Ketorolac

Is ketorolac safe?

For a few days of severe pain, in someone with a healthy stomach and kidneys, it usually is. That is what it is licensed for. The label approves it for pain bad enough to need an opioid, usually after surgery, and it carries no risk of addiction.

The catch is the stomach. In a 2012 analysis of 28 observational studies, ketorolac carried 11.5 times the risk of serious stomach bleeding, perforation or blockage seen in people taking no NSAID. That was the highest of the common NSAIDs, about six times ibuprofen and nearly three times ketoprofen. We score it 61, the lowest of the NSAIDs we rate.

Why the 5-day limit?

The US label is built around one idea: ketorolac is safe enough for a short course and not for anything longer. It sets rules that no other NSAID has.

• Treatment starts with an injection into a vein or muscle. Tablets are only for continuing it, if needed.
• Injections and tablets together must not go past 5 days.
• By mouth, 20 mg first (10 mg for people 65 or over, under 50 kg, or with kidney problems), then 10 mg every 4 to 6 hours, at most 40 mg a day.
• It is not for children, and not for minor or long-lasting pain.

Going above 40 mg a day does not improve pain relief, the label says, but it does raise the risk of serious harm. The UK is stricter on injections. The product information for Toradol injection (revised 2024) caps a course at 2 days and 90 mg a day, or 60 mg for people who are older, under 50 kg or have kidney problems. In 2007 the MHRA also said ketorolac should be started only in hospital, with tablets for no more than 7 days.

How hard is it on the stomach?

Harder than any other NSAID on the US market, on the available data. The SOS project pooled observational studies of serious upper stomach complications:

The range around the ketorolac figure is wide (5.6 to 23.8 times) because fewer studies measured it. Still, every estimate points the same way.

Short courses do not make the risk go away. The label reports a post-marketing study of about 10,000 hospital patients given ketorolac injections for up to 5 days. Clinically serious stomach bleeding hit 0.4% of patients under 65 with no ulcer history on 60 mg a day or less. Above 120 mg a day it was 4.6%. For people over 65 who had had an ulcer or bleed before, it ran from 2.8% to 25% depending on dose. Age, dose and a past ulcer all push the risk up, and the label says it also grows with each day of use.

Kidneys, bleeding and surgery

Ketorolac blocks the platelets that help blood clot, so the label rules it out before major surgery, in anyone with bleeding in the brain or a bleeding disorder, and during labour and delivery. Wound bleeding has been reported when it is given around the time of an operation.

The kidneys are the other weak point. Ketorolac is cleared mainly by the kidneys, and the label forbids it in advanced kidney disease and in people at risk of kidney failure from dehydration or blood loss. The 2023 Beers Criteria, the main US list of medicines older adults should avoid, name ketorolac (by mouth or injection) for bleeding and acute kidney injury.

Like every NSAID, it also carries the boxed warningBoxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary for heart attack and stroke.

Who should not take ketorolac

The label rules it out if you:

• have a stomach ulcer now or have ever had one, or have ever had a stomach bleed or perforation
• have had asthma, hives or swelling after aspirin or another NSAID
• have advanced kidney disease, or are dehydrated
• take aspirin or any other NSAID, probenecid or pentoxifylline
• have a bleeding disorder or a high bleeding risk
• are in labour, or have just had heart bypass surgery

Talk to your doctor first if you take a blood thinner, an SSRI, a steroid, lithium or methotrexate, or if you are pregnant. NSAIDs should be limited from 20 weeks of pregnancy. In an overdose, call Poison Control on 1-800-222-1222 in the US or NHS 111 in the UK. A low score is no reason to refuse a dose your doctor or the hospital has chosen for you; ask how many days you will take it and what comes next.

How we scored it

Dependence (97) is excellent and track record (88) solid. Serious side effects (40) and regulatory warnings (25) are the lowest of the NSAIDs we score: the stomach risk in real-world studies is about three times that of most others, and the label carries a 5-day limit and a long list of patients who must not take it. Compared with meloxicam (73), ketorolac trades safety for strength and is meant for days, not months.