Sprix 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 Sprix.
Some side effects of Sprix 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, tablet
Other dosage forms:
Along with its needed effects, ketorolac (the active ingredient contained in Sprix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ketorolac:More common
- Swelling of face, fingers, lower legs, ankles, and/or feet
- weight gain (unusual)
- Bruising (not at place of injection)
- high blood pressure
- skin rash or itching
- small, red spots on skin
- sores, ulcers, or white spots on lips or in mouth
- Abdominal or stomach pain, cramping, or burning that is severe
- bleeding from the rectum or bloody or black, tarry stools
- bloody or cloudy urine
- blue lips and fingernails
- blurred vision of other vision change
- burning, red, tender, thick, scaly, or peeling skin
- chest pain
- cough or hoarseness
- dark urine
- decrease in amount of urine that is sudden
- fast, irregular, noisy, or troubled breathing
- fever with severe headache, drowsiness, confusion, and stiff neck or back
- fever with or without chills or sore throat
- hallucinations (seeing, hearing, or feeling things that are not there)
- hearing loss
- increase in amount of urine or urinating often
- light-colored stools
- loss of appetite
- low blood pressure
- mood changes or unusual behavior
- muscle cramps or pain
- nausea, heartburn, or indigestion that is severe and continues
- pain in lower back and/or side
- pain, tenderness, or swelling in the upper stomach area
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or eyes
- ringing or buzzing in ears
- runny nose
- severe restlessness
- shortness of breath
- swollen or painful glands
- swollen tongue
- thirst that continues
- tightness in the chest with or without wheezing
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Some side effects of ketorolac may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Abdominal or stomach pain (mild or moderate)
- bruising at place of injection
- Bloating or gas
- burning or pain at place of injection
- feeling of fullness in abdominal or stomach area
- increased sweating
For Healthcare Professionals
Applies to ketorolac: injectable solution, nasal spray, oral tablet
Acute renal failure has been reported with short-term use of ketorolac (the active ingredient contained in Sprix) 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.
As with other nonsteroidal anti-inflammatory agents, gastrointestinal complaints are common in patients on ketorolac (the active ingredient contained in Sprix) 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 side effects have included purpura, thrombocytopenia, epistaxis, inhibition of platelet aggregation, increased bleeding time, leukopenia, and eosinophilia.
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 side effects have included dyspnea, asthma, wheezing, and pulmonary edema.
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.
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 side effects have included rash, pruritus, and urticaria. Exfoliative dermatitis has also been reported.
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 side effects associated with intramuscular injection of ketorolac (the active ingredient contained in Sprix) include local pain, ecchymosis, bruising, hematoma, and tingling.
Ocular side effects have included altered or blurred vision in less than 1% of patients.
Psychiatric side effects have included depression, insomnia, abnormal dreams, and nervousness.
Other side effects have included rare reports of tinnitus and hearing loss. Weight gain during long-term ketorolac (the active ingredient contained in Sprix) therapy has also been reported.
More about Sprix (ketorolac)
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