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)
Less common
  • 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
Rare
  • 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
  • convulsions
  • cough or hoarseness
  • dark urine
  • decrease in amount of urine that is sudden
  • fainting
  • 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
  • hives
  • 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
  • nosebleeds
  • 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
  • diarrhea
  • dizziness
  • drowsiness
  • headache
  • indigestion
  • nausea
Less common or rare
  • Bloating or gas
  • burning or pain at place of injection
  • constipation
  • feeling of fullness in abdominal or stomach area
  • increased sweating
  • vomiting

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 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.[Ref]

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.[Ref]

Gastrointestinal

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.[Ref]

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.[Ref]

Hematologic

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

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.[Ref]

Respiratory

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

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.[Ref]

Cardiovascular

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.[Ref]

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.[Ref]

Dermatologic

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

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.[Ref]

Local

Local side effects associated with intramuscular injection of ketorolac (the active ingredient contained in Sprix) include local pain, ecchymosis, bruising, hematoma, and tingling.[Ref]

Ocular

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

Psychiatric

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

Other

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.[Ref]

References

1. Kelley M, Bastani B "Ketorolac-induced acute renal failure and hyperkalemia." Clin Nephrol 44 (1995): 276-7

2. Fong J, Gora ML "Reversible renal insufficiency following ketorolac therapy." Ann Pharmacother 27 (1993): 510-2

3. Perneger TV, Whelton PK, Klag MJ "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med 331 (1994): 1675-9

4. Pearce CJ, Gonzalez FM, Wallin JD "Renal failure and hyperkalemia associated with ketorolac tromethamine." Arch Intern Med 153 (1993): 1000-2

5. Litvak KM, McEvoy GK "Ketorolac, an injectable nonnarcotic analgesic." Clin Pharm 9 (1990): 921-35

6. Quan DJ, Kayser SR "Ketorolac induced acute renal failure following a single dose." J Toxicol Clin Toxicol 32 (1994): 305-9

7. Buller GK, Perazella MA "Acute renal failure and ketorolac." Ann Intern Med 127 (1997): 493

8. Feldman HI, Kinman JL, Berlin JA, et al. "Parenteral ketorolac: the risk for acute renal failure." Ann Intern Med 126 (1997): 193-9

9. Randi ML, Tison T, Luzzatto G "Haemolytic uraemic syndrome during treatment with ketorolac trometamol." BMJ 306 (1993): 186

10. Aitken HA, Burns JW, McArdle CS, Kenny GNC "Effects of ketorolac trometamol on renal function." Br J Anaesth 68 (1992): 481-5

11. Boras-Uber LA, Brackett NC Jr "Ketorolac-induced acute renal failure." Am J Med 92 (1992): 450-2

12. "Product Information. Toradol (ketorolac)." Syntex Laboratories Inc, Palo Alto, CA.

13. Myles PS, Power I "Does ketorolac cause postoperative renal failure: how do we assess the evidence?" Br J Anaesth 80 (1998): 420-1

14. Feldman HI, Kinman JL, Strom BL "Acute renal failure and ketorolac." Ann Intern Med 127 (1997): 493-4

15. Singh G, Ramey DR, Morfeld D, Fries JF "Comparative toxicity of non-steroidal anti-inflammatory agents." Pharmacol Ther 62 (1994): 175-91

16. Haragsim L, Dalal R, Bagga H, Bastani B "Ketorolac-induced acute renal failure and hyperkalemia: report of three cases." Am J Kidney Dis 24 (1994): 578-80

17. Buck ML, Norwood VF "Ketorolac-induced acute renal failure in a previously healthy adolescent." Pediatrics 98 (1996): 294-6

18. Wolfe PA, Polhamus CD, Kubik C, Robinson AB, Clement DJ "Giant duodenal ulcers associated with the postoperative use of ketorolac: report of three cases." Am J Gastroenterol 89 (1994): 1110-1

19. Wiedrick JE, Friesen EG, Garton AM, Otten NH "Upper gastrointestinal bleeding associated with oral ketorolac therapy." Ann Pharmacother 28 (1994): 1109

20. Buckley MM, Brogden RN "Ketorolac. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential." Drugs 39 (1990): 86-109

21. Fuller DK, Kalekas PJ "Ketorolac and gastrointestinal ulceration." Ann Pharmacother 27 (1993): 978-9

22. Estes LL, Fuhs DW, Heaton AH, Butwinick CS "Gastric ulcer perforation associated with the use of injectable ketorolac." Ann Pharmacother 27 (1993): 42-3

23. Sacanella E, Munoz F, Cardellach F, Estruch R, Miro O, Urbanomarquez A "Massive haemorrhage due to colitis secondary to nonsteroidal anti-inflammatory drugs." Postgrad Med J 72 (1996): 57-8

24. Buchman AL, Schwartz MR "Colonic ulceration associated with the systemic use of nonsteroidal antiinflammatory medication." J Clin Gastroenterol 22 (1996): 224-6

25. Strom BL, Berlin JA, Kinman JL "Parenteral ketorolac and risk of gastrointestinal and operative site bleeding: a postmarketing surveillance study." JAMA 275 (1996): 376-82

26. Quigley EMM, Donovan JP, Livingston WC "Ketorolac-related giant gastric ulcers." Am J Gastroenterol 89 (1994): 631-2

27. Maliekal J, Elboim CM "Gastrointestinal complications associated with intramuscular ketorolac tromethamine therapy in the elderly." Ann Pharmacother 29 (1995): 698-701

28. Concannon MJ, Meng L, Welsh CF, Puckett CL "Inhibition of perioperative platelet aggregation using toradol (ketorolac)." Ann Plast Surg 30 (1993): 264-6

29. Thwaites BK, Nigus DB, Bouska GW, Mongan PD, Ayala EF, Merrill GA "Intravenous ketorolac tromethamine worsens platelet function during knee arthroscopy under spinal anesthesia." Anesth Analg 82 (1996): 1176-81

30. Zikowski D, Hord AH, Haddox JD, Glascock J "Ketorolac-induced bronchospasm." Anesth Analg 76 (1993): 417-9

31. Johnson AG, Nguyen TV, Day RO "Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis." Ann Intern Med 121 (1994): 289-300

32. Gurwitz JH, Avron J, Bohn RL, Glynn RJ, Monane M, Mogun H "Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy." JAMA 272 (1994): 781-6

33. Haddow GR, Riley E, Isaacs R, McSharry R "Ketorolac, nasal polyposis, and bronchial asthma: a cause for concern." Anesth Analg 76 (1993): 420-2

34. Shapiro N "Acute angioedema after ketorolac ingestion - report of case." J Oral Maxillofac Surg 52 (1994): 626-7

35. Seitz B, Sorken K, Labree LD, Garbus JJ, Mcdonnell PJ "Corneal sensitivity and burning sensation: comparing topical ketorolac and diclofenac." Arch Ophthalmol 114 (1996): 921-4

36. Parent M, Patrice M "Weight gain associated with long-term oral ketorolac tromethamnine." Ann Pharmacother 28 (1994): 284-5

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