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Naproxen Side Effects

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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.

Naproxen Side Effects Reported to FDA



Naproxen Side Effect Report#9999469
Cardiac Failure, Azotaemia
This is a report of a 85-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Naproxen (dosage: NA, start time:
Aug 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Cardiac Failure, Azotaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen treatment in male patients, resulting in Cardiac Failure side effect.
Naproxen Side Effect Report#9995487
Pruritus, Rash, Swelling, Erythema
This report suggests a potential Naproxen Pruritus side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Naproxen (dosage: NA) starting
Jan 28, 2014. After starting Naproxen the patient began experiencing various side effects, including: Pruritus, Rash, Swelling, ErythemaAdditional drugs used concurrently: NA. Although Naproxen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pruritus, may still occur.
Naproxen Side Effect Report#9981297
Myocardial Infarction, Pain, Headache, Hyperhidrosis, Vomiting, Chest Pain
This Myocardial Infarction problem was reported by a physician from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 1983 this consumer started treatment with Naproxen Sodium (dosage: Unk, Unk). The following drugs were being taken at the same time:
  • Lithium (900 Mg, Qhs)
  • Synthroid (150 ?g, Qd)
  • Trazodone (Unk, Unk)
  • Diazepam (5 Mg, Q8h)
When using Naproxen Sodium, the patient experienced the following unwanted symptoms/side effects: Myocardial Infarction, Pain, Headache, Hyperhidrosis, Vomiting, Chest PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Naproxen Side Effect Report#9981292
Malaise
This Malaise side effect was reported by a physician from GB. A 84-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Naproxen 250mg 16028/0144 (drug dosage: NA), which was initiated on
Dec 05, 2013. Concurrently used drugs:
  • Allopurinol (Unk, Unk)
  • Amoxicillin
  • Doxazosin (Unk, Unk)
  • Enoxaparin (Unk, Unk)
  • Furosemide (Unk, Unk)
  • Isosorbide Mononitrate (Unk, Unk)
  • Novomix (Unk, Unk)
  • Omeprazole
.After starting to take Naproxen 250mg 16028/0144 the consumer reported adverse symptoms, such as: MalaiseThese side effects may potentially be related to Naproxen 250mg 16028/0144.
Naproxen Side Effect Report#9972949
Upper Gastrointestinal Haemorrhage
This is a report of a 76-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: gout,hypertension, who was treated with Naproxen 250mg 16028/0144 (dosage: Unk, start time:
Feb 07, 2014), combined with:
  • Doxazosin (4 Mg, Qd)
  • Lercanidipine (10 Mg, Qd)
  • Ramipril (5 Mg, Qd)
  • Simvastatin (40 Mg, Qd)
and developed a serious reaction and side effect(s): Upper Gastrointestinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen 250mg 16028/0144 treatment in male patients, resulting in Upper Gastrointestinal Haemorrhage side effect. The patient was hospitalized.
Naproxen Side Effect Report#9942389
Pancreatitis, Abdominal Pain, Hyperlipasaemia
This report suggests a potential Naproxene Sodique Teva Pancreatitis side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: neck pain and used Naproxene Sodique Teva (dosage: 550 Milligram Daily;) starting
Jan 10, 2014. After starting Naproxene Sodique Teva the patient began experiencing various side effects, including: Pancreatitis, Abdominal Pain, HyperlipasaemiaAdditional drugs used concurrently:
  • Codoliprane (3 Dosage Forms Daily;)
  • Cotriatec 5 Mg/ 12.5 Mg (2 Dosage Forms Daily;)
The patient was hospitalized. Although Naproxene Sodique Teva demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis, may still occur.
Naproxen Side Effect Report#9928329
Urticaria Pigmentosa, Pruritus, Flushing, Urticaria, Diarrhoea, Bone Pain, Palpitations, Macule, Papule
This Urticaria Pigmentosa problem was reported by a health professional from US. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: headache. On NS this consumer started treatment with Naproxen (dosage: NA). The following drugs were being taken at the same time: NA. When using Naproxen, the patient experienced the following unwanted symptoms/side effects: Urticaria Pigmentosa, Pruritus, Flushing, Urticaria, Diarrhoea, Bone Pain, Palpitations, Macule, PapuleAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Urticaria Pigmentosa, may become evident only after a product is in use by the general population.
Naproxen Side Effect Report#9927739
Corneal Perforation
This Corneal Perforation side effect was reported by a physician from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Naproxen (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Naproxen the consumer reported adverse symptoms, such as: Corneal PerforationThese side effects may potentially be related to Naproxen.
Naproxen Side Effect Report#9924283
Asthma
This is a report of a 65-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: pain, who was treated with Naproxen (dosage: 500 Mg, Bid, start time:
Jan 27, 2014), combined with: NA. and developed a serious reaction and side effect(s): Asthma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen treatment in female patients, resulting in Asthma side effect. The patient was hospitalized.
