Drug Safety Information for TORADOL (Ketorolac tromethamine)

Safety-related Labeling Changes for ACULAR LS (KETOROLAC TROMETHAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for SPRIX (KETOROLAC TROMETHAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for OMIDRIA (KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for TORADOL* (Ketorolac tromethamine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TORADOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*657
2Anxiety434
3Injury416
4Nausea*405
5Dyspnoea375
6Pulmonary embolism348
7Vomiting307
8Headache307
9Emotional distress248
10Depression243
11Back pain243
12Fatigue*239
13Chest pain239
14Deep vein thrombosis234
15Abdominal pain220
16Dizziness*219
17Drug hypersensitivity205
18Pain in extremity201
19Diarrhoea198
20Drug ineffective*197

* This side effect also appears in "Top 10 Side Effects of TORADOL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TORADOL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2929
2Pain2538
3Migraine*535
4Headache*483
5Back pain*267
6Analgesic therapy223
7Cataract operation218
8Abdominal pain208
9Procedural pain206
10Postoperative care147

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TORADOL

Total Reports Filed with FDA: 37487


Number of FDA Adverse Event Reports by Patient Age for TORADOL

Total Reports Filed with FDA: 37487*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ketorolac tromethamine (Acular, Ketorolac, Sprix, Acuvail, Toradol, Acular ls)

Charts are based on 37487 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and TORADOL Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.