Naprosyn (Naproxen Sodium) - 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 [Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.] , 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

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 erythematoses, 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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO NAPROSYN

Possible Naprosyn side effects / adverse reactions in 49 year old male

Reported by a physician from Germany on 2007-01-10

Patient: 49 year old male

Reactions: Abdominal Pain, Haemoglobin Decreased, Rectal Haemorrhage

Adverse event resulted in: hospitalization

Suspect drug(s):
Naprosyn

Possible Naprosyn side effects / adverse reactions in 73 year old female

Reported by a physician from United States on 2007-01-19

Patient: 73 year old female

Reactions: Gastrointestinal Haemorrhage, Pain, Dyspnoea Exertional, Haematocrit Decreased, Fatigue, Iron Deficiency Anaemia, Pulmonary Oedema, Muscle Spasms, Hiatus Hernia, Stomach Discomfort, Occult Blood Positive, Haemoglobin Decreased, Syncope, Diverticulum, Ventricular Tachycardia, Suicide Attempt, Asthenia, Depressed Mood

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Aleve
    Dosage: total daily dose: 880 mg unit dose: 220 mg
    Administration route: Oral
    Indication: Arthralgia

Motrin
    Dosage: total daily dose: 2400 mg unit dose: 800 mg
    Indication: Osteoarthritis

Naprosyn
    Indication: Osteoarthritis

Possible Naprosyn side effects / adverse reactions in 35 year old female

Reported by a pharmacist from Canada on 2007-02-20

Patient: 35 year old female weighing 94.0 kg (206.8 pounds)

Reactions: Burning Sensation, Speech Disorder, Dyspnoea, Tongue Oedema, Blindness Transient

Suspect drug(s):
Flagyl
    Start date: 2002-05-20
    End date: 2002-05-22

Tylenol W/ Codeine NO. 3
    Dosage: dose: 1.5 dosage form
    Start date: 2002-05-21
    End date: 2002-05-22

Naprosyn
    Administration route: Oral
    Start date: 2002-05-20
    End date: 2002-05-22

Other drugs received by patient: Gentamicin Sulfate; Methyldopa; Docusate Sodium; Acetaminophen