Drug Safety Information for KETAMINE HYDROCHLORIDE (Ketamine hydrochloride)

Safety-related Labeling Changes for KETALAR (KETAMINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for KETAMINE HYDROCHLORIDE* (Ketamine hydrochloride)

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 KETAMINE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug abuse170
2Hypotension133
3Drug ineffective123
4Pain101
5Drug interaction99
6Toxicity to various agents93
7Hydronephrosis89
8Cardiac arrest87
9Renal failure acute82
10Post procedural complication77
11Anaphylactic shock76
12Nausea*75
13Haematuria73
14Bradycardia71
15Vomiting70
16Off label use70
17Cystitis68
18Tachycardia67
19Atrial fibrillation66
20Alanine aminotransferase increased64

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

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

Reason # of FDA Reports
1Product used for unknown indication981
2Drug abuse675
3Pain603
4Anaesthesia438
5General anaesthesia302
6Induction of anaesthesia300
7Sedation299
8Analgesic therapy266
9Substance use127
10Cancer pain122

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


Types of Adverse Events for KETAMINE HYDROCHLORIDE

Total Reports Filed with FDA: 10136


Number of FDA Adverse Event Reports by Patient Age for KETAMINE HYDROCHLORIDE

Total Reports Filed with FDA: 10136*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ketamine hydrochloride (Ketamine hcl , Ketamine hcl, Ketalar, Ketamine, Ketanest, Calypsol)

Charts are based on 10136 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 KETAMINE HYDROCHLORIDE 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.