What the label lists and what reports show
Ketorolac side effects
Ketorolac's FDA label: “In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: * Incidence greater than 10% Gastrointestinal (GI) experiences including: abdominal pain …” FAERS holds 5,597 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (329 reports).
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the ketorolac FDA label on DailyMed (effective August 31, 2023, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NSAIDs?NSAIDs can cause serious side effects, including: See “ What is the most important information I should know about medicines called NonSteroidal Anti-inflammatory Drugs (NSAIDs)? ” new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. […]
Source: FDA drug label, Fresenius Kabi USA, LLC, effective August 31, 2023 (SPL set 3d88cbe6-5230-47aa-80af-0c41283d1f00), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: * Incidence greater than 10% Gastrointestinal (GI) experiences including: abdominal pain constipation/diarrhea dyspepsia flatulence GI fullness GI ulcers (gastric/duodenal) […]
Table 3: Incidence of Clinically Serious G.I. Bleeding as Related to Age, Total Daily Dose, and History of G.I. Perforation, Ulcer, Bleeding (PUB) after up to 5 Days of Treatment with Ketorolac Tromethamine Injection
| Reaction | ≤60 mg | >60 to 90 mg | >90 to 120 mg | >120 mg |
|---|---|---|---|---|
| <65 years of age | 0.4% | 0.4% | 0.9% | 4.6% |
| ≥65 years of age | 1.2% | 2.8% | 2.2% | 7.7% |
| <65 years of age | 2.1% | 4.6% | 7.8% | 15.4% |
| ≥65 years of age | 4.7% | 3.7% | 2.8% | 25.0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedAdverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.
Source: FDA drug label, Fresenius Kabi USA, LLC, effective August 31, 2023 (SPL set 3d88cbe6-5230-47aa-80af-0c41283d1f00), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,597 reports list ketorolac among the medicines taken, each a report of something that happened, not proof the medicine caused it; 306 are coded as a death and 1,451 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ketorolac: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions