ADVERSE REACTIONS
Adverse reaction rates increase with higher doses of TORADOL. Practitioners should be alert for the severe complications of treatment with TORADOL, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see BOX WARNING, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION). These NSAID-related complications can be serious in certain patients for whom TORADOL is indicated, especially when the drug is used inappropriately. The Adverse Reactions Listed Below Were Reported in Clinical Trials as Probably Related to TORADOL:
- 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
Injection-site pain was reported by 2% of patients in multidose studies.
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 (see BOX WARNING and WARNINGS), angioedema, myalgia
Cardiovascular: hypotension, flushing
Dermatologic: Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticaria
Gastrointestinal: peptic ulceration, GI hemorrhage, GI perforation (see BOX WARNING and WARNINGS), melena, acute pancreatitis, hematemesis, esophagitis
Hemic and Lymphatic: postoperative wound hemorrhage (rarely requiring blood transfusion -- see BOX WARNING, WARNINGS, and PRECAUTIONS), thrombocytopenia, leukopenia
Hepatic: hepatitis, liver failure, cholestatic jaundice
Nervous System: convulsions, psychosis, aseptic meningitis
Respiratory: asthma, bronchospasm
Urogenital: acute renal failure (see BOX WARNING and WARNINGS), flank pain with or without hematuria and/or azotemia, interstitial nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome
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