KETAMINE HYDROCHLORIDE

N/A

Manufactured by Par Health USA, LLC

11,206 FDA adverse event reports analyzed

Last updated: 2026-04-15

About KETAMINE HYDROCHLORIDE

KETAMINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Par Health USA, LLC. The most commonly reported adverse reactions for KETAMINE HYDROCHLORIDE include INFUSION SITE PAIN, DRUG INEFFECTIVE, OFF LABEL USE, NAUSEA, INFUSION SITE ERYTHEMA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for KETAMINE HYDROCHLORIDE.

Top Adverse Reactions

INFUSION SITE PAIN640 reports
DRUG INEFFECTIVE465 reports
OFF LABEL USE439 reports
NAUSEA430 reports
INFUSION SITE ERYTHEMA398 reports
HEADACHE274 reports
DRUG ABUSE271 reports
INFUSION SITE SWELLING270 reports
DIARRHOEA259 reports
DYSPNOEA259 reports
FATIGUE200 reports
HYPOTENSION190 reports
VOMITING189 reports
INFUSION SITE HAEMORRHAGE185 reports
PAIN173 reports
HYPERHIDROSIS168 reports
SEDATION164 reports
DIZZINESS161 reports
NIGHTMARE149 reports
PRODUCT USE IN UNAPPROVED INDICATION139 reports
NEPHROLITHIASIS134 reports
INFUSION SITE INFECTION125 reports
INFUSION SITE DISCHARGE123 reports
THERAPY NON RESPONDER116 reports
DEVICE DISLOCATION112 reports
HYDRONEPHROSIS112 reports
DEVICE FAILURE107 reports
PAIN IN EXTREMITY102 reports
DEVICE ISSUE101 reports
ANAPHYLACTIC SHOCK97 reports
CONDITION AGGRAVATED96 reports
DEVICE INFUSION ISSUE96 reports
INFUSION SITE INDURATION95 reports
INFUSION SITE REACTION95 reports
WEIGHT DECREASED93 reports
MALAISE92 reports
DECREASED APPETITE91 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION90 reports
RASH89 reports
DEATH87 reports
TOXICITY TO VARIOUS AGENTS87 reports
DERMATITIS CONTACT86 reports
INFUSION SITE PRURITUS84 reports
OXYGEN SATURATION DECREASED82 reports
ANXIETY81 reports
DEVICE LEAKAGE81 reports
DEVICE OCCLUSION81 reports
PYREXIA81 reports
DEVICE MAINTENANCE ISSUE80 reports
INFUSION SITE IRRITATION80 reports
CYSTITIS79 reports
ASTHENIA78 reports
RESPIRATORY FAILURE78 reports
BACK PAIN73 reports
DEVICE USE ERROR71 reports
FEELING ABNORMAL70 reports
DEVICE MALFUNCTION69 reports
PAIN IN JAW69 reports
INFUSION SITE WARMTH67 reports
TACHYCARDIA67 reports
ABDOMINAL DISTENSION66 reports
CARDIAC ARREST65 reports
DRUG INTERACTION65 reports
ARTHRALGIA64 reports
PNEUMONIA64 reports
COUGH63 reports
INSPIRATORY CAPACITY DECREASED63 reports
INSOMNIA60 reports
ILLNESS59 reports
DEVICE POWER SOURCE ISSUE58 reports
DRUG HYPERSENSITIVITY58 reports
HYPOXIA58 reports
ABDOMINAL PAIN57 reports
CHEST PAIN56 reports
ACUTE KIDNEY INJURY55 reports
DEVICE WIRELESS COMMUNICATION ISSUE55 reports
PURULENT DISCHARGE54 reports
SHOCK54 reports
SOMNOLENCE54 reports
URTICARIA54 reports
WEIGHT INCREASED54 reports
EPISTAXIS53 reports
PERIPHERAL SWELLING53 reports
DEVICE DIFFICULT TO USE52 reports
ERYTHEMA52 reports
CONSTIPATION51 reports
DELIRIUM51 reports
FLUSHING51 reports
METABOLIC ACIDOSIS51 reports
BILIARY TRACT DISORDER50 reports
HAEMATURIA50 reports
LIVER FUNCTION TEST ABNORMAL50 reports
DYSPNOEA EXERTIONAL49 reports
FALL49 reports
BLADDER DISORDER48 reports
HYPERSENSITIVITY48 reports
INFUSION SITE DISCOLOURATION48 reports
INFUSION SITE NODULE48 reports
PRODUCT USE ISSUE48 reports
SEPSIS48 reports

Report Outcomes

Out of 4,329 classified reports for KETAMINE HYDROCHLORIDE:

Serious 72.3%Non-Serious 27.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,360 (59.8%)
Male1,561 (39.5%)
Unknown26 (0.7%)

Reports by Age

Age 53136 reports
Age 2775 reports
Age 1970 reports
Age 5865 reports
Age 2857 reports
Age 6057 reports
Age 3056 reports
Age 7551 reports
Age 4450 reports
Age 5049 reports
Age 3748 reports
Age 5548 reports
Age 5648 reports
Age 347 reports
Age 3547 reports
Age 4845 reports
Age 4744 reports
Age 3143 reports
Age 5241 reports
Age 2440 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with KETAMINE HYDROCHLORIDE?

This profile reflects 11,206 FDA FAERS reports that mention KETAMINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for KETAMINE HYDROCHLORIDE?

Frequently reported terms in FAERS include INFUSION SITE PAIN, DRUG INEFFECTIVE, OFF LABEL USE, NAUSEA, INFUSION SITE ERYTHEMA, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures KETAMINE HYDROCHLORIDE?

Labeling and FAERS entries often list Par Health USA, LLC in connection with KETAMINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.