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Naproxen Side Effects

Common Naproxen Side Effects

The most commonly reported Naproxen side effects (click to view or check a box to report):

Nausea (176)
Gastrointestinal Haemorrhage (168)
Pain (144)
Renal Failure Acute (143)
Dyspnoea (135)
Completed Suicide (126)
Haemoglobin Decreased (119)
Abdominal Pain (117)
Diarrhoea (111)
Vomiting (110)
Dizziness (106)
Gastric Ulcer (101)
Haematemesis (93)
Abdominal Pain Upper (91)
Gastric Haemorrhage (84)
Chest Pain (78)
Anaemia (77)
Duodenal Ulcer (70)
Arthralgia (67)
Pruritus (66)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Naproxen Side Effects Reported to FDA

The following Naproxen reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Naproxen on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Cardiac Failure, Azotaemia
on Mar 11, 2014 Male from US , 85 years of age, weighting 215.4 lb, was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: cardiac failure, azotaemia. Naproxen dosage: N/A.

Pruritus, Rash, Swelling, Erythema
Patient was taking Naproxen. Patient felt the following Naproxen side effects: pruritus, rash, swelling, erythema on Mar 07, 2014 from US Additional patient health information: Male , 47 years of age, weighting 178.0 lb, was diagnosed with and. Naproxen dosage: N/A.

Myocardial Infarction, Pain, Headache, Hyperhidrosis, Vomiting, Chest Pain
Adverse event was reported on Mar 07, 2014 by a Female taking Naproxen Sodium (Dosage: Unk, Unk) . Location: US , 55 years of age, weighting 150.5 lb, After Naproxen was administered, patient encountered several Naproxen side effects: myocardial infarction, pain, headache, hyperhidrosis, vomiting, chest pain.
Multiple concurrent drugs taken:
  • Lithium (900 Mg, Qhs)
  • Synthroid (150 ?g, Qd)
  • Trazodone (Unk, Unk)
  • Diazepam (5 Mg, Q8h)


Malaise
on Mar 07, 2014 Male from GB , 84 years of age, weighting 187.4 lb, was treated with Naproxen 250mg 16028/0144. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: malaise. Naproxen 250mg 16028/0144 dosage: N/A.
Associated medications used:
  • Allopurinol (Unk, Unk)
  • Amoxicillin
  • Doxazosin (Unk, Unk)
  • Enoxaparin (Unk, Unk)
  • Furosemide (Unk, Unk)
  • Isosorbide Mononitrate (Unk, Unk)
  • Novomix (Unk, Unk)
  • Omeprazole



Upper Gastrointestinal Haemorrhage
on Mar 06, 2014 Male from GB , 76 years of age, was diagnosed with and was treated with Naproxen 250mg 16028/0144. Patient felt the following Naproxen side effects: upper gastrointestinal haemorrhage. Naproxen 250mg 16028/0144 dosage: Unk.
Multiple prescriptions taken:
  • Doxazosin (4 Mg, Qd)
  • Lercanidipine (10 Mg, Qd)
  • Ramipril (5 Mg, Qd)
  • Simvastatin (40 Mg, Qd)
Patient was hospitalized.

Pancreatitis, Abdominal Pain, Hyperlipasaemia
Patient was taking Naproxene Sodique Teva. After Naproxen was administered, patient encountered several Naproxen side effects: pancreatitis, abdominal pain, hyperlipasaemia on Mar 03, 2014 from FR Additional patient health information: Male , 58 years of age, was diagnosed with and. Naproxene Sodique Teva dosage: 550 Milligram Daily;.
Multiple concurrent drugs taken:
  • Codoliprane (3 Dosage Forms Daily;)
  • Cotriatec 5 Mg/ 12.5 Mg (2 Dosage Forms Daily;)
Patient was hospitalized.

Urticaria Pigmentosa, Pruritus, Flushing, Diarrhoea, Bone Pain, Palpitations, Macule, Papule
Adverse event was reported on Feb 27, 2014 by a Female taking Naproxen (Dosage: N/A) was diagnosed with and. Location: US , 39 years of age, Directly after, patient experienced the unwanted or unexpected Naproxen side effects: urticaria pigmentosa, pruritus, flushing, diarrhoea, bone pain, palpitations, macule, papule.

