{ "query": "ketorolac", "ingredient": "ketorolac", "slug": "ketorolac", "rxcui": "35827", "brands": [ "Sprix", "Acular", "Acuvail" ], "names": [ "ketorolac", "ketorolac tromethamine" ], "classes": [ { "id": "M01AB", "name": "Acetic acid derivatives and related substances" }, { "id": "S01BC", "name": "Antiinflammatory agents, non-steroids" } ], "alternatives": [ "aceclofenac", "acemetacin", "bromfenac", "bufexamac", "bumadizone", "diclofenac", "etodolac", "flurbiprofen", "indomethacin", "lonazolac", "nepafenac", "oxyphenbutazone", "piroxicam", "proglumetacin", "salicylic acid", "sulindac", "tolmetin", "zomepirac" ], "label": { "route_mode": "ORAL", "route_counts": { "INTRAMUSCULAR": 60, "ORAL": 51, "INTRAVENOUS": 44, "OPHTHALMIC": 28, "INTRAOCULAR": 2, "NASAL": 1 }, "boxed_warning": "WARNING Ketorolac tromethamine tablets, a nonsteroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days. Ketorolac tromethamine tablets are not indicated for use in pediatric patients and they are NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. GASTROINTESTINAL RISK Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with rec...", "indications_and_usage": "INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets USP are indicated for the short-term (\u2264 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and Ketorolac Tromethamine Tablets USP are to be used only as continuation treatment, if necessary. The total combined duration of use of Ketorolac Tromethamine Tablets USP and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS , PRECAUTIONS , DOSAGE AND ADMINISTRATION , and ADVERSE REACTIONS ). Patients should be switched to alternative analgesics as soon as possible, but Ketorolac Tromethamine Tablet USP therapy is not to exceed 5 ...", "contraindications": "CONTRAINDICATIONS (See also Boxed WARNING.) Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. Ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS , Anaphylactoid Reactions and PRECAUTIONS , Preexisting Asthma ). Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion). Ketorolac tromethamine is contraindicat...", "warnings_and_cautions": "", "warnings": "WARNINGS (See also Boxed WARNING .) The total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine are: Gastrointestinal Effects \u2013 Risk of Ulceration, Bleeding, and Perforation Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding. Ketorolac tromethamine can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with ketorolac tromethamine. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatme...", "adverse_reactions": "ADVERSE REACTIONS Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Gastrointestinal (GI) experiences including: abdominal pain * constipation/diarrhea dyspepsia * flatulence GI fullness GI ulcers (gastric/duodenal) gross bleeding/perforation heartburn nausea * stomatitis vomiting Other experiences: abnormal renal function anemia dizziness drowsiness edema elevated liver enzymes headaches * hypertension increased bleeding time injection site pain pruritus purpura rashes tinnitus sweating * Incidence...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Ketorolac tromethamine is a potent NSAID and may cause serious side effects such as gastrointestinal bleeding or kidney failure, which may result in hospitalization and even fatal outcome. Physicians, when prescribing ketorolac tromethamine, should inform their patients or their guardians of the potential risks of ketorolac tromethamine treatment (see Boxed WARNING , WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS sections), instruct patients to seek medical advice if they develop treatment-related adverse events, and advise patients not to give ketorolac tromethamine tablets to other family members and to discard any unused drug. Remember that the total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Cardiovascular Thrombotic...", "spl_medguide": "Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a \u201ccoronary artery bypass graft (CABG).\u201d Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called \u201ccorticosteroids\u201d, \u201canticoagulants\u201d, \u201cSSRIs\u201d, or \u201cSNRIs\u201d increasing doses of NSAIDs older age lo...", "clinical_studies": "CLINICAL STUDIES Adult Patients In a postoperative study, where all patients received morphine by a PCA device, patients treated with ketorolac tromethamine IV as fixed intermittent boluses (e.g., 30 mg initial dose followed by 15 mg q3h), required significantly less morphine (26%) than the placebo group. Analgesia was significantly superior, at various postdosing pain assessment times, in the patients receiving ketorolac tromethamine IV plus PCA morphine as compared to patients receiving PCA-administered morphine alone. Pediatric Patients There are no data available to support the use of ketorolac tromethamine tablets in pediatric patients.", "brand_name": "Ketorolac Tromethamine", "manufacturer": "NuCare Pharmaceuticals, Inc.", "application_number": "ANDA074754", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20240814", "set_id": "415a5393-296f-30e3-e054-00144ff8d46c", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 14911, "serious": 9687, "death": 743, "hospitalization": 4211, "primary_suspect": 14851, "top_reactions": [ [ "Drug Ineffective", 1906 ], [ "Off Label Use", 1271 ], [ "Nausea", 1221 ], [ "Drug Hypersensitivity", 986 ], [ "Pain", 869 ], [ "Headache", 801 ], [ "Treatment