Sprix Side Effects

Generic name: ketorolac

Medically reviewed by Drugs.com. Last updated on Jun 13, 2024.

Note: This document provides detailed information about Sprix Side Effects associated with ketorolac. Some dosage forms listed on this page may not apply specifically to the brand name Sprix.

Applies to ketorolac: nasal spray.

Other dosage forms:

• solution, tablet

Serious side effects of Sprix

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:

Other side effects of Sprix

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:

Precautions

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Do not use any other form of ketorolac (eg, injection or tablets) or other NSAIDs, unless your doctor says it is okay. Some examples of NSAIDs are aspirin, diclofenac, ibuprofen, or naproxen (Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®). Also, you should not use this medicine together with pentoxifylline (Trental®) or probenecid (Benemid®).

Ketorolac may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). Call your doctor right away if you have bloody or black, tarry stools, severe stomach pain or heartburn, or vomiting of blood or material that looks like coffee grounds.

Ketorolac may increase your risk of having blood clots, heart attack, or stroke. This is more likely in people who already have heart disease. Call your doctor right away if you have chest pain or discomfort, an irregular or fast heartbeat, severe indigestion or heartburn, nausea, sweating, or troubled breathing with exertion.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. Do not use this medicine during the latter part of a pregnancy unless your doctor tells you to.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

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

General adverse events

The most common adverse reactions among patients treated with ketorolac (the active ingredient contained in Sprix) include abdominal pain, nausea, dyspepsia, and headaches. For patients receiving the nasal spray, nasal discomfort, rhinalgia, increased lacrimation, throat irritation, and rhinitis were reported.^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain, dyspepsia, nausea
• Common (1% to 10%): Constipation, diarrhea, flatulence, gastrointestinal (GI) fullness, GI ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, stomatitis, vomiting, throat irritation (nasal spray)
• Frequency not reported: Anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, melena, rectal bleeding, increased appetite, peptic ulcers, ulcers, hematemesis, gastritis
• Postmarketing reports: Acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease), eructation^[Ref]

A large postmarketing observational study (n=10,000) revealed the incidence of clinically serious gastrointestinal (GI) bleeding was dose dependent and more than double in patients 65 years or older. The incidence of clinically serious GI bleeding after up to 5 days of treatment with doses of 60 mg or less, greater than 60 to 90 mg, greater than 90 to 120 mg, or greater than 120 mg, respectively was 0.4%, 0.4%, 0.9%, and 4.6% in those less than 65 years compared with 1.2%, 2.8%, 2.2%, and 7.7% in those 65 years or older. Among patients with a history of GI perforation, ulcer, or bleeding, these numbers were 2.1%, 4.6%, 7.8%, and 15.4% compared with 4.7%, 3.7%, 2.8%, and 25%, in younger and older patients, respectively.^[Ref]

Hematologic

• Common (1% to 10%): Anemia, increased bleeding time
• Frequency not reported: Bleeding, hematoma, postoperative wound hemorrhage
• Postmarketing reports: Agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, thrombocytopenia purpura, thrombocytopenia, neutropenia, postoperative wound hemorrhage (rarely requiring blood transfusion)^[Ref]

Serious events of bleeding (n=4) or hematoma (n=3) at the operative site were reported in controlled clinical trials in patients (n=455) undergoing major surgeries (primarily knee and hip replacements, and abdominal hysterectomies) receiving ketorolac nasal spray compared with 1 patient in the placebo group (hematoma).

In pediatric patients, an increased risk of bleeding was observed following tonsillectomy. In a retrospective analysis, risk of bleeding following a tonsillectomy with or without adenoidectomy was 10.1% in patients receiving this drug compared with 2.2% in those receiving opioids. The postoperative hemorrhage rate in patients 12 years and younger was 6.5% with ketorolac treatment versus 3.3% without. In a prospective study in patients 3 to 9 years undergoing tonsillectomy with or without adenoidectomy, the overall incidence of bleeding in patients receiving this drug was 16.3% compared with 17% in children receiving morphine. However, during the first 24 hours after surgery, bleeding was observed in 14.3% of the ketorolac group versus 4.2% of the morphine group.^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, hypertension, bradycardia
• Frequency not reported: Congestive heart failure, palpitations, pallor, tachycardia, syncope, cardiac failure
• Postmarketing reports: Arrhythmia, chest pain, flushing, hypotension, myocardial infarction, vasculitis^[Ref]

Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.^[Ref]

Dermatologic

• Common (1% to 10%): Rash, pruritus, purpura, sweating

Very rare (less than 0.01%):

• Frequency not reported: Alopecia, photosensitivity, urticaria
• Postmarketing reports: Angioedema, exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis^[Ref]

Hypersensitivity

• Frequency not reported: Anaphylactoid reactions
• Postmarketing reports: Laryngeal edema, tongue edema^[Ref]

Renal

• Common (1% to 10%): Abnormal renal function, oliguria
• Postmarketing reports: Acute renal failure, nephrotic syndrome^[Ref]

Hepatic

• Common (1% to 10%): Elevated liver enzymes
• Frequency not reported: Hepatitis, jaundice, liver failure^[Ref]

Metabolic

• Frequency not reported: Weight change
• Postmarketing reports: Hyperglycemia, hyperkalemia, hyponatremia^[Ref]

Respiratory

• Very common (10% or more): Nasal discomfort (15%, nasal spray), rhinalgia (13%, nasal spray)
• Common (1% to 10%): Rhinitis (nasal spray)
• Frequency not reported: Epistaxis, pulmonary edema, asthma
• Postmarketing reports: Bronchospasm, respiratory depression, pneumonia^[Ref]

Nervous system

• Very common (10% or more): Headaches
• Common (1% to 10%): Drowsiness, dizziness
• Frequency not reported: Extrapyramidal symptoms, hyperkinesis, inability to concentrate, insomnia, paresthesia, somnolence, stupor, tremors
• Postmarketing reports: Aseptic meningitis, convulsions, coma, taste abnormality^[Ref]

Local

• Common (1% to 10%): Injection site pain^[Ref]

Ocular

• Common (1% to 10%): Lacrimation increased (nasal spray)
• Postmarketing reports: Conjunctivitis, optic neuritis, visual disturbances, abnormal vision^[Ref]

Psychiatric

• Frequency not reported: Anxiety, depression, euphoria, hallucinations, abnormal dreams, abnormal thinking
• Postmarketing reports: Psychosis^[Ref]

Other

• Common (1% to 10%): Tinnitus
• Frequency not reported: Fever, asthenia, malaise, vertigo, hearing loss^[Ref]

Endocrine

• Frequency not reported: Female infertility^[Ref]

Genitourinary

• Postmarketing reports: Flank pain with or without hematuria and/or azotemia, hemolytic uremia syndrome, increased urinary frequency, oliguria, interstitial nephritis, urinary retention^[Ref]

Immunologic

• Frequency not reported: Infections, sepsis^[Ref]

Musculoskeletal

• Postmarketing reports: Myalgia^[Ref]

See also:

Frequently asked questions

• How and where is the Toradol injection given?
• Which painkiller should you use?
• How long does ketorolac (Toradol) stay in your system?

Further information

Sprix side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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