Corneal Perforation
on Feb 27, 2014 Female from US , 61 years of age, was diagnosed with and was treated with Naproxen. Patient felt the following Naproxen side effects: corneal perforation. Naproxen dosage: N/A.

Asthma
on Feb 26, 2014 Female from GB , 65 years of age, was diagnosed with and was treated with Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: asthma. Naproxen dosage: 500 Mg, Bid. Patient was hospitalized.

Rash, Blister, Stomatitis, Mouth Haemorrhage
Patient was taking Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: rash, blister, stomatitis, mouth haemorrhage on Feb 21, 2014 from US Additional patient health information: Female , 68 years of age, weighting 140.0 lb, was diagnosed with and. Naproxen dosage: 2 Pills Daily With Meals.
Associated medications used:
  • Premarin
  • Spironolact
  • Calcium W/ Vitamin D
  • Glucosamine W/ Chondroitin
  • Zolpidem


Skin Exfoliation, Dry Skin, Pain Of Skin, Discomfort
Adverse event was reported on Feb 24, 2014 by a Female taking Naproxen (Dosage: 1000 Mg, Unk) was diagnosed with and. Location: GB , 40 years of age, weighting 132.3 lb, Patient felt the following Naproxen side effects: skin exfoliation, dry skin, pain of skin, discomfort.
Multiple prescriptions taken:
  • Omeprazole (20 Mg, Unk)
  • Zapain
  • Codeine
  • Ibuprofen
  • Tramadol
  • Gabapentin
  • Levothyroxine
  • Magnesium


Photosensitivity Reaction
on Feb 14, 2014 Male from US , 52 years of age, was treated with Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: photosensitivity reaction. Naproxen dosage: N/A.
Multiple concurrent drugs taken:
  • Cymbalta
  • Abilify
  • Seroquel
  • Lamictal


Gastrointestinal Haemorrhage, Haemoglobin Decreased
on Feb 12, 2014 Male from US , 66 years of age, was diagnosed with and was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: gastrointestinal haemorrhage, haemoglobin decreased. Naproxen dosage: N/A. Patient was hospitalized.

Skin Exfoliation, Dry Skin, Pain Of Skin, Discomfort
Patient was taking Naproxen. Patient felt the following Naproxen side effects: skin exfoliation, dry skin, pain of skin, discomfort on Feb 26, 2014 from GB Additional patient health information: Female , 40 years of age, weighting 132.3 lb, was diagnosed with and. Naproxen dosage: Unk.
Multiple prescriptions taken:
  • Omeprazole (Unk)
  • Zapain (Unk)
  • Codeine (Unk)
  • Ibuprofen (Unk)
  • Tramadol (Unk)
  • Gabapentin (Unk)
  • Levothyroxine (Unk)
  • Magnesium (Unk)


Dyspnoea
Adverse event was reported on Feb 14, 2014 by a Male taking Naproxen (Dosage: N/A) . Location: GB , 62 years of age, weighting 166.0 lb, After Naproxen was administered, patient encountered several Naproxen side effects: dyspnoea.
Multiple concurrent drugs taken:
  • Calcipotriol (Unk)
  • Dovobet (Unk)
  • Beconase (Unk)


Haemorrhage, Hypopnoea
on Feb 13, 2014 Female from US , weighting 179.0 lb, was diagnosed with and was treated with Naproxen Sodium 220 Mg 368. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: haemorrhage, hypopnoea. Naproxen Sodium 220 Mg 368 dosage: 440 Mg, Qd.
Associated medications used:
  • Analgesics (Unk, Unk)
  • Prozac (Unk, Unk)
  • Nortriptyline (Unk, Unk)
  • Omeprazole (Unk, Unk)
  • Topamax (Unk, Unk)
  • Acetaminophen (1000 Mg, Bid)
  • Acetaminophen (500 Mg, Qhs)
  • Sucralfate (Unk, Unk)
Patient was hospitalized.

