ESKETAMINE HYDROCHLORIDE

N/A

Manufactured by Janssen Pharmaceuticals Inc.

24,470 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ESKETAMINE HYDROCHLORIDE

ESKETAMINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals Inc.. The most commonly reported adverse reactions for ESKETAMINE HYDROCHLORIDE include DISSOCIATION, SEDATION, SUICIDAL IDEATION, DRUG INEFFECTIVE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESKETAMINE HYDROCHLORIDE.

Top Adverse Reactions

DISSOCIATION3,351 reports
SEDATION2,465 reports
SUICIDAL IDEATION1,233 reports
DRUG INEFFECTIVE1,032 reports
NAUSEA876 reports
DEPRESSION808 reports
PRODUCT DOSE OMISSION ISSUE709 reports
HOSPITALISATION702 reports
HYPERTENSION688 reports
ANXIETY681 reports
VOMITING643 reports
DIZZINESS597 reports
BLOOD PRESSURE INCREASED518 reports
FEELING ABNORMAL455 reports
OFF LABEL USE365 reports
HEADACHE306 reports
DEATH291 reports
SUICIDE ATTEMPT289 reports
FATIGUE276 reports
ADVERSE EVENT275 reports
PANIC ATTACK270 reports
HALLUCINATION266 reports
SURGERY243 reports
COMPLETED SUICIDE231 reports
DEVICE ISSUE228 reports
SOMNOLENCE210 reports
HALLUCINATION, VISUAL186 reports
FALL179 reports
DEVICE MALFUNCTION169 reports
INCORRECT DOSE ADMINISTERED BY DEVICE165 reports
INSOMNIA158 reports
UNDERDOSE145 reports
SEIZURE143 reports
HYPOAESTHESIA137 reports
EUPHORIC MOOD134 reports
TREATMENT NONCOMPLIANCE129 reports
MALAISE124 reports
CRYING123 reports
TREMOR113 reports
LOSS OF CONSCIOUSNESS111 reports
AGITATION109 reports
MAJOR DEPRESSION109 reports
DYSPNOEA107 reports
HYPERHIDROSIS105 reports
COVID 19103 reports
DEPRESSED MOOD100 reports
CHEST PAIN99 reports
MEMORY IMPAIRMENT99 reports
THERAPEUTIC PRODUCT EFFECT DECREASED99 reports
ILLNESS97 reports
MIGRAINE91 reports
TASTE DISORDER91 reports
HYPOTENSION90 reports
VERTIGO90 reports
PAIN89 reports
CONFUSIONAL STATE86 reports
DYSGEUSIA86 reports
PSYCHOTIC DISORDER86 reports
VISION BLURRED85 reports
DISSOCIATIVE DISORDER83 reports
ADVERSE DRUG REACTION82 reports
EXPOSURE DURING PREGNANCY82 reports
MENTAL DISORDER81 reports
PARAESTHESIA80 reports
THERAPEUTIC RESPONSE DECREASED79 reports
OVERDOSE78 reports
ASTHENIA76 reports
DRUG ABUSE76 reports
CONDITION AGGRAVATED72 reports
NEOPLASM MALIGNANT72 reports
INCORRECT DOSE ADMINISTERED71 reports
FEELING DRUNK69 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION69 reports
CEREBROVASCULAR ACCIDENT65 reports
GAIT DISTURBANCE62 reports
PHYSICAL EXAMINATION ABNORMAL62 reports
HEART RATE INCREASED61 reports
INTENTIONAL SELF INJURY61 reports
NASAL DISCOMFORT61 reports
SYNCOPE61 reports
MANIA60 reports
PNEUMONIA60 reports
PRODUCT QUALITY ISSUE60 reports
MENTAL IMPAIRMENT58 reports
ROAD TRAFFIC ACCIDENT58 reports
DYSARTHRIA57 reports
EPISTAXIS57 reports
IRRITABILITY57 reports
MYOCARDIAL INFARCTION57 reports
UNRESPONSIVE TO STIMULI57 reports
POLLAKIURIA56 reports
SPINAL OPERATION56 reports
EMOTIONAL DISORDER55 reports
UNEVALUABLE EVENT55 reports
BLOOD PRESSURE DECREASED54 reports
PRODUCT DOSE OMISSION54 reports
WITHDRAWAL SYNDROME54 reports
ANGER53 reports
DRUG INTERACTION52 reports
FEAR52 reports

Report Outcomes

Out of 15,775 classified reports for ESKETAMINE HYDROCHLORIDE:

Serious 69.5%Non-Serious 30.5%

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

Female8,844 (66.0%)
Male4,563 (34.0%)
Unknown1 (0.0%)

Reports by Age

Age 43261 reports
Age 44255 reports
Age 40246 reports
Age 6235 reports
Age 55235 reports
Age 42229 reports
Age 61217 reports
Age 5216 reports
Age 47212 reports
Age 45210 reports
Age 60210 reports
Age 46209 reports
Age 48206 reports
Age 49205 reports
Age 54205 reports
Age 38204 reports
Age 41203 reports
Age 50202 reports
Age 57202 reports
Age 36200 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 ESKETAMINE HYDROCHLORIDE?

This profile reflects 24,470 FDA FAERS reports that mention ESKETAMINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ESKETAMINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DISSOCIATION, SEDATION, SUICIDAL IDEATION, DRUG INEFFECTIVE, NAUSEA, DEPRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ESKETAMINE HYDROCHLORIDE?

Labeling and FAERS entries often list Janssen Pharmaceuticals Inc. in connection with ESKETAMINE 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.