Ketorlac Side Effects

Please note - some side effects for Ketorlac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

For the professional

Ketorlac

Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions, and liver failure. These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.

The adverse reactions listed below were reported in clinical trials as probably related to ketorolac tromethamine.

■ INCIDENCE GREATER THAN 1%

[Percentage of incidence in parentheses for those events reported in 3% or more patients]

Body as a Whole: edema (4%).

Cardiovascular: hypertension.

Dermatologic: pruritus, rash.

Gastrointestinal: nausea (12%), dyspepsia (12%), gastrointestinal pain (13%), diarrhea (7%), constipation, flatulence, gastrointestinal fullness, vomiting, stomatitis.

Hemic and Lymphatic: purpura.

Nervous System: headache (17%), drowsiness (6%), dizziness (7%), sweating.

■ INCIDENCE 1% OR LESS

Body as a Whole: weight gain, fever, infections, asthenia.

Cardiovascular: palpitation, pallor, syncope.

Dermatologic: urticaria.

Gastrointestinal: gastritis, rectal bleeding, eructation, anorexia, increased appetite.

Hemic and Lymphatic: epistaxis, anemia, eosinophilia.

Nervous System: tremors, abnormal dreams, hallucinations, euphoria, extrapyramidal symptoms, vertigo, paresthesia, depression, insomnia, nervousness, excessive thirst, dry mouth, abnormal thinking, inability to concentrate, hyperkinesis, stupor.

Respiratory: dyspnea, pulmonary edema, rhinitis, cough.

Special Senses: abnormal taste, abnormal vision, blurred vision, tinnitus, hearing loss.

Urogenital: hematuria, proteinuria, oliguria, urinary retention, polyuria, increased urinary frequency.

The following adverse events were reported from postmarketing experience.

Body as a Whole: hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema, myalgia.

Cardiovascular: hypotension and flushing.

Dermatologic: Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculo-papular rash, urticaria.

Gastrointestinal: peptic ulceration, GI hemorrhage, GI perforation, melena, acute pancreatitis.

Hemic and Lymphatic: postoperative wound hemorrhage, rarely requiring blood transfusion, thrombocytopenia, leukopenia.

Hepatic: hepatitis, liver failure, cholestatic jaundice.

Nervous System: convulsions, psychosis, aseptic meningitis.

Respiratory: asthma, bronchospasm.

Urogenital: acute renal failure, flank pain with or without hematuria and/or azotemia, nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome.

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