Asthma
on Feb 12, 2014 Female from GB , 65 years of age, was diagnosed with and was treated with Naproxen 250mg 16028/0144. Patient felt the following Naproxen side effects: asthma. Naproxen 250mg 16028/0144 dosage: 500 Mg, Bid. Patient was hospitalized.

Discomfort, Dry Skin, Pain Of Skin, Skin Exfoliation
Patient was taking Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: discomfort, dry skin, pain of skin, skin exfoliation on Feb 10, 2014 from GB Additional patient health information: Female , 40 years of age, weighting 132.3 lb, was diagnosed with and. Naproxen dosage: N/A.
Multiple concurrent drugs taken:
  • Omeprazole
  • Zapain
  • Tramadol
  • Codeine
  • Gabapentin
  • Ibuprofen
  • Levothyroxine
  • Magnesium


Rectal Haemorrhage, Renal Failure Acute
Adverse event was reported on Feb 07, 2014 by a Male taking Naproxen (Dosage: N/A) was diagnosed with and. Location: US , weighting 172.2 lb, Directly after, patient experienced the unwanted or unexpected Naproxen side effects: rectal haemorrhage, renal failure acute. Patient was hospitalized.

Discomfort, Dry Skin, Pain Of Skin, Skin Exfoliation
on Feb 11, 2014 Female from GB , 40 years of age, weighting 132.3 lb, was diagnosed with and was treated with Naproxen. Patient felt the following Naproxen side effects: discomfort, dry skin, pain of skin, skin exfoliation. Naproxen dosage: N/A.
Multiple prescriptions taken:
  • Omeprazole
  • Codeine
  • Gabapentin
  • Ibuprofen
  • Levothyroxine
  • Selenium
  • Tramadol
  • Zapain


Chest Discomfort
on Feb 06, 2014 Male from GB , 31 years of age, weighting 176.4 lb, was treated with Naproxen (naproxen). After Naproxen was administered, patient encountered several Naproxen side effects: chest discomfort. Naproxen (naproxen) dosage: N/A.

Thalamic Infarction, Loss Of Consciousness, Blood Creatinine Increased, Blood Magnesium Decreased, Haematocrit Decreased, Haemoglobin Decreased, Red Blood Cell Count Decreased, Local Swelling
Patient was taking Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: thalamic infarction, loss of consciousness, blood creatinine increased, blood magnesium decreased, haematocrit decreased, haemoglobin decreased, red blood cell count decreased, local swelling on Feb 05, 2014 from US Additional patient health information: Female , 53 years of age, weighting 347.0 lb, was diagnosed with and. Naproxen dosage: N/A. Patient was hospitalized.

Dyspnoea
Adverse event was reported on Feb 07, 2014 by a Male taking Naproxen 250mg 16028/0144 (Dosage: Unk, Unk) . Location: GB , 62 years of age, weighting 166.0 lb, Patient felt the following Naproxen side effects: dyspnoea.
Multiple prescriptions taken:
  • Beconase (Unk, Unk)
  • Calcipotriol (Unk, Unk)
  • Dovobet (Unk, Unk)


Chest Discomfort
on Feb 07, 2014 Male from GB , 31 years of age, weighting 176.4 lb, was treated with Naproxen. After Naproxen was administered, patient encountered several Naproxen side effects: chest discomfort. Naproxen dosage: Unk.

Anaphylactic Reaction
on Feb 06, 2014 Female from COUNTRY NOT SPECIFIED , 36 years of age, was diagnosed with and was treated with Naproxen. Directly after, patient experienced the unwanted or unexpected Naproxen side effects: anaphylactic reaction. Naproxen dosage: N/A.
Associated medications used:
  • Purified Protein Derivative
  • Neurotropin
  • Antidepressant
  • Thyroid Hormone Preparation
  • Vitamin Preparation
  • Contraceptives


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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • 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.

    Discuss Naproxen Side Effects

    Did You Have a Naproxen Side Effect?

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    How Effective is Naproxen for You?

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    Safety Alerts, Active Ingredients, Usage 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: 3184

    Naproxen safety alerts: 2013 2004

    Reported deaths: 359

    Reported hospitalizations: 1198

    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]

    Latest Naproxen clinical trials