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Naproxen (Naproxen) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short‑term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see CLINICAL PHARMACOLOGY).

In controlled clinical trials with about 80 pediatric patients and in well‑monitored, open‑label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo

Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura

Special Senses: tinnitus*, visual disturbances, hearing disturbances

Cardiovascular: edema*, palpitations

General: dyspnea*, thirst

[* Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.]

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in < 1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, peptic ulceration

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (female): infertility

In patients taking NSAIDs, the following adverse experiences have also been reported in < 1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria



REPORTS OF SUSPECTED NAPROXEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Naproxen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Naproxen side effects / adverse reactions in 69 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03

Patient: 69 year old female

Reactions: Haemoglobin Decreased, Upper Gastrointestinal Haemorrhage, Gastric Ulcer

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Fluoxetine
    Dosage: 20 mg
    Indication: Depression

Naproxen
    Dosage: 500 mg; po
    Administration route: Oral
    Indication: Arthritis
    Start date: 1997-12-24
    End date: 2011-09-05

Other drugs received by patient: Imipramine; Tolterodine Tartrate; Acetaminophen and Codeine Phosphate; Levothyroxine Sodium



Possible Naproxen side effects / adverse reactions in 53 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03

Patient: 53 year old female

Reactions: Malaise, Anaemia, Pancytopenia, Dizziness

Suspect drug(s):
Naproxen
    Dosage: 500 mg; bid; po
    Administration route: Oral
    Indication: Joint Injury
    Start date: 2011-06-19
    End date: 2011-06-30

Chloramphenicol
    Indication: Ocular Hyperaemia
    Start date: 2011-07-06

Other drugs received by patient: Prempak; Bendroflumethiazide; Enalapril Maleate; Hypromellose



Possible Naproxen side effects / adverse reactions in 46 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: 46 year old male

Reactions: Pseudoporphyria

Suspect drug(s):
Naproxen

Other drugs received by patient: Pregabalin; Floxacillin Sodium; Omeprazole; Infumorph



See index of all Naproxen side effect reports >>

Drug label data at the top of this Page last updated: 2008-02-19

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