Black Box Warning

BOXED WARNING — Duration Limitation: Ketorolac is indicated only for short-term (≤5 days) management of moderately severe acute pain. Increasing dose or duration does NOT improve efficacy but greatly increases risk of serious adverse effects.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Ketorolac.

Other warnings & precautions

BOXED WARNING — Gastrointestinal Risk: NSAIDs cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation which can be fatal. Risk increases with duration, dose, history of GI disease, alcohol, smoking, and age ≥65.
BOXED WARNING — Cardiovascular Risk: NSAIDs may increase risk of serious cardiovascular thrombotic events. Contraindicated for treatment of perioperative pain in the setting of CABG surgery.
BOXED WARNING — Renal Risk: NSAIDs may cause acute kidney injury. Contraindicated in patients with advanced renal disease.
BOXED WARNING — Bleeding Risk: Inhibits platelet aggregation and prolongs bleeding time. Contraindicated perioperatively when hemostasis is critical.
Contraindicated in pregnancy (3rd trimester), nursing mothers, prior to or following coronary artery bypass graft surgery.
Elderly patients (≥65) and those with low body weight (<50 kg) are at greater risk of adverse effects — use lower doses.

Black Box Warning

Other warnings & precautions

BOXED WARNING — Gastrointestinal Risk: NSAIDs cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation which can be fatal. Risk increases with duration, dose, history of GI disease, alcohol, smoking, and age ≥65.
BOXED WARNING — Cardiovascular Risk: NSAIDs may increase risk of serious cardiovascular thrombotic events. Contraindicated for treatment of perioperative pain in the setting of CABG surgery.
BOXED WARNING — Renal Risk: NSAIDs may cause acute kidney injury. Contraindicated in patients with advanced renal disease.
BOXED WARNING — Bleeding Risk: Inhibits platelet aggregation and prolongs bleeding time. Contraindicated perioperatively when hemostasis is critical.
Contraindicated in pregnancy (3rd trimester), nursing mothers, prior to or following coronary artery bypass graft surgery.
Elderly patients (≥65) and those with low body weight (<50 kg) are at greater risk of adverse effects — use lower doses.

Ketorolac Black Box Warning

Black Box Warning

Other warnings & precautions

Ketorolac Black Box Warning

Black Box Warning

Other warnings & precautions