"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Sprix Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Sprix (ketorolac tromethamine) is a nonsteroidal anti-inflammatory drug (NSAID) used in adults for short term (up to 5 days) management of moderate to moderately severe pain that requires pain relief at the opioid level. Common side effects include nasal pain or discomfort.
The recommended dose of Sprix is 31.5 mg (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg (four doses). Sprix may interact with aliskiren, ACE Inhibitors, angiotensin II receptor blockers (ARBs), cidofovir, probenecid, corticosteroids, clopidogrel, blood thinners, other forms of ketorolac, high doses of aspirin, or other NSAIDs. Check all prescription and over-the-counter medicine labels since many contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). Tell your doctor all medications and supplements you use. During pregnancy, Sprix should be used only if prescribed during the first 30 weeks. After 30 weeks, use of Sprix is not recommended as it could harm a fetus; consult your doctor. Sprix passes into breast milk. Consult your doctor before breastfeeding.
Our Sprix (ketorolac tromethamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sprix FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed else wherein the labeling:
- Gastrointestinal effects [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Hemorrhage [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Renal effects [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
- Cardiovascular thrombotic events [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Congestive heart failure and edema [see WARNINGS AND PRECAUTIONS]
- Serious skin reactions [see WARNINGS AND PRECAUTIONS]
- Hepatic effects [see WARNINGS AND PRECAUTIONS]
The most frequently reported adverse reactions were related to local symptoms, i.e., nasal discomfort or irritation. These reactions were generally mild and transient in nature.
The most common drug-related adverse events leading to premature discontinuation were nasal discomfort or nasal pain (arthralgia).
Experience From SPRIX Clinical Studies
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to SPRIX inpatients enrolled in placebo-controlled efficacy studies of acute pain following major surgery. The studies enrolled 828 patients (183 men, 645 women) ranging from 18 years to over 75 years of age.
The patients in the postoperative pain studies had undergone major abdominal, orthopedic, gynecologic, or other surgery; 455patients received SPRIX (31.5 mg) three or four times a day for up to 5 days, and 245 patients received placebo. Most patients were receiving concomitant opioids, primarily PCA morphine.
Table 1: Post-operative Patients with AdverseReactions Observed at a rate of 2% or more and at least twice the incidence of the placebo group.
|Throat irritation||4%||< 1%|
|Urine output decreased||2%||< 1%|
|ALT and/or AST increased||2%||1%|
In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, seven patients (N=455, 1.5%) treated with SPRIX experienced serious adverse events of bleeding (4 patients) or hematoma (3 patients) at the operative site versus one patient (N=245, 0.4%) treated with placebo (hematoma). Six of the seven patients treated with SPRIX underwent a surgical procedure and/or blood transfusion and the placebo patient subsequently required a blood transfusion.
Adverse Reactions Reported In ClinicalTrials With Other Dosage Forms Of Ketorolac Or Other NSAIDs
Adverse reaction rates increase with higher doses of ketorolac. It is necessary to remain alert for the severe complications of treatment with ketorolac, such as GI ulceration, bleeding, and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions, and liver failure. These complications can be serious in certain patients for whom ketorolac is indicated, especially when the drug is used inappropriately.
In patients taking ketorolac or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Gastrointestinal (GI)experiences including:
|flatulence||GI fullness||GI ulcers (gastric/duodenal)|
|abnormal renal function||anemia||dizziness|
|drowsiness||edema||elevated liver enzymes|
|headache*||hypertension||increased bleeding time|
|injection site pain||pruritus||purpura|
|*Incidence greater than 10%|
Additional adverse experiences reported occasionally ( < 1% in patients taking ketorolac or other NSAIDs in clinical trials) include:
Body as a Whole: fever, infection, sepsis
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
Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss
Adverse Reactions From PostmarketingExperience With Other Dosage Forms Of Ketorolac Or Other NSAIDs
Other observed reactions (reported from postmarketing experience in patients taking ketorolac or otherNSAIDs) are:
Respiratory: bronchospasm, respiratory depression, pneumonia
Read the entire FDA prescribing information for Sprix (Ketorolac Tromethamine Nasal Spray)
Additional Sprix Information
- Sprix Drug Interactions Center: ketorolac nasl
- Sprix Side Effects Center
- Sprix FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.