Ibuprofen (Page 3 of 5)

Pregnancy

Teratogenic effects: Pregnancy Category C
Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Ibuprofen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic effects
Because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided.

Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of ibuprofen tablets on labor and delivery in pregnant women are unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established.

Geriatric Use

As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

ADVERSE REACTIONS

The most frequent type of adverse reaction occurring with ibuprofen tablets 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 tablets were 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 the table. 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 the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets 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 the table.

*
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 tablets. (Those reactions occurring in less than 3% of the patients are unmarked.)

Incidence Greater Than 1% (but less than 3%) Probable Causal Relationship

Precise Incidence Unknown (but less than 1%) Probable Causal Relationship *

Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown**

GASTROINTESTINAL

Nausea , epigastric pain , heartburn , diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of Gl 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 liability, 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

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 tests

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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