A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Relafen Side Effects, and Drug Interactions - Nabumetone
Relafen Side Effects, and Drug Interactions - Nabumetone
SIDE EFFECTS
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 U.S.
clinical studies.
Of the 1677 patients who received nabumetone during U.S. clinical
trials, 1524 were treated for at least 1 month, 1327 for at least
3 months, 929 for at least a year and 750 for at least 2 years.
Over 300 patients have been treated for 5 years or longer.
The most frequently reported adverse reactions were related to
the gastrointestinal tract. They were diarrhea, dyspepsia
and abdominal pain.
Incidence ³1%¾Probably
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%¾Probably
Causally Related†
Gastrointestinal: Anorexia, cholestatic jaundice,
duodenal ulcer, dysphagia, gastric
ulcer, gastroenteritis, gastrointestinal
bleeding, increased appetite, liver
function abnormalities,
melena.
Central Nervous System: Asthenia, agitation, anxiety,
confusion, depression, malaise, paresthesia, tremor, vertigo.
Dermatologic: Bullous eruptions, photosensitivity,
urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis.
Cardiovascular: Vasculitis.
Metabolic: Weight gain.
Respiratory: Dyspnea, eosinophilic pneumonia
hypersensitivity pneumonitis.
Genitourinary: Albuminuria, azotemia, hyperuricemia,
interstitial nephritis, nephrotic
syndrome, vaginal bleeding.
Special Senses: Abnormal vision.
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%¾Causal Relationship
Unknown‡
Gastrointestinal: Bilirubinuria, duodenitis, eructation,
gallstones, gingivitis, glossitis, pancreatitis, rectal
bleeding.
Central Nervous System: Nightmares.
Dermatologic: Acne, alopecia, erythema multiforme,
Stevens-Johnson Syndrome.
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,
thrombocytopenia.
Metabolic/Nutritional: Hyperglycemia, hypokalemia,
weight loss.
‡Adverse reactions reported only in worldwide postmarketing experience
or in the literature, not seen in clinical
trials, are considered rarer and are italicized.
DRUG INTERACTIONS
In vitro studies have shown that, because of its affinity
for protein, 6MNA may displace other protein-bound drugs from their
binding site. Caution should be exercised when administering nabumetone
with warfarin since interactions have been seen with other NSAIDs.
Concomitant administration
of an aluminum-containing antacid
had no significant effect
in the bioavailability of 6MNA. When administered with food or milk,
there is more rapid absorption; however, the total amount of 6MNA
in the plasma is unchanged
(see CLINICAL PHARMACOLOGY, Pharmacokinetics)
.
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