Naproxen Side Effect Report#9921785
Rash, Blister, Stomatitis, Mouth Haemorrhage
This report suggests a potential Naproxen Rash side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthropathy and used Naproxen (dosage: 2 Pills Daily With Meals) starting
Nov 13, 2013. After starting Naproxen the patient began experiencing various side effects, including: Rash, Blister, Stomatitis, Mouth HaemorrhageAdditional drugs used concurrently:
  • Premarin
  • Spironolact
  • Calcium W/ Vitamin D
  • Glucosamine W/ Chondroitin
  • Zolpidem
Although Naproxen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Naproxen Side Effect Report#9920199
Skin Exfoliation, Dry Skin, Pain Of Skin, Discomfort
This Skin Exfoliation problem was reported by a health professional from GB. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On
Dec 01, 2013 this consumer started treatment with Naproxen (dosage: 1000 Mg, Unk). The following drugs were being taken at the same time:
  • Omeprazole (20 Mg, Unk)
  • Zapain
  • Codeine
  • Ibuprofen
  • Tramadol
  • Gabapentin
  • Levothyroxine
  • Magnesium
When using Naproxen, the patient experienced the following unwanted symptoms/side effects: Skin Exfoliation, Dry Skin, Pain Of Skin, DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Skin Exfoliation, may become evident only after a product is in use by the general population.
Naproxen Side Effect Report#9909279
Photosensitivity Reaction
This Photosensitivity Reaction side effect was reported by a pharmacist from US. A 52-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Naproxen (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cymbalta
  • Abilify
  • Seroquel
  • Lamictal
.After starting to take Naproxen the consumer reported adverse symptoms, such as: Photosensitivity ReactionThese side effects may potentially be related to Naproxen.
Naproxen Side Effect Report#9908573
Gastrointestinal Haemorrhage, Haemoglobin Decreased
This is a report of a 66-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Naproxen (dosage: NA, start time:
May 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Gastrointestinal Haemorrhage, Haemoglobin Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen treatment in male patients, resulting in Gastrointestinal Haemorrhage side effect. The patient was hospitalized.
Naproxen Side Effect Report#9904194
Skin Exfoliation, Dry Skin, Pain Of Skin, Discomfort
This report suggests a potential Naproxen Skin Exfoliation side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: back pain and used Naproxen (dosage: Unk) starting
Dec 01, 2013. After starting Naproxen the patient began experiencing various side effects, including: Skin Exfoliation, Dry Skin, Pain Of Skin, DiscomfortAdditional drugs used concurrently:
  • Omeprazole (Unk)
  • Zapain (Unk)
  • Codeine (Unk)
  • Ibuprofen (Unk)
  • Tramadol (Unk)
  • Gabapentin (Unk)
  • Levothyroxine (Unk)
  • Magnesium (Unk)
Although Naproxen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Skin Exfoliation, may still occur.
Naproxen Side Effect Report#9897266
Dyspnoea
This Dyspnoea problem was reported by a health professional from GB. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 20, 2013 this consumer started treatment with Naproxen (dosage: NA). The following drugs were being taken at the same time:
  • Calcipotriol (Unk)
  • Dovobet (Unk)
  • Beconase (Unk)
When using Naproxen, the patient experienced the following unwanted symptoms/side effects: DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Naproxen Side Effect Report#9893417
Haemorrhage, Hypopnoea
This Haemorrhage side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Naproxen Sodium 220 Mg 368 (drug dosage: 440 Mg, Qd), which was initiated on 201308. Concurrently used drugs:
  • 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)
.After starting to take Naproxen Sodium 220 Mg 368 the consumer reported adverse symptoms, such as: Haemorrhage, HypopnoeaThese side effects may potentially be related to Naproxen Sodium 220 Mg 368. The patient was hospitalized.
Naproxen Side Effect Report#9891915
Asthma
This is a report of a 65-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: pain, who was treated with Naproxen 250mg 16028/0144 (dosage: 500 Mg, Bid, start time:
Jan 27, 2014), combined with: NA. and developed a serious reaction and side effect(s): Asthma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen 250mg 16028/0144 treatment in female patients, resulting in Asthma side effect. The patient was hospitalized.
Naproxen Side Effect Report#9891264
Discomfort, Dry Skin, Pain Of Skin, Skin Exfoliation, Skin Exfoliation
This report suggests a potential Naproxen Discomfort side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: back pain and used Naproxen (dosage: NA) starting
Dec 01, 2013. After starting Naproxen the patient began experiencing various side effects, including: Discomfort, Dry Skin, Pain Of Skin, Skin Exfoliation, Skin ExfoliationAdditional drugs used concurrently:
  • Omeprazole
  • Zapain
  • Tramadol
  • Codeine
  • Gabapentin
  • Ibuprofen
  • Levothyroxine
  • Magnesium
Although Naproxen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Discomfort, may still occur.
Naproxen Side Effect Report#9887741
Rectal Haemorrhage, Renal Failure Acute
This Rectal Haemorrhage problem was reported by a pharmacist from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis. On
Sep 15, 2012 this consumer started treatment with Naproxen (dosage: NA). The following drugs were being taken at the same time: NA. When using Naproxen, the patient experienced the following unwanted symptoms/side effects: Rectal Haemorrhage, Renal Failure AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rectal Haemorrhage, may become evident only after a product is in use by the general population.
Naproxen Side Effect Report#9887453
Discomfort, Dry Skin, Pain Of Skin, Skin Exfoliation
This Discomfort side effect was reported by a consumer or non-health professional from GB. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Naproxen (drug dosage: NA), which was initiated on
Dec 01, 2013. Concurrently used drugs:
  • Omeprazole
  • Codeine
  • Gabapentin
  • Ibuprofen
  • Levothyroxine
  • Selenium
  • Tramadol
  • Zapain
.After starting to take Naproxen the consumer reported adverse symptoms, such as: Discomfort, Dry Skin, Pain Of Skin, Skin ExfoliationThese side effects may potentially be related to Naproxen.
Naproxen Side Effect Report#9885847
Chest Discomfort
This is a report of a 31-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Naproxen (naproxen) (dosage: NA, start time:
Jan 16, 2014), combined with: NA. and developed a serious reaction and side effect(s): Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen (naproxen) treatment in male patients, resulting in Chest Discomfort side effect.
Naproxen Side Effect Report#9881902
Thalamic Infarction, Loss Of Consciousness, Blood Creatinine Increased, Blood Magnesium Decreased, Haematocrit Decreased, Haemoglobin Decreased, Red Blood Cell Count Decreased, Local Swelling
This report suggests a potential Naproxen Thalamic Infarction side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoarthritis and used Naproxen (dosage: NA) starting
Sep 30, 2008. After starting Naproxen the patient began experiencing various side effects, including: Thalamic Infarction, Loss Of Consciousness, Blood Creatinine Increased, Blood Magnesium Decreased, Haematocrit Decreased, Haemoglobin Decreased, Red Blood Cell Count Decreased, Local SwellingAdditional drugs used concurrently: NA.The patient was hospitalized. Although Naproxen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thalamic Infarction, may still occur.
Naproxen Side Effect Report#9881335
Dyspnoea
This Dyspnoea problem was reported by a physician from GB. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 25, 2013 this consumer started treatment with Naproxen 250mg 16028/0144 (dosage: Unk, Unk). The following drugs were being taken at the same time:
  • Beconase (Unk, Unk)
  • Calcipotriol (Unk, Unk)
  • Dovobet (Unk, Unk)
When using Naproxen 250mg 16028/0144, the patient experienced the following unwanted symptoms/side effects: DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Naproxen Side Effect Report#9880471
Chest Discomfort
This Chest Discomfort side effect was reported by a health professional from GB. A 31-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Naproxen (drug dosage: Unk), which was initiated on
Jan 16, 2014. Concurrently used drugs: NA..After starting to take Naproxen the consumer reported adverse symptoms, such as: Chest DiscomfortThese side effects may potentially be related to Naproxen.
Naproxen Side Effect Report#9879605
Anaphylactic Reaction
This is a report of a 36-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: fibromyalgia,tuberculin test, who was treated with Naproxen (dosage: NA, start time: NS), combined with:
  • Purified Protein Derivative
  • Neurotropin
  • Antidepressant
  • Thyroid Hormone Preparation
  • Vitamin Preparation
  • Contraceptives
and developed a serious reaction and side effect(s): Anaphylactic Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Naproxen treatment in female patients, resulting in Anaphylactic Reaction side effect.


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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.

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What are common Naproxen Side Effects for Women?

Women Side EffectsReports
Pain 116
Nausea 106
Abdominal Pain 65
Vomiting 65
Completed Suicide 64
Pulmonary Embolism 60
Dyspnoea 59
Deep Vein Thrombosis 56
Gastrointestinal Haemorrhage 56
Abdominal Pain Upper 55

What are common Naproxen Side Effects for Men?

Men Side EffectsReports
Gastrointestinal Haemorrhage 109
Renal Failure Acute 86
Dyspnoea 74
Gastric Haemorrhage 71
Dizziness 68
Haemoglobin Decreased 65
Nausea 65
Gastric Ulcer 56
Diarrhoea 55
Abdominal Pain 50

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

    Discuss Naproxen Side Effects

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    Naproxen Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0147
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameNaproxen
    NameNaproxen
    Dosage FormTABLET
    RouteORAL
    On market since19931222
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)NAPROXEN
    Strength(s)250
    Unit(s)mg/1
    Pharma ClassCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonst

    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