatulence, Anxiety, Pain, Biliary Colic, Constipation, Depression, Emotional Disorder (8450196-X)
Patient was taking Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: dyspepsia, scar, flatulence, anxiety, pain, biliary colic, constipation, depression, emotional disorder on Jun 12, 2012 from UNITED STATES Additional patient health information: Female , 21 years of age, weighting 119.0 lb, . Naproxen dosage: Unk.
Multiple concurrent drugs taken:
  • Drospirenone And Ethinyl Estradiol (Unk)
  • Yasmin (Unk)
Patient was hospitalized.

Hepatic Enzyme Increased, Thyroid Function Test Abnormal, Thyroid Neoplasm, Dysphagia, Lymphadenopathy, Choking Sensation, Dyspnoea Exertional, Exfoliative Rash, Weight Increased (8448016-2)
Adverse event was reported on Jun 13, 2012 by a Female taking Naproxen (aleve) (Dosage: N/A) . Location: UNITED STATES , 45 years of age, Directly after, patient experienced the unwanted or unexpected Naproxen side effects: hepatic enzyme increased, thyroid function test abnormal, thyroid neoplasm, dysphagia, lymphadenopathy, choking sensation, dyspnoea exertional, exfoliative rash, weight increased.
Associated medications used:
  • Betaseron (8 Miu, Qod)
  • Cyclobenzaprine (15 Mg, Hs)
  • Triamterene And Hydrochlorothiazide (37.5/25)
  • Betaseron (8 Miu, Qod)
  • Baclofen (10 Mg, Bid)


Malaise, Dry Mouth, Nausea, Oedema Peripheral, Somnolence, Asthenia, Feeling Abnormal (8447624-2)
on Jun 14, 2012 Female from UNITED STATES , weighting 175.0 lb, was diagnosed with
  • nasopharyngitis
and was treated with Naproxen Sodium And Pseudoephedrine Hydrochloride. Patient felt the following Naproxen side effects: malaise, dry mouth, nausea, oedema peripheral, somnolence, asthenia, feeling abnormal. Naproxen Sodium And Pseudoephedrine Hydrochloride dosage: One Tablet, Single.

Toxicity To Various Agents, Overdose (8447603-5)
on Jun 06, 2012 Female from UNITED STATES , 36 years of age, weighting 280.0 lb, was treated with Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: toxicity to various agents, overdose. Naproxen dosage: N/A.
Multiple concurrent drugs taken:
  • Minocycline Hcl
  • Desyrel
  • Prevacid
  • Ativan
  • Zofran
  • Fentanyl-100
  • Oxycodone And Acetaminophen
  • Restoril


Gastric Haemorrhage (8447542-X)
Patient was taking Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: gastric haemorrhage on Jun 13, 2012 from UNITED STATES Additional patient health information: Female , 53 years of age, weighting 190.3 lb, . Naproxen dosage: N/A. Patient was hospitalized.

Cushing's Syndrome, Lipohypertrophy, Muscle Atrophy, Hypoaldosteronism, Hypotension, Salt Craving, Malaise, Cushingoid, Adrenal Insufficiency (8447052-X)
Adverse event was reported on Jun 13, 2012 by a Female taking Naproxen (Dosage: 500 Mg, Tid) was diagnosed with
  • bone pain
  • asthma
and. Location: NETHERLANDS , 70 years of age, Patient felt the following Naproxen side effects: cushing's syndrome, lipohypertrophy, muscle atrophy, hypoaldosteronism, hypotension, salt craving, malaise, cushingoid, adrenal insufficiency.
Multiple prescriptions taken:
  • Prednisone (15 Mg, Unk)


Vision Blurred (8446980-9)
on Jun 11, 2012 Male from UNITED KINGDOM , 46 years of age, weighting 187.4 lb, was treated with Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: vision blurred. Naproxen dosage: Unk.

Abdominal Pain Upper, Vomiting, Unevaluable Event (8446845-2)
on Jun 12, 2012 Female from UNITED STATES , 67 years of age, was diagnosed with
  • arthritis
and was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: abdominal pain upper, vomiting, unevaluable event. Naproxen dosage: 500 Mg, 2 Times A Day, Po.

Showing 1-25 of 2412 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Naproxen Information

Alternative NAPROXEN Names:ALEVE ALL DAY PAIN RELIEF ALL DAY RELIEF ANAPROX ANAPROX DS BEING WELL ALL DAY BERKLEY AND JENSEN CARE ONE ALL DAY PA DG HEALTH ALL DAY P EC-NAPROSYN EQUALINE ALL DAY PA EXCHANGE SELECT NAP GOOD NEIGHBOR PHARM GOOD SENSE ALL DAY HEALTH MART NAPROXE HEALTHY ACCENTS ALL HEALTHY ACCENTS NAP KIRKLAND SIGNATURE LEADER ALL DAY PAIN MEDIQUE MEDIPROXEN MEMBERS MARK NAPROX MIDOL EXTENDED RELI NAPRELAN NAPROSYN PAIN RELIEF REXALL ALL DAY PAIN RX ACT ALL DAY PAIN SIMPLY RIGHT NAPROX SMART SENSE NAPROXE SUDAFED SUNMARK ALL DAY REL THERAPROXEN THERAPROXEN-500 THERAPROXEN-90 TOPCARE ALL DAY PAI TREPOXEN-250 VIMOVO

Active Ingredient: ESOMEPRAZ NAPROXEN

Naproxen Dosage, Warnings, Usage.

Side Effects reported to FDA: 2412. View Naproxen Adverse Reports

Naproxen safety alerts: 2004

Reported deaths: 252

Reported hospitalizations: 937

Naproxen

Audience: Rheumatologists and other healthcare professionals 

FDA announced that it was reviewing the available scientific information on naproxen following the decision of the National Institute on Aging to halt a clinical trial studying non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's disease. Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen. FDA advises patients who are currently taking over-the-counter naproxen products to carefully follow the instructions on the label. Patients should not exceed the recommended doses for naproxen (220 milligrams twice daily) and should not take naproxen for longer than ten days unless a physician directs otherwise.

[December 20, 2004 - Statement - FDA]

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