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Ketorolac Side Effects

The most commonly reported side effects of ketorolac include nausea, off label use, and pain, based on 20,725 FDA adverse event reports from 2004 to 2025. 9.6% of reports found the drug to be ineffective.

Ketorolac side effects

Percentages show how often each reaction appears relative to total reports for ketorolac.

1
Drug Ineffective9.6%1,987
2
Nausea6.4%1,327
3
Off Label Use6.1%1,272
4
Pain5.5%1,147
5
Drug Hypersensitivity5.1%1,066
6
Headache4.4%918
7
Chronic Kidney Disease4.2%869
8
Fatigue4.1%849
9
Acute Kidney Injury4.1%846
10
Treatment Failure3.8%794
11
Dyspnoea3.7%769
12
Diarrhoea3.1%639
13
Vomiting3.0%620
14
Anxiety2.9%604
15
Arthralgia2.7%565

These are voluntary reports and do not establish that ketorolac caused these reactions.

Report severity

69.1%Serious14,328 reports
32.8%Hospitalizations6,799 reports
6.0%Fatal1,244 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ketorolac drug interactions

Other drugs that appear in adverse event reports alongside ketorolac. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Acetaminophen6.3%1,305
2
Esomeprazole5.3%1,095
3
Omeprazole4.9%1,017
4
Ibuprofen4.6%946
5
Hydromorphone-hydrochloride4.4%907
6
Diclofenac4.2%862
7
Gabapentin3.9%799
8
Pantoprazole-sodium3.8%794
9
Celecoxib3.6%754
10
Ondansetron3.5%727
11
Ethinyl-estradiol3.2%663
12
Drospirenone3.1%643
13
Sodium-oxybate3.1%638
14
Oxycodone2.9%606
15
Fentanyl2.8%577

Taken alongside

1
Acetaminophen24.4%5,058
2
Ondansetron13.1%2,721
3
Ibuprofen11.3%2,347
4
Aspirin10.8%2,248
5
Gabapentin10.4%2,160
6
Albuterol10.1%2,090
7
Ergocalciferol10.1%2,088
8
Prednisone9.4%1,957
9
Oxycodone8.9%1,850
10
Tramadol-hydrochloride8.9%1,848
11
Omeprazole8.9%1,842
12
Hydrocodone8.1%1,689
13
Levothyroxine-sodium7.9%1,647
14
Furosemide7.7%1,592
15
Diphenhydramine7.5%1,557

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ketorolac side effects

59.8% of ketorolac adverse event reports involve female patients and 28.7% involve male patients. The largest age group is adult at 68%. These figures reflect who reports side effects, not underlying risk.

Sex

Female59.8%
Male28.7%
Unknown11.5%

Age group

< 20.6%
2–112.3%
12–172.4%
18–6467.6%
65+27.1%

What is ketorolac used for

Conditions and purposes for which patients were taking ketorolac when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbortionAbscessAbscess DrainageAccident At WorkAcute AbdomenAcute Coronary SyndromeAcute Kidney InjuryAcute Myocardial InfarctionAddison^s DiseaseAdenotonsillectomyAdnexa Uteri Pain

Showing 15 of 787 indications

Ketorolac brand names and reporting trend

Ketorolac is sold under the brand name Sprix.

Brand names

Sprix14,859

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ketorolac with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.