LURASIDONE HYDROCHLORIDE

N/A

Manufactured by Sumitomo Pharma America, Inc.

41,710 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LURASIDONE HYDROCHLORIDE

LURASIDONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sumitomo Pharma America, Inc.. The most commonly reported adverse reactions for LURASIDONE HYDROCHLORIDE include OFF LABEL USE, DRUG INEFFECTIVE, ANXIETY, FEELING ABNORMAL, DEPRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LURASIDONE HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE2,055 reports
DRUG INEFFECTIVE1,834 reports
ANXIETY1,223 reports
FEELING ABNORMAL1,166 reports
DEPRESSION1,120 reports
WEIGHT INCREASED1,077 reports
SOMNOLENCE1,066 reports
NAUSEA1,037 reports
INSOMNIA1,002 reports
SUICIDAL IDEATION957 reports
FATIGUE942 reports
DYSKINESIA818 reports
SUICIDE ATTEMPT751 reports
TREMOR705 reports
VOMITING665 reports
MALAISE659 reports
SEDATION613 reports
RESTLESSNESS600 reports
CONDITION AGGRAVATED591 reports
BLOOD GLUCOSE INCREASED584 reports
MANIA568 reports
DYSTONIA567 reports
TARDIVE DYSKINESIA561 reports
AKATHISIA551 reports
DIZZINESS546 reports
HEADACHE526 reports
SEXUAL DYSFUNCTION480 reports
SCHIZOPHRENIA463 reports
THERAPY CESSATION449 reports
AGITATION447 reports
METABOLIC DISORDER437 reports
ANOSOGNOSIA427 reports
BLOOD PROLACTIN ABNORMAL423 reports
PERSONALITY CHANGE413 reports
DISTURBANCE IN SOCIAL BEHAVIOUR412 reports
WEIGHT DECREASED411 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS394 reports
PAIN392 reports
DYSPNOEA373 reports
FALL358 reports
PSYCHOTIC DISORDER334 reports
BIPOLAR DISORDER332 reports
AGGRESSION322 reports
IRRITABILITY314 reports
DEPRESSED MOOD311 reports
MEMORY IMPAIRMENT303 reports
ANGER301 reports
ASTHENIA300 reports
CONFUSIONAL STATE298 reports
THERAPY INTERRUPTED291 reports
HALLUCINATION, AUDITORY286 reports
DIARRHOEA284 reports
CRYING281 reports
RASH280 reports
HALLUCINATION271 reports
PRODUCT USE IN UNAPPROVED INDICATION261 reports
MUSCLE SPASMS254 reports
DRUG INTERACTION251 reports
HYPERHIDROSIS246 reports
PANIC ATTACK246 reports
DECREASED APPETITE245 reports
MENTAL DISORDER240 reports
PRODUCT DOSE OMISSION238 reports
COMPLETED SUICIDE237 reports
ADVERSE DRUG REACTION235 reports
MUSCULOSKELETAL STIFFNESS223 reports
SEIZURE213 reports
GAIT DISTURBANCE209 reports
PRURITUS207 reports
WITHDRAWAL SYNDROME207 reports
ABNORMAL BEHAVIOUR206 reports
PAIN IN EXTREMITY192 reports
DISTURBANCE IN ATTENTION190 reports
ABDOMINAL DISCOMFORT183 reports
HYPERSENSITIVITY183 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION181 reports
PALPITATIONS180 reports
RESTLESS LEGS SYNDROME177 reports
VISION BLURRED175 reports
PARANOIA173 reports
STRESS173 reports
PRODUCT DOSE OMISSION ISSUE171 reports
EXTRAPYRAMIDAL DISORDER169 reports
MOOD SWINGS169 reports
DRUG DOSE OMISSION166 reports
MATERNAL EXPOSURE DURING PREGNANCY166 reports
HYPERTENSION165 reports
HYPERSOMNIA163 reports
ABDOMINAL PAIN UPPER162 reports
ARTHRALGIA162 reports
SLEEP DISORDER158 reports
PYREXIA157 reports
EMOTIONAL DISTRESS156 reports
DEATH153 reports
CHEST PAIN152 reports
LOSS OF CONSCIOUSNESS150 reports
URTICARIA150 reports
OVERDOSE149 reports
BACK PAIN148 reports
NERVOUSNESS148 reports

Report Outcomes

Out of 20,541 classified reports for LURASIDONE HYDROCHLORIDE:

Serious 44.3%Non-Serious 55.7%

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

Female11,298 (69.6%)
Male4,861 (30.0%)
Unknown70 (0.4%)

Reports by Age

Age 23385 reports
Age 32256 reports
Age 40187 reports
Age 50174 reports
Age 30171 reports
Age 35170 reports
Age 37166 reports
Age 55163 reports
Age 65161 reports
Age 39157 reports
Age 51155 reports
Age 49149 reports
Age 48147 reports
Age 53147 reports
Age 52146 reports
Age 59146 reports
Age 43145 reports
Age 44144 reports
Age 42143 reports
Age 38141 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 LURASIDONE HYDROCHLORIDE?

This profile reflects 41,710 FDA FAERS reports that mention LURASIDONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LURASIDONE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, ANXIETY, FEELING ABNORMAL, DEPRESSION, WEIGHT INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LURASIDONE HYDROCHLORIDE?

Labeling and FAERS entries often list Sumitomo Pharma America, Inc. in connection with LURASIDONE 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.