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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
This is a report of a 85-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Cardiac Failure
  • Azotaemia
which developed 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.

Pruritus, Rash, Swelling, Erythema
This report suggests a potential Naproxen Pruritus, Rash, Swelling, Erythema 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. Soon after starting Naproxen the patient began experiencing various side effects, including:
  • Pruritus
  • Rash
  • Swelling
  • Erythema
Drugs used concurrently: NA. Although Naproxen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pruritus, may still occur.

Myocardial Infarction, Pain, Headache, Hyperhidrosis, Vomiting, Chest Pain
This Myocardial Infarction, Pain, Headache, Hyperhidrosis, Vomiting, Chest Pain 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 commencing Naproxen Sodium, the patient experienced the following unwanted symptoms/side effects:
  • Myocardial Infarction
  • Pain
  • Headache
  • Hyperhidrosis
  • Vomiting
  • Chest Pain
Although 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.

Malaise
This is a report of a 84-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Naproxen 250mg 16028/0144 (dosage: NA) starting 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
Soon after that, the consumer experienced the following side effects:
  • Malaise
This opens a possibility that Naproxen 250mg 16028/0144 treatment could cause the above reactions, including malaise, and some male subjects may be more susceptible.


Upper Gastrointestinal Haemorrhage
A 76-year-old male patient (weight: NA) from GB with the following symptoms/conditions: gout,hypertension started Naproxen 250mg 16028/0144 treatment (dosage: Unk) on Feb 07, 2014. Soon after starting Naproxen 250mg 16028/0144 treatment, the subject experienced various side effects, including:
  • Upper Gastrointestinal Haemorrhage
Concurrently used drugs:
  • Doxazosin (4 Mg, Qd)
  • Lercanidipine (10 Mg, Qd)
  • Ramipril (5 Mg, Qd)
  • Simvastatin (40 Mg, Qd)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Naproxen 250mg 16028/0144.

Pancreatitis, Abdominal Pain, Hyperlipasaemia
A 58-year-old male patient from FR (weight: NA) experienced symptoms, such as: neck pain and was treated with Naproxene Sodique Teva(dosage: 550 Milligram Daily;). The treatment was initiated on Jan 10, 2014. After that a consumer reported the following side effect(s):
  • Pancreatitis
  • Abdominal Pain
  • Hyperlipasaemia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Naproxene Sodique Teva efficacy:
  • Codoliprane (3 Dosage Forms Daily;)
  • Cotriatec 5 Mg/ 12.5 Mg (2 Dosage Forms Daily;)
The patient was hospitalized.

Urticaria Pigmentosa, Pruritus, Flushing, Diarrhoea, Bone Pain, Palpitations, Macule, Papule
In this report, Naproxen was administered for the following condition: headache.A 39-year-old female consumer from US (weight: NA) started Naproxen treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Urticaria Pigmentosa
  • Pruritus
  • Flushing
  • Diarrhoea
  • Bone Pain
  • Palpitations
  • Macule
  • Papule
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Naproxen treatment could be related to the listed above side effect(s).

Corneal Perforation
This is a report of the following Naproxen side effect(s):
  • Corneal Perforation
A 61-year-old female patient from US (weight: NA) presented with the following condition: rheumatoid arthritis and received a treatment with Naproxen (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Naproxen treatment could be associated with the listed above side effect(s).

Asthma
This Naproxen report was submitted by a 65-year-old female consumer from GB (weight: NA). The patient was diagnosed with: pain and Naproxen was administered (dosage: 500 Mg, Bid) starting: Jan 27, 2014. The consumer developed a set of symptoms:
  • Asthma
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Naproxen treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Rash, Blister, Stomatitis, Mouth Haemorrhage
This is a report of a possible correlation between Naproxen use and the following symptoms/side effect(s):
  • Rash
  • Blister
  • Stomatitis
  • Mouth Haemorrhage
which could contribute to an assessment of Naproxen risk profile.A 68-year-old female consumer from US (weight: NA) was suffering from arthropathy and was treated with Naproxen (dosage: 2 Pills Daily With Meals) starting Nov 13, 2013.Other concurrent medications:
  • Premarin
  • Spironolact
  • Calcium W/ Vitamin D
  • Glucosamine W/ Chondroitin
  • Zolpidem


Skin Exfoliation, Dry Skin, Pain Of Skin, Discomfort
A 40-year-old female patient from GB (weight: NA) presented with the following symptoms: back pain and after a treatment with Naproxen (dosage: 1000 Mg, Unk) experienced the following side effect(s):
  • Skin Exfoliation
  • Dry Skin
  • Pain Of Skin
  • Discomfort
The treatment was started on Dec 01, 2013. Naproxen was used in combination with the following drugs:
  • Omeprazole (20 Mg, Unk)
  • Zapain
  • Codeine
  • Ibuprofen
  • Tramadol
  • Gabapentin
  • Levothyroxine
  • Magnesium
This report could alert potential Naproxen consumers.

Photosensitivity Reaction
In this report, a 52-year-old male patient from US (weight: NA) was affected by a possible Naproxen side effect.The patient was diagnosed with NA. After a treatment with Naproxen (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Photosensitivity Reaction
The following simultaneously used drugs could have led to this reaction:
  • Cymbalta
  • Abilify
  • Seroquel
  • Lamictal
The findings here stress that side effects should be taken into consideration when evaluating a Naproxen treatment.

Gastrointestinal Haemorrhage, Haemoglobin Decreased
This is a report of a 66-year-old male patient from US (weight: NA), who used Naproxen (dosage: NA) for a treatment of pain. After starting a treatment on May 01, 2013, the patient experienced the following side effect(s):
  • Gastrointestinal Haemorrhage
  • Haemoglobin Decreased
The following drugs could possibly have interacted with the Naproxen treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Naproxen treatment could be related to side effect(s), such as Gastrointestinal Haemorrhage, Haemoglobin Decreased.

