Ketorolac Tromethamine side effects: what 5,594 FDA adverse event reports show
Drug class
Not stated in label
Who reports
5,594 reports · 56% serious · 306 with death outcome · 65% female
Used for
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
What it is
DESCRIPTION Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs).
Boxed warning
Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 397 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eye inflammation | 40 | 15.9 11.7–21.7ROR 16.1 · χ² 544 / p 2e-120 | 15.7 EB05 11.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Eye pain | 208 | 14.2 12.4–16.2ROR 14.7 · χ² 2,528 / p <1e-300 | 14.1 EB05 12.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.7 | no trial data cached |
| Eye irritation | 176 | 11.9 10.3–13.7ROR 12.2 · χ² 1,739 / p <1e-300 | 11.8 EB05 10.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 39 | 11.4 8.3–15.6ROR 11.5 · χ² 359 / p 2e-80 | 11.0 EB05 8.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 | no trial data cached |
| Obstructive airways disorder | 32 | 10.8 7.6–15.2ROR 10.8 · χ² 273 / p 1e-61 | 10.2 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 14% (drug 65%) | no trial data cached |
| Treatment failure | 213 | 9.7 8.5–11.1ROR 10.1 · χ² 1,665 / p <1e-300 | 9.6 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Respiratory depression | 31 | 9.5 6.7–13.5ROR 9.5 · χ² 227 / p 2e-51 | 8.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · ♀ 26% (drug 65%) | no trial data cached |
| Cardiomyopathy | 36 | 9.1 6.6–12.7ROR 9.2 · χ² 252 / p 4e-57 | 8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 24% (drug 65%) | no trial data cached |
| Ocular discomfort | 25 | 8.6 5.8–12.8ROR 8.7 · χ² 161 / p 3e-37 | 7.8 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=6 · 72% consumer | no trial data cached |
| Tenderness | 24 | 8.6 5.8–12.9ROR 8.7 · χ² 154 / p 1e-35 | 7.7 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Infusion site pain | 29 | 8.5 5.9–12.3ROR 8.6 · χ² 185 / p 2e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=15 · ♀ 93% (drug 65%) · 76% consumer | no trial data cached |
| Sneezing | 50 | 8.4 6.4–11.1ROR 8.5 · χ² 318 / p 2e-71 | 8.0 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 86% consumer | no trial data cached |
| Cataract | 115 | 7.3 6.1–8.7ROR 7.4 · χ² 617 / p 2e-136 | 7.1 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Visual acuity reduced | 64 | 7.2 5.6–9.2ROR 7.2 · χ² 334 / p 8e-75 | 6.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Photophobia (light sensitivity) | 35 | 7.0 5.1–9.8ROR 7.1 · χ² 175 / p 3e-40 | 6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Lacrimation increased | 54 | 6.8 5.2–8.8ROR 6.8 · χ² 260 / p 7e-59 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Economic problem | 27 | 6.6 4.5–9.6ROR 6.6 · χ² 122 / p 1e-28 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 | no trial data cached |
| Eosinophilia | 30 | 6.4 4.5–9.2ROR 6.5 · χ² 132 / p 6e-31 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · ♀ 14% (drug 65%) | no trial data cached |
| Drug hypersensitivity | 329 | 6.4 5.7–7.1ROR 6.7 · χ² 1,491 / p <1e-300 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Flank pain | 15 | 6.0 3.6–10.0ROR 6.0 · χ² 58 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Ocular hyperaemia | 74 | 5.9 4.7–7.5ROR 6.0 · χ² 299 / p 2e-67 | 5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Sars-cov-2 test positive | 21 | 5.9 3.8–9.0ROR 5.9 · χ² 81 / p 1e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Seasonal allergy | 22 | 5.8 3.9–8.9ROR 5.9 · χ² 84 / p 3e-20 | 5.2 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=17 · ♀ 100% (drug 65%) · 77% consumer | no trial data cached |
| Spinal pain | 18 | 5.8 3.6–9.1ROR 5.8 · χ² 66 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Renal tubular necrosis | 15 | 5.7 3.5–9.5ROR 5.7 · χ² 54 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Gallbladder disorder | 27 | 5.7 3.9–8.2ROR 5.7 · χ² 99 / p 1e-23 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Post procedural complication | 28 | 5.5 3.8–7.9ROR 5.5 · χ² 97 / p 3e-23 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · ♀ 43% (drug 65%) | no trial data cached |
