Toradol IV / IM Side Effects

Generic name: ketorolac

Note: This document contains side effect information about ketorolac. Some of the dosage forms listed on this page may not apply to the brand name Toradol IV / IM.

Some side effects of Toradol IV / IM may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ketorolac: injectable solution, nasal spray, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ketorolac (the active ingredient contained in Toradol IV / IM) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ketorolac nasal and call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• slow heart rate;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• urinating less than usual or not at all;

• swelling, rapid weight gain; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of ketorolac may include:

• pain or irritation in your nose;

• runny nose;

• watery eyes;

• throat irritation;

• upset stomach, heartburn, constipation, diarrhea;

• mild rash; or

• headache, drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ketorolac: injectable solution, nasal spray, oral tablet

Renal

Acute renal failure has been reported with short-term use of ketorolac (the active ingredient contained in Toradol IV / IM) even with moderate doses. Hyperkalemia often accompanies acute renal failure. Chronic ketorolac exposure may result in transient increases in BUN and creatinine in 2% to 3% of patients. Renal papillary necrosis has also been reported after chronic ketorolac exposure in some animal studies.

Patients with preexisting renal disease, congestive heart failure, hypovolemia, hepatic cirrhosis, nephrotic syndrome, or hypoalbuminemia are at increased risk for acute renal failure during ketorolac therapy as renal function in these conditions is dependent upon renal prostaglandin synthesis. Risk versus benefit should be carefully weighed in such patients.

In addition, ketorolac may have renal-metabolic effects such as salt and water retention, inhibition of diuretic action, and hyperkalemia due to suppression of the renin-angiotensin-aldosterone system. These effects are similar to those reported with other nonsteroidal anti-inflammatory agents.

Renal failure associated with hemolytic uremic syndrome developed in a 58-year-old female treated for arthralgias with oral ketorolac. After a total dose of 30 mg the patient developed vomiting and bloody diarrhea. Three days later, the patient again developed nausea, vomiting, oliguria, facial and peripheral edema, and hypertension. Hemolytic anemia, thrombocytopenia, elevated lactate dehydrogenase, decreased fibrinogen, and renal failure were noted on laboratory evaluation. Treatment consisted of furosemide and supportive care. Eight days later, all laboratory values were within normal limits and the patient was well.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Renal side effects have included acute renal failure and flank pain. Oliguria, nephritis, hyperkalemia, hematuria, proteinuria, and urinary frequency have also been reported. Ketorolac has also been implicated in a case of hemolytic uremic syndrome.

Gastrointestinal

As with other nonsteroidal anti-inflammatory agents, gastrointestinal complaints are common in patients on ketorolac (the active ingredient contained in Toradol IV / IM) therapy. While these effects are usually mild in nature, serious gastrointestinal effects are reported, including peptic and colonic ulceration and gastrointestinal bleeding and perforation. Serious gastrointestinal bleeding may not be preceded by symptoms. While experience is limited, there is some indication that the risk of serious gastrointestinal effects increases with prolonged treatment with ketorolac. Thus, ketorolac is only recommended for the short-term management of pain.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Ketorolac should be used with caution in these patients.

Gastrointestinal side effects have included gastrointestinal pain (13%), nausea (12%), dyspepsia (12%), diarrhea, constipation, flatulence, stomatitis, rectal bleeding, and melena. More serious effects include peptic ulceration (including giant gastric and duodenal ulcers), and gastrointestinal bleeding and perforation. GI bleeding increased with larger doses, therapy duration longer than 5 days, and older patients. Pancreatitis and exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease) has also been reported.

Hematologic

Hematologic side effects have included purpura, thrombocytopenia, epistaxis, inhibition of platelet aggregation, increased bleeding time, leukopenia, and eosinophilia.

Hepatic

Hepatic side effects have included borderline increases in liver function tests in up to 15% of patients in clinical trials. However, significant increases (three times normal values) occur in less than 1% of patients. Hepatitis, liver failure, and cholestatic jaundice have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included dyspnea, asthma, wheezing, and pulmonary edema.

Nervous system

Nervous system side effects have included headache (17%), somnolence or drowsiness (3% to 9%), dizziness (3% to 9%), convulsions, vertigo, tremors, hallucinations, and euphoria. In addition, paresthesias, stupor, and hyperkinesia are reported; causality is unknown.

Cardiovascular

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Cardiovascular side effects have included edema, palpitations, vasodilation, hypotension, syncope, and pallor. In addition, blood pressure may be elevated by ketorolac which may have clinical relevance in patients with comorbid illnesses.

Dermatologic

Dermatologic side effects have included rash, pruritus, and urticaria. Exfoliative dermatitis has also been reported.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, bronchospasm, acute angioedema (including laryngeal and tongue edema), and fever. Lyell's syndrome, erythema multiforme, bullous reactions such Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.

Local

Local side effects associated with intramuscular injection of ketorolac (the active ingredient contained in Toradol IV / IM) include local pain, ecchymosis, bruising, hematoma, and tingling.

Ocular

Ocular side effects have included altered or blurred vision in less than 1% of patients.

Psychiatric

Psychiatric side effects have included depression, insomnia, abnormal dreams, and nervousness.

Other

Other side effects have included rare reports of tinnitus and hearing loss. Weight gain during long-term ketorolac (the active ingredient contained in Toradol IV / IM) therapy has also been reported.

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