Skin Exfoliation, Dry Skin, Pain Of Skin, Discomfort
This skin exfoliation side effect was reported by a health professional from GB. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: back pain. The patient was prescribed Naproxen (dosage: Unk), which was started on Dec 01, 2013. Concurrently used drugs:
  • Omeprazole (Unk)
  • Zapain (Unk)
  • Codeine (Unk)
  • Ibuprofen (Unk)
  • Tramadol (Unk)
  • Gabapentin (Unk)
  • Levothyroxine (Unk)
  • Magnesium (Unk)
When starting to take Naproxen the consumer reported the following symptoms:
  • Skin Exfoliation
  • Dry Skin
  • Pain Of Skin
  • Discomfort
These side effects may potentially be related to Naproxen.

Dyspnoea
This is a Naproxen side effect report of a 62-year-old male patient (weight:NA) from GB, suffering from the following symptoms/conditions: NA, who was treated with Naproxen (dosage:NA, start time: Nov 20, 2013), combined with:
  • Calcipotriol (Unk)
  • Dovobet (Unk)
  • Beconase (Unk)
, and developed a serious reaction and a dyspnoea side effect. The patient presented with:
  • Dyspnoea
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Naproxen treatment in male patients suffering from NA, resulting in dyspnoea.

Haemorrhage, Hypopnoea
This report suggests a potential Naproxen Sodium 220 Mg 368 haemorrhage side effect(s) that can have serious consequences. A female patient from US (weight:NA) was diagnosed with the following health condition(s): back pain and used Naproxen Sodium 220 Mg 368 (dosage: 440 Mg, Qd) starting 201308. Soon after starting Naproxen Sodium 220 Mg 368 the patient began experiencing various side effects, including:
  • Haemorrhage
  • Hypopnoea
Drugs used concurrently:
  • 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)
The patient was hospitalized. Although Naproxen Sodium 220 Mg 368 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as haemorrhage, may still occur.

Asthma
This asthma problem was reported by a health professional from GB. A 65-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): pain.On Jan 27, 2014 a consumer started treatment with Naproxen 250mg 16028/0144 (dosage: 500 Mg, Bid). The following drugs/medications were being taken at the same time: NA. When commencing Naproxen 250mg 16028/0144, the patient experienced the following unwanted symptoms /side effects:
  • Asthma
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as asthma, may become evident only after a product is in use by the general population.

Discomfort, Dry Skin, Pain Of Skin, Skin Exfoliation
This is a Naproxen side effect report of a 40-year-old female patient (weight: NA) from GB. The patient developed the following symptoms/conditions: back pain and was treated with Naproxen (dosage: NA) starting Dec 01, 2013. Concurrently used drugs:
  • Omeprazole
  • Zapain
  • Tramadol
  • Codeine
  • Gabapentin
  • Ibuprofen
  • Levothyroxine
  • Magnesium
Soon after that, the consumer experienced the following of symptoms:
  • Discomfort
  • Dry Skin
  • Pain Of Skin
  • Skin Exfoliation
This opens a possibility that Naproxen could cause discomfort and that some female patients may be more susceptible.

Rectal Haemorrhage, Renal Failure Acute
A male patient (weight: NA) from US with the following symptoms: osteoarthritis started Naproxen treatment (dosage: NA) on Sep 15, 2012. Soon after starting Naproxen treatment, the consumer experienced several side effects, including:
  • Rectal Haemorrhage
  • Renal Failure Acute
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Naproxen side effects, such as rectal haemorrhage.

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 (dosage: NA), which was started on Dec 01, 2013. Concurrently used drugs:
  • Omeprazole
  • Codeine
  • Gabapentin
  • Ibuprofen
  • Levothyroxine
  • Selenium
  • Tramadol
  • Zapain
.When starting to take Naproxen the consumer reported symptoms, such as:
  • Discomfort
  • Dry Skin
  • Pain Of Skin
  • Skin Exfoliation
These side effects may potentially be related to Naproxen.

Chest Discomfort
This is a report of a 31-year-old male patient (weight: NA) from GB, suffering from the following 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). The consumer presented with:
  • Chest Discomfort
which developed 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.

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, Loss Of Consciousness, Blood Creatinine Increased, Blood Magnesium Decreased, Haematocrit Decreased, Haemoglobin Decreased, Red Blood Cell Count Decreased, Local Swelling 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. Soon 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 Swelling
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.

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 commencing Naproxen 250mg 16028/0144, the patient experienced the following unwanted symptoms/side effects:
  • Dyspnoea
Although 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.

Chest Discomfort
This is a report of a 31-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: NA and was treated with Naproxen (dosage: Unk) starting Jan 16, 2014. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Chest Discomfort
This opens a possibility that Naproxen treatment could cause the above reactions, including chest discomfort, and some male subjects may be more susceptible.

Anaphylactic Reaction
A 36-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: fibromyalgia,tuberculin test started Naproxen treatment (dosage: NA) on NS. Soon after starting Naproxen treatment, the subject experienced various side effects, including:
  • Anaphylactic Reaction
Concurrently used drugs:
  • Purified Protein Derivative
  • Neurotropin
  • Antidepressant
  • Thyroid Hormone Preparation
  • Vitamin Preparation
  • Contraceptives
This finding indicates that some female patients could be more vulnerable to Naproxen.

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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

    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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    Yes, Moderate
    Yes, Minor
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    How Effective is Naproxen for You?

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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]

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