Generic name
Ketorolac tromethamine: adverse event reports filed with FDA
2,218 reports list it as a suspect or interacting product, 2004–2026. Also reported as Ketorolac Tromethamine Injection Usp, Ketorolac Tromethamine Injection.
- 2,218
- reports as suspect product
- 0% of all reports · about 99 a year
- 103
- reports, 12 months to June 2026
- 121 in the 12 months before
- 49.4%
- marked serious by the reporter
- 57.4% across all reports
- 4.7%
- record death among outcomes, as reported
- 104 reports · not verified by FDA
Between January 2004 and June 2026, 2,218 adverse event reports received by FDA list ketorolac tromethamine, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (2,139) are left out of every figure here.
In the 12 months to June 2026, 103 reports listed it, down 15% from 121 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 99 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (17.2%), drug hypersensitivity (11.8%) and treatment failure (9%). A report can list several reactions, so shares add to more than 100%; 464 different terms appear across these reports. Drug ineffective is recorded in 17.2% of these reports, against 6.3% of all reports in the database.
49.4% of the reports are marked serious by the reporter; 4.7% record death among the outcomes and 23.5% record hospitalisation, as reported. 36.4% of the reports came from consumers, and the largest patient age group is 45 to 64 (20.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Ketorolac tromethamine reports recording the termall reports in the database
- Drug ineffectivethe medicine did not work as expected17.2%382
- Drug hypersensitivityan allergic-type reaction to a medicine11.8%261
- Treatment failurethe treatment did not work9%200
- Dyspnoeashortness of breath4.4%97
- Nauseafeeling sick3.8%84
- Eye irritationeye irritation3.6%79
- Off label useused for a purpose or in a way not on the label2.8%61
- Acute kidney injurysudden loss of kidney function2.7%59
- Anaphylactic reactiona severe, sudden allergic reaction2.6%57
- Rashskin rash2.6%57
- Product dose omission issuea dose was missed2.3%52
- Urticariahives2.2%48
- Vomitingbeing sick2.1%47
- Asthmaasthma2.1%46
- Painpain, site not specified2%45
- Fatiguetiredness2%44
- Product quality issuea problem with the product itself1.9%43
- Dizzinesslight-headedness or unsteadiness1.9%42
- Eye paineye pain1.9%42
- Headachehead pain1.9%42
- Renal failure acute1.8%40
- Drug intolerancethe medicine was not tolerated1.7%38
- Angioedemadeep swelling of skin or mucous membranes1.6%36
- Drug abusemisuse of a medicine1.6%36
- Chest painchest pain1.6%35
- Product use issuea problem in how the product was used1.6%35
- Pruritusitching1.6%35
- Vision blurredblurred vision1.6%35
- Bronchitischest infection1.5%33
- Product use in unapproved indicationused for a purpose not on the label1.5%33
Top 30 of 464 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 73.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Cataract operation | 195 | 8.8% |
| Pain | 187 | 8.4% |
| Back pain | 41 | 1.8% |
| Analgesic therapy | 39 | 1.8% |
| Migraine | 30 | 1.4% |
| Procedural pain | 23 | 1% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,218 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Ketorolac tromethamine reports |
|---|---|---|
| Acetaminophen | 173 | 7.8% |
| Ibuprofen | 115 | 5.2% |
| Aspirin | 97 | 4.4% |
| Zaditor | 94 | 4.2% |
| Gabapentin | 81 | 3.7% |
| Azelastine hydrochloride | 69 | 3.1% |
| Prednisone | 65 | 2.9% |
| Fentanyl | 64 | 2.9% |
| Propofol | 61 | 2.8% |
| Pataday | 55 | 2.5% |
Other products listed in reports where Ketorolac tromethamine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Ketorolac tromethamine | All reports |
|---|---|---|
| Reports as suspect product | 2,218 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 103 | 1,332,454 |
| Marked serious | 49.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 47 | 91 |
| Hospitalisation recorded, per 1,000 reports | 235 | 213 |
| Consumer-filed share | 36.4% | 45.8% |
| Top term, share of reports | Drug ineffective 17.2% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Ketorolac tromethamine reports
How many adverse event reports has FDA received for Ketorolac tromethamine?
2,218 reports list Ketorolac tromethamine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 103 of them arrived in the latest 12 months. Another 2,139 list it only as a concomitant medication.
What reactions are recorded in Ketorolac tromethamine reports?
drug ineffective (17.2%), drug hypersensitivity (11.8%), treatment failure (9%), dyspnoea (4.4%) and nausea (3.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Ketorolac tromethamine was responsible.
How serious are the reports?
49.4% are marked serious by the reporter. Among the outcomes recorded, 4.7% of reports include death and 23.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (36.4%), other health professional (29.1%) and physician (18.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ketorolac tromethamine rising?
103 reports in the 12 months to June 2026, down 15% from 121 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Ketorolac tromethamine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Ketorolac tromethamine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ketorolac tromethamine as a suspect or interacting product; reports listing it only as a concomitant medication (2,139) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.