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Relafen (Nabumetone) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reaction information was derived from blinded-controlled and open-labelled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies.

Of the 1,677 patients who received RELAFEN during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer.

The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.

Incidence≥1%—Probably Causally Related

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness*, headache*, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus*, rash*.

Special Senses: Tinnitus*.

Miscellaneous: Edema*.

*Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked.

Incidence <1%—Probably Causally Related

Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.

Central Nervous System: Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.

Dermatologic: Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Cardiovascular: Vasculitis.

Metabolic: Weight gain.

Respiratory: Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.

Genitourinary: Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure.

Special Senses: Abnormal vision.

Hematologic/Lymphatic: Thrombocytopenia.

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioneurotic edema.

Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.

Incidence <1%—Causal Relationship Unknown

Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.

Central Nervous System: Nightmares.

Dermatologic: Acne, alopecia.

Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.

Respiratory: Asthma, cough.

Genitourinary: Dysuria, hematuria, impotence, renal stones.

Special Senses: Taste disorder.

Body as a Whole: Fever, chills.

Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia.

Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.



REPORTS OF SUSPECTED RELAFEN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Relafen side effects / adverse reactions in 50 year old female

Reported by a physician from United States on 2011-11-10

Patient: 50 year old female

Reactions: Hypoaesthesia

Suspect drug(s):
Hyzaar
    Dosage: unk

Lyrica
    Dosage: 75 mg, 2x/day
    Indication: Fibromyalgia

Norflex
    Dosage: unk

Relafen
    Dosage: unk



Possible Relafen side effects / adverse reactions in 79 year old male

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 79 year old male

Reactions: Contusion, Hyperaesthesia, Diarrhoea, Laceration, Wound Haemorrhage

Suspect drug(s):
Lovaza
    Dosage: 4cap per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Relafen
    Dosage: 500mg per day
    Administration route: Oral
    Indication: Osteoarthritis

Other drugs received by patient: Cardura; Unknown; Lisinopril; Folic Acid; Aspirin; Quinine Sulfate; Synthroid; Proscar; Cartia XT; Multi-Vitamin; Calcium



Possible Relafen side effects / adverse reactions in 53 year old male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: 53 year old male weighing 145.3 kg (319.6 pounds)

Reactions: Back Pain, Drug Ineffective, Neck Pain, Blood Testosterone Decreased, Injury, Hyperhidrosis

Suspect drug(s):
Androgel
    Dosage: 2 pumps per day
    Indication: Blood Testosterone Decreased
    Start date: 2012-04-01

Cyclobenazprine
    Indication: Neck Pain

Cyclobenazprine
    Indication: Musculoskeletal Pain
    Start date: 2012-04-01

Indocin
    Indication: Musculoskeletal Pain
    Start date: 2012-04-01

Indocin
    Indication: Neck Pain

Relafen
    Indication: Neck Pain

Relafen
    Indication: Musculoskeletal Pain
    Start date: 2012-04-01

Symbicort
    Indication: Sleep Apnoea Syndrome
    Start date: 2012-04-01

Other drugs received by patient: Unknown Antibiotic; Unknown Antibiotic



See index of all Relafen side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-31

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