Failure", 791 ], [ "Acute Kidney Injury", 755 ], [ "Chronic Kidney Disease", 755 ], [ "Fatigue", 696 ], [ "Dyspnoea", 613 ], [ "Product Use In Unapproved Indication", 576 ], [ "Hyperhidrosis", 568 ], [ "Diarrhoea", 559 ], [ "Vomiting", 536 ] ], "by_year": { "2019": 1663, "2020": 2470, "2021": 1554, "2022": 1350, "2023": 1255, "2024": 1210, "2025": 1366, "2026": 584 }, "by_year_primary": { "2019": 1663, "2020": 2470, "2021": 1550, "2022": 1340, "2023": 1247, "2024": 1203, "2025": 1343, "2026": 579 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20251001", "reason": "Presence of Particulate Matter: Particulate matter identified as glass", "firm": "Aspiro Pharma Limited", "status": "Ongoing" }, { "class": "Class II", "date": "20250905", "reason": "Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns", "firm": "Apotex Corp.", "status": "Ongoing" }, { "class": "Class II", "date": "20250528", "reason": "Lack of Assurance of Sterility", "firm": "Apotex Corp.", "status": "Ongoing" }, { "class": "Class II", "date": "20220810", "reason": "cGMP Deviations: deviations leading to potential cross-contamination.", "firm": "Nephron Sc Inc", "status": "Terminated" }, { "class": "Class I", "date": "20201223", "reason": "Presence of Particulate Matter - found in reserve sample vials at the firm.", "firm": "Fresenius Kabi USA, LLC", "status": "Terminated" }, { "class": "Class II", "date": "20201217", "reason": "Presence of Particulate Matter - found in reserve sample vials at the firm.", "firm": "Fresenius Kabi USA, LLC", "status": "Terminated" }, { "class": "Class I", "date": "20200420", "reason": "Presence of Particulate Matter - found in reserve sample vials at the firm.", "firm": "Fresenius Kabi USA, LLC", "status": "Terminated" }, { "class": "Class II", "date": "20200420", "reason": "Presence of Particulate Matter - found in reserve sample vials at the firm.", "firm": "Fresenius Kabi USA, LLC", "status": "Terminated" }, { "class": "Class II", "date": "20191217", "reason": "Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)", "firm": "Hikma Pharmaceuticals USA Inc.", "status": "Terminated" }, { "class": "Class I", "date": "20191217", "reason": "Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)", "firm": "Hikma Pharmaceuticals USA Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20190430", "reason": "Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.", "firm": "Sagent Pharmaceuticals Inc", "status": "Terminated" }, { "class": "Class II", "date": "20150630", "reason": "Crystallization; identified as calcium salt of Ketorolac", "firm": "Hospira Inc.", "status": "Ongoing" } ], "recall_total": 18, "drugsfda": { "applications": 64, "nda": 7, "anda": 57, "first_approval": "19891130", "rems": false, "rems_last": "", "labeling_supplements": 34, "labeling_recent": 5, "sponsors": [ "ABBVIE", "ADAPTIS", "ALEMBIC", "ALLERGAN", "AMPHASTAR PHARM", "APOTEX", "APOTEX INC", "APOTHECON" ], "unapproved": false, "first_approval_fmt": "11/30/1989" }, "trials": { "total": 689, "completed": 394, "terminated": 102, "with_results": 163, "industry": 101, "phase3": 103, "results_share": 0.4137055837563452, "terminated_share": 0.14804063860667635 }, "pubmed": { "rct": 642, "meta": 39, "recent_rct": 75, "cochrane": [ { "pmid": "33998669", "title": "Single-dose intravenous ketorolac for acute postoperative pain in adults", "year": "2021" }, { "pmid": "29981164", "title": "Ketorolac for postoperative pain in children", "year": "2018" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "ketorolac", "Sprix", "Acular", "Acuvail" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1683907, "beneficiaries": 1031058, "spend": 37161706.690000005, "by_brand": [ { "brand": "Ketorolac Tromethamine", "claims": 1682941, "per_claim": 20.880196127, "is_generic": true }, { "brand": "Sprix", "claims": 735, "per_claim": 2661.6113469, "is_generic": false }, { "brand": "Acular", "claims": 157, "per_claim": 281.10942675, "is_generic": false }, { "brand": "Acular Ls", "claims": 74, "per_claim": 285.81108108, "is_generic": false } ], "per_claim": 22.068740548023143 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 3125, "fills": 1683907, "per_million": 1855.8032005330463, "ratio": 0.6702191681133326, "median": 2768.949753790441 }, "scores": { "safety": { "score": 45, "letter": "F", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "1,856 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site", "Death share in reports is near or below the FAERS average (0.5x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)", "3 Class I recall(s): reasonable probability of serious harm (-20)" ], "weight": 0.35 }, "evidence": { "score": 70, "letter": "C", "why": [ "642 randomized trials and 39 systematic reviews/meta-analyses indexed in PubMed", "2 independent Cochrane review(s) exist", "Only 41% of completed registered trials posted results (-8)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 62, "letter": "D", "why": [ "Recalls since 2016: 3 Class I, 8 Class II, 0 Class III across 57 generic makers (-30)", "5 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (57 applications)", "18 same-class alternatives exist" ], "weight": 0.1 } }, "total": 68, "grade": "C", "questions": [ "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are nausea, drug hypersensitivity. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over aceclofenac, acemetacin, bromfenac? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }