Sprix Side Effects
Generic Name: ketorolac
Note: This page contains side effects data for the generic drug ketorolac. It is possible that some of the dosage forms included below may not apply to the brand name Sprix.
It is possible that some side effects of Sprix may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to ketorolac: injectable, solution, tablet
Other dosage forms:
As well as its needed effects, ketorolac (the active ingredient contained in Sprix) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking ketorolac, check with your doctor immediately: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 ketorolac side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.
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.
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.
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.
Cardiovascular side effects have included edema, palpitations, vasodilation, hypotension, syncope, and pallor. In addition, blood pressure may be elevated by ketorolac (the active ingredient contained in Sprix) which may have clinical relevance in patients with comorbid illnesses.
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.
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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