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
Motrin Side Effects, and Drug Interactions - Ibuprofen
Motrin Side Effects, and Drug Interactions - Ibuprofen
SIDE EFFECTS
Tablets and Suspension
The most frequent type of adverse
reaction occurring with ibuprofen
is gastrointestinal. In controlled clinical
trials, the percentage of patients reporting one or more gastrointestinal
complaints ranged from 4% to 16%.
In controlled studies when ibuprofen
was compared to aspirin and
indomethacin in equally effective doses, the overall incidence
of gastrointestinal
complaints was about half that seen in either the aspirin- or indomethacin-treated
patients.
Adverse reactions observed during controlled clinical
trials at an incidence greater than 1% are listed in TABLE 1A and TABLE
1B. Those reactions listed in column
one encompass observations in approximately 3,000 patients. More than
500 of these patients were treated for periods of at least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 were reported
in controlled clinical trials
and from marketing experience. These reactions have been divided into
two categories: column two
of TABLE 1A and TABLE 1B lists reactions with therapy with ibuprofen
where the probability of a causal relationship exists; for the reactions
in column three, a causal relationship
with ibuprofen has not been
established.
Reported side effects were higher
at doses of 3200 mg/day than at doses of 2400 mg or less per
day in clinical trials of
patients with rheumatoid arthritis. The increases in incidence
were slight and still within the ranges reported in TABLE 1A and TABLE
1B.
|
TABLE 1A
|
| Incidence Greater than 1% (but less than 3%) |
Precise Incidence Unknown (but less than 1%) |
Precise Incidence Unknown (but less than 1%) |
| Probable Causal Relationship |
Probable Causal Relationship* |
Causal Relationship Unknown* |
| Gastrointestinal |
| Nausea†, epigastric pain†, heartburn†, diarrhea, abdominal
distress, nausea and
vomiting, indigestion, constipation, abdominal
cramps or pain, fullness of GI
tract (bloating and flatulence) |
Gastric or duodenal
ulcer with bleeding
and/or perforation, gastrointestinal hemorrhage, melena, gastritis,
hepatitis, jaundice, abnormal liver function
tests; pancreatitis |
|
| Central Nervous System |
| Dizziness†, headache, nervousness |
Depression, insomnia, confusion, emotional lability,
somnolence, aseptic meningitis
with fever and coma
(See PRECAUTIONS) |
Paresthesias, hallucinations, dream
abnormalities, pseudotumor cerebri |
| Dermatologic |
| Rash† (including maculopapular
type), pruritus |
Vesiculobullous eruptions, urticaria, erythema
multiforme, Stevens-Johnson syndrome, alopecia |
Toxic epidermal necrolysis, photoallergic skin
reactions |
| Special Senses |
| Tinnitus |
Hearing loss, amblyopia
(blurred and/or diminished vision, scotomata and/or changes in color
vision) (see PRECAUTIONS) |
Conjunctivitis, diplopia, optic
neuritis, cataracts |
| * Reactions are classified under "Probable
Causal Relationship (PCR)" if there has been one positive
rechallenge or if three or more cases occur which might be causally
related. Reactions are classified under "Causal Relationship
Unknown" if seven or more events have been reported but
the criteria for PCR have
not been met. |
| † Reactions occurring in 3% to 9%
of patients treated with ibuprofen. (Those reactions occurring in
less than 3% of the patients are unmarked.) |
|
TABLE 1B
|
| Incidence Greater than 1% (but less than 3%) |
Precise Incidence Unknown (but less than 1%) |
Precise Incidence Unknown (but less than 1%) |
| Probable Causal Relationship |
Probable Causal Relationship* |
Causal Relationship Unknown* |
| Hematologic |
| |
Neutropenia, agranulocytosis, aplastic anemia, hemolytic
anemia (sometimes Coombs positive), thrombocytopenia
with or without purpura, eosinophilia, decreases in hemoglobin
and hematocrit (see
PRECAUTIONS) |
Bleeding episodes (e.g., epistaxis, menorrhagia) |
| Metabolic/Endocrine |
| Decreased appetite |
|
Gynecomastia, hypoglycemic reaction, acidosis |
| Cardiovascular |
| Edema, fluid
retention (generally
responds promptly to drug discontinuation) (see PRECAUTIONS) |
Congestive heart
failure in patients
with marginal cardiac
function, elevated blood
pressure, palpitations |
Arrhythmias (sinus tachycardia, sinus
bradycardia) |
| Allergic |
| |
Syndrome of abdominal
pain, fever, chills, nausea
and vomiting; anaphylaxis; bronchospasm
(see CONTRAINDICATIONS) |
Serum sickness, lupus
erythematosus syndrome, Henoch-Schonlein vasculitis, angioedema |
| Renal |
| |
Acute renal
failure (see PRECAUTIONS),
decreased creatinine
clearance, polyuria, azotemia, cystitis, hematuria |
Renal papillary necrosis |
| Miscellaneous |
| |
Dry eyes and mouth, gingival
ulcer, rhinitis |
|
| * Reactions are classified under "Probable
Causal Relationship (PCR)" if there has been one positive
rechallenge or if three or more cases occur which might be causally
related. Reactions are classified under "Causal Relationship
Unknown" if seven or more events have been reported but
the criteria for PCR have
not been met. |
Suspension
In a 12-week comparison of ibuprofen
children's suspension (n=45)
and aspirin (n=47) in children with juvenile
arthritis, the most common adverse experiences were also gastrointestinal
in nature, usually of mild severity. Abdominal pain
of possible drug relationship
was reported in about 25% of patients on ibuprofen
and/or aspirin; other possibly drug-related effects associated with the
digestive system
were reported in 42% of the children taking ibuprofen
and in 70% of those taking aspirin.
DRUG INTERACTIONS
Coumarin-Type Anticoagulants: Several short-term controlled
studies failed to wshow that ibuprofen
significantly affected prothrombin times or a variety of other clotting
factors when administered to individuals on coumarin-type anticoagulants.
However, because bleeding
has been reported when ibuprofen
and other nonsteroidal anti-inflammatory agents have been administered
to patients on coumarin-type anticoagulants, the physician should be cautious
when administering ibuprofen
to patients on anticoagulants.
Aspirin: Animal studies wshow
that aspirin given with nonsteroidal
anti-inflammatory agents, including ibuprofen, yields a net decrease in
anti-inflammatory activity with lowered blood
levels of the non-aspirin drug. Single dose
bioavailability studies in normal
volunteers have failed to wshow
an effect of aspirin
on ibuprofen blood
levels. Correlative clinical studies have not been performed.
Methotrexate: Ibuprofen, as well as other nonsteroidal
anti-inflammatory drugs, probably reduces the tubular
secretion of methotrexate
based on in vitro studies in rabbit kidney slices. This may indicate
that ibuprofen could enhance
the toxicity of methotrexate. Caution should be used if ibuprofen
is administered concomitantly with methotrexate.
H-2 Antagonists: In studies with human
volunteers, co-administration of cimetidine
or ranitidine with ibuprofen
had no substantive effect on
ibuprofen serum concentrations.
Furosemide: Clinical studies, as well as random observations,
have shown that ibuprofen
can reduce the natriuretic
effect of furosemide and thiazides
in some patients. This response
has been attributed to inhibition of renal
prostaglandin synthesis.
During concomitant therapy
with ibuprofen, the patient
should be observed closely for signs of renal
failure (see PRECAUTIONS,
General, Renal Effects), as well as to assure diuretic
efficacy.
Lithium: Ibuprofen produced an elevation
of plasma lithium levels and
a reduction in renal
lithium clearance
in a study of eleven normal volunteers. The mean
minimum lithium
concentration increased
15% and the renal clearance
of lithium was decreased by
19% during this period of concomitant
drug administration.
This effect has been attributed
to inhibition of renal
prostaglandin synthesis by ibuprofen. Thus, when ibuprofen
and lithium are administered
concurrently, subjects should be observed carefully for signs of lithium
toxicity. (Read circulars for lithium
preparation before use
of such concurrent therapy).
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