| Vitreous floaters | 14 | 5.4 3.2–9.1ROR 5.4 · χ² 46 / p 7e-12 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Eye disorder | 47 | 5.4 4.0–7.2ROR 5.4 · χ² 163 / p 1e-37 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Poor venous access | 14 | 5.1 3.0–8.6ROR 5.1 · χ² 42 / p 5e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Atelectasis | 13 | 5.0 2.9–8.7ROR 5.0 · χ² 38 / p 4e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Osteomyelitis | 24 | 5.0 3.3–7.4ROR 5.0 · χ² 72 / p 9e-18 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Renal failure acute | 57 | 5.0 3.8–6.4ROR 5.0 · χ² 177 / p 1e-40 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · ♀ 40% (drug 65%) · 92% clinician | no trial data cached |
| Eye swelling | 48 | 4.9 3.7–6.5ROR 4.9 · χ² 144 / p 2e-33 | 4.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Intervertebral disc degeneration | 12 | 4.8 2.7–8.5ROR 4.8 · χ² 33 / p 5e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Migraine | 121 | 4.8 4.0–5.7ROR 4.9 · χ² 359 / p 2e-80 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 92% (drug 65%) | no trial data cached |
| Eye discharge | 13 | 4.8 2.8–8.2ROR 4.8 · χ² 35 / p 2e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Sinus tachycardia | 18 | 4.8 3.0–7.6ROR 4.8 · χ² 50 / p 9e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 69 | 4.7 3.7–6.0ROR 4.8 · χ² 198 / p 3e-45 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.5 | no trial data cached |
| Hiatus hernia | 16 | 4.6 2.8–7.5ROR 4.6 · χ² 42 / p 5e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 572 | 1.6 1.5–1.8ROR 1.7 · χ² 147 / p 4e-34 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Drug hypersensitivity | 329 | 6.4 5.7–7.1ROR 6.7 · χ² 1,491 / p <1e-300 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Headache | 283 | 1.7 1.5–1.9ROR 1.7 · χ² 82 / p 6e-20 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Pain | 279 | 1.7 1.5–1.9ROR 1.7 · χ² 82 / p 7e-20 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled — boxed warning exact term | serious PRR 2.1 | no trial data cached |
| Treatment failure | 213 | 9.7 8.5–11.1ROR 10.1 · χ² 1,665 / p <1e-300 | 9.6 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Eye pain | 208 | 14.2 12.4–16.2ROR 14.7 · χ² 2,528 / p <1e-300 | 14.1 EB05 12.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.7 | no trial data cached |
| Eye irritation | 176 | 11.9 10.3–13.7ROR 12.2 · χ² 1,739 / p <1e-300 | 11.8 EB05 10.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Product dose omission issue | 145 | 1.9 1.6–2.2ROR 1.9 · χ² 63 / p 1e-15 | 1.9 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.6 · 75% consumer | no trial data cached |
| Vision blurred (blurred vision) | 145 | 4.0 3.4–4.7ROR 4.1 · χ² 322 / p 2e-72 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Anxiety | 138 | 1.8 1.5–2.1ROR 1.8 · χ² 50 / p 7e-13 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Back pain | 135 | 2.2 1.8–2.6ROR 2.2 · χ² 86 / p 1e-20 | 2.2 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Chest pain | 130 | 2.6 2.2–3.1ROR 2.7 · χ² 130 / p 2e-30 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Migraine | 121 | 4.8 4.0–5.7ROR 4.9 · χ² 359 / p 2e-80 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 92% (drug 65%) | no trial data cached |
| Cataract | 115 | 7.3 6.1–8.7ROR 7.4 · χ² 617 / p 2e-136 | 7.1 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Sinusitis | 98 | 3.6 2.9–4.4ROR 3.6 · χ² 180 / p 3e-41 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 87% (drug 65%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Eye inflammation — n=40, PRR 15.9
- Eye irritation — n=176, PRR 11.9
- Obstructive airways disorder — n=32, PRR 10.8
- Cardiomyopathy — n=36, PRR 9.1
- Ocular discomfort — n=25, PRR 8.6
- Tenderness — n=24, PRR 8.6
- Sneezing — n=50, PRR 8.4
- Cataract — n=115, PRR 7.3
- Visual acuity reduced — n=64, PRR 7.2
- Photophobia — n=35, PRR 7.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ketorolac Tromethamine?
In FDA FAERS, the most frequently co-reported reaction terms for Ketorolac Tromethamine are drug hypersensitivity, headache, pain, eye pain, eye irritation, vision blurred. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ketorolac Tromethamine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary.
Do FAERS signals prove that Ketorolac Tromethamine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 014ba8d7-7ed3-4d4a-847a-22b65161117e, effective 20210701; matched on
openfda.generic_name.exact:"KETOROLAC TROMETHAMINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 437 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.