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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO TORADOL

Possible Toradol side effects / adverse reactions in 89 year old male

Reported by a pharmacist from United States on 2007-01-09

Patient: 89 year old male

Reactions: HIP Fracture, Refusal of Treatment by Patient, Respiratory Failure, Blood Creatine Increased, Fall, Cardiac Failure Congestive

Adverse event resulted in: death

Suspect drug(s):
Toradol
    Dosage: 15 mg q6h iv

Captopril
    Dosage: 50 mg qid po
    Administration route: Oral

Possible Toradol side effects / adverse reactions in 37 year old female

Reported by a physician from United States on 2007-02-09

Patient: 37 year old female weighing 64.0 kg (140.8 pounds)

Reactions: Pelvic Infection, Fungal Infection, Ovarian Cyst, Platelet Count Decreased, Peritonitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Mirena
    Dosage: 20 a?g, cont
    Indication: Contraception
    Start date: 2005-07-01
    End date: 2006-12-02

Toradol
    Start date: 2006-12-01
    End date: 2006-12-01

Possible Toradol side effects / adverse reactions in 44 year old female

Reported by a physician from Canada on 2007-02-19

Patient: 44 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Neuropathy, Paranoia, Tremor, Anxiety, Malaise, Diarrhoea, Crying, Panic Reaction

Suspect drug(s):
Toradol

Other drugs received by patient possibly interacting with the suspect drug:
Amitriptyline HCL
    Indication: Drug USE FOR Unknown Indication

Topamax
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Oxycodone Hydrochloride and Acetaminophen
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Gabapentin; Aspirin; Elavil; Oxycodone HCL