Toradol (Ketorolac Tromethamine) - Side Effects and Adverse Reactions

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.

• 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 (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

REPORTS OF SUSPECTED TORADOL SIDE EFFECTS / ADVERSE REACTIONS

Possible Toradol side effects / adverse reactions in 40 year old female

Reported by a pharmacist from United States on 2011-10-06

Patient: 40 year old female weighing 109.4 kg (240.7 pounds)

Reactions: Lung Abscess, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Vancomycin
    Dosage: 1.5 g varies iv
    Indication: Sepsis
    Start date: 2011-05-11
    End date: 2011-05-14

Vancomycin
    Dosage: 1.5 g varies iv
    Indication: Empyema
    Start date: 2011-05-11
    End date: 2011-05-14

Toradol
    Dosage: 15mg q6 x 4 iv
    Indication: Pain
    Start date: 2011-05-12
    End date: 2011-05-13

Other drugs received by patient: Coumadin; Percocet

Possible Toradol side effects / adverse reactions in 49 year old female

Reported by a pharmacist from United States on 2011-10-06

Patient: 49 year old female weighing 81.8 kg (180.0 pounds)

Reactions: Hypersensitivity

Adverse event resulted in: hospitalization

Suspect drug(s):
Morphine
    Dosage: various prn iv recent
    Indication: Procedural Pain

Dilaudid
    Dosage: recent
    Indication: Procedural Pain

Toradol
    Dosage: 30 q 6h prn iv recent
    Indication: Procedural Pain

Other drugs received by patient: Flagyl; Levaquin; VIT D; Zyrtec; Calcium + VIT D

Possible Toradol side effects / adverse reactions in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-12-16

Patient: 77 year old male

Reactions: Duodenal Ulcer Haemorrhage, Blood Creatine Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Toradol
    Dosage: daily dose 10 gtt
    Administration route: Oral
    Indication: Pain
    Start date: 2011-09-22
    End date: 2011-11-22

Aspirin
    Dosage: 100 mg, qd
    Administration route: Oral
    Start date: 2001-01-01
    End date: 2011-11-22

Other drugs received by patient: Triatec HCT; Lopressor; Esapent; Teraprost; Lasix