Ketorolac Side Effects
Brand Names: Toradol
Please note - some side effects for Ketorolac 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).
Side Effects of Ketorolac - for the Consumer
Ketorolac
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ketorolac:
Seek medical attention right away if any of these SEVERE side effects occur when using Ketorolac:Constipation; diarrhea; dizziness; drowsiness; gas; headache; indigestion; itching; mouth sores; nausea; pain at the injection site; purple patches under the skin; stomach fullness; stomach pain; sweating; swelling; upset stomach; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; bleeding; dark urine or pale stools; decreased urination or blood in the urine; fainting; fluid retention; hallucinations; meningitis; persistent stomach/abdominal pain; pounding in the chest; psychosis; rectal bleeding; seizures; shortness of breath; stomach perforation; tightness in chest; tremors; ulcers; unusual bleeding or bruising; unusual fatigue; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Ketorolac Drops
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ketorolac Drops:
Seek medical attention right away if any of these SEVERE side effects occur when using Ketorolac Drops:Blurred vision; eye irritation; eye redness; headache; inflammation of the eye; stinging and burning of the eye while applying; swelling of the cornea and iris.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continuous pain, burning, stinging, redness, or swelling around the eyes; infection in the eye; unusual bleeding; vision changes.
Ketorolac Tromethamine Drops
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ketorolac Tromethamine Drops:
Seek medical attention right away if any of these SEVERE side effects occur when using Ketorolac Tromethamine Drops:Blurred vision; headache; increased tear production; swelling of the cornea and iris; temporary burning, irritation, pain, redness, stinging, or swelling of the eye.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continuous pain, burning, irritation, stinging, redness, or swelling around the eyes; infection in the eye; unusual bleeding; vision changes.
Ketorolac Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ketorolac Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Ketorolac Tablets:Constipation; diarrhea; dizziness; drowsiness; gas; headache; indigestion; mouth sores; nausea; purple patches under the skin; stomach fullness; stomach pain; sweating; swelling; vomiting.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; dark urine or pale stools; fainting; fluid retention; hallucinations; meningitis; persistent stomach/abdominal pain; pounding in the chest; psychosis; rectal bleeding; seizures; severe and continuing nausea; shortness of breath; stomach perforation; tightness in chest; tremors; ulcers; unusual bleeding or bruising; unusual fatigue; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Ketorolac Side Effects - for the Professional
Ketorolac
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.
In patients taking Ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
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| Gastrointestinal (GI) experiences including: | ||
| Abdominal Pain* | Constipation/Diarrhea | Dyspepsia* |
| Flatulence | GI Fullness | GI Ulcers (gastric/duodenal) |
| Gross Bleeding/Perforation | Heartburn | Nausea* |
| Stomatitis | Vomiting | |
| Other experiences: | ||
| Abnormal Renal Function | Anemia | Dizziness |
| Drowsiness | Edema | Elevated Liver Enzymes |
| Headaches* | Hypertension | Increased Bleeding Time |
| Injection Site Pain | Pruritus | Purpura |
| Rashes | Tinnitus | Sweating |
Additional adverse experiences reported occasionally (<1% in patients taking Ketorolac tromethamine or other NSAIDs in clinical trials) include:
Body as a Whole: fever, infections, sepsis
Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope
Dermatologic: alopecia, photosensitivity, urticaria
Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis,glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding
Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia
Metabolic and Nutritional: weight change
Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise
Reproductive, female: infertility
Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis
Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss
Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention
Other rarely observed reactions (reported from post-marketing experience in patients taking Ketorolac tromethamine or other NSAIDs) are:
Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema, myalgia
Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis
Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell’s syndrome, bullous reactions including Stevens-Johnson Syndrome and toxic epidermal necrolysis
Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, postoperative wound hemorrhage (rarely requiring blood transfusion — see Boxed WARNING, WARNINGS, and PRECAUTIONS)
Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia
Nervous System: aseptic meningitis, convulsions, coma, psychosis
Respiratory: bronchospasm, respiratory depression, pneumonia
Special Senses: conjunctivitis
Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome
Post-Marketing Surveillance Study: A large post-marketing observational, nonrandomized study, involving approximately 10,000 patients receiving Ketorolac tromethamine IV or IM, demonstrated that the risk of clinically serious gastrointestinal (G.I.) bleeding was dose dependent. This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of Ketorolac tromethamine IV or IM.
| A. Adult Patients without History of PUB | ||||
| Age of Patients |
Total Daily Dose of Ketorolac Tromethamine IV/IM | |||
| ≤ 60 mg | > 60 to 90 mg | > 90 to 120 mg | > 120 mg | |
| < 65 years of age | 0.4% | 0.4% | 0.9% | 4.6% |
| ≥ 65 years of age | 1.2% | 2.8% | 2.2% | 7.7% |
| B. Adult Patients with History of PUB | ||||
| Age of Patients |
Total Daily Dose of Ketorolac Tromethamine IV/IM | |||
| ≤ 60 mg | > 60 to 90 mg | > 90 to 120 mg | > 120 mg | |
| < 65 years of age | 2.1% | 4.6% | 7.8% | 15.4% |
| ≥ 65 years of age | 4.7% | 3.7% | 2.8% | 25% |
Side Effects by Body System
Renal
Acute renal failure has been reported with short-term use of ketorolac, 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 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 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 therapy has also been reported.
TopMore Ketorolac resources
- ketorolac Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information
- Ketorolac Medfacts Consumer Leaflet (Wolters Kluwer)
- Ketorolac Prescribing Information (FDA)
- Toradol Prescribing Information (FDA)
- Toradol Advanced Consumer (Micromedex) - Includes Dosage Information
- Toradol Consumer Overview
- Toradol Detailed Consumer Information (PDR)
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