Latuda

N/A

Manufactured by Sumitomo Pharma America, Inc.

42,043 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Latuda

Latuda 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 Latuda 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 Latuda.

Top Adverse Reactions

OFF LABEL USE2,062 reports
DRUG INEFFECTIVE1,846 reports
ANXIETY1,233 reports
FEELING ABNORMAL1,168 reports
DEPRESSION1,131 reports
WEIGHT INCREASED1,091 reports
SOMNOLENCE1,072 reports
NAUSEA1,046 reports
INSOMNIA1,012 reports
SUICIDAL IDEATION968 reports
FATIGUE947 reports
DYSKINESIA825 reports
SUICIDE ATTEMPT759 reports
TREMOR708 reports
VOMITING674 reports
MALAISE660 reports
SEDATION618 reports
RESTLESSNESS603 reports
CONDITION AGGRAVATED601 reports
BLOOD GLUCOSE INCREASED587 reports
DYSTONIA571 reports
AKATHISIA569 reports
MANIA569 reports
TARDIVE DYSKINESIA562 reports
DIZZINESS549 reports
HEADACHE527 reports
SEXUAL DYSFUNCTION483 reports
SCHIZOPHRENIA468 reports
THERAPY CESSATION449 reports
AGITATION448 reports
METABOLIC DISORDER441 reports
ANOSOGNOSIA430 reports
BLOOD PROLACTIN ABNORMAL426 reports
PERSONALITY CHANGE416 reports
DISTURBANCE IN SOCIAL BEHAVIOUR415 reports
WEIGHT DECREASED414 reports
PAIN398 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS396 reports
DYSPNOEA374 reports
FALL361 reports
BIPOLAR DISORDER335 reports
PSYCHOTIC DISORDER334 reports
AGGRESSION322 reports
IRRITABILITY317 reports
DEPRESSED MOOD313 reports
MEMORY IMPAIRMENT306 reports
ANGER303 reports
ASTHENIA301 reports
CONFUSIONAL STATE299 reports
HALLUCINATION, AUDITORY292 reports
THERAPY INTERRUPTED292 reports
DIARRHOEA291 reports
CRYING284 reports
RASH281 reports
HALLUCINATION272 reports
PRODUCT USE IN UNAPPROVED INDICATION270 reports
MUSCLE SPASMS254 reports
HYPERHIDROSIS252 reports
DRUG INTERACTION251 reports
PANIC ATTACK250 reports
DECREASED APPETITE246 reports
MENTAL DISORDER246 reports
ADVERSE DRUG REACTION240 reports
COMPLETED SUICIDE239 reports
PRODUCT DOSE OMISSION238 reports
MUSCULOSKELETAL STIFFNESS224 reports
SEIZURE215 reports
GAIT DISTURBANCE211 reports
PRURITUS209 reports
ABNORMAL BEHAVIOUR208 reports
WITHDRAWAL SYNDROME207 reports
PAIN IN EXTREMITY196 reports
DISTURBANCE IN ATTENTION192 reports
ABDOMINAL DISCOMFORT184 reports
HYPERSENSITIVITY183 reports
PALPITATIONS183 reports
PARANOIA183 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION181 reports
RESTLESS LEGS SYNDROME177 reports
STRESS177 reports
VISION BLURRED176 reports
PRODUCT DOSE OMISSION ISSUE173 reports
EXTRAPYRAMIDAL DISORDER170 reports
MOOD SWINGS169 reports
MATERNAL EXPOSURE DURING PREGNANCY167 reports
DRUG DOSE OMISSION166 reports
HYPERSOMNIA166 reports
HYPERTENSION165 reports
ABDOMINAL PAIN UPPER164 reports
ARTHRALGIA162 reports
EMOTIONAL DISTRESS159 reports
SLEEP DISORDER159 reports
PYREXIA157 reports
DEATH155 reports
CHEST PAIN152 reports
LOSS OF CONSCIOUSNESS151 reports
URTICARIA151 reports
OVERDOSE150 reports
BACK PAIN148 reports
CONSTIPATION148 reports

Report Outcomes

Out of 20,651 classified reports for Latuda:

  • Serious: 9,172 reports (44.4%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 11,479 reports (55.6%)
Serious 44.4%Non-Serious 55.6%

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

Female11,374 (69.7%)
Male4,880 (29.9%)
Unknown70 (0.4%)

Reports by Age

Age 23391 reports
Age 32258 reports
Age 40193 reports
Age 50175 reports
Age 30172 reports
Age 35170 reports
Age 65169 reports
Age 37168 reports
Age 55163 reports
Age 39161 reports
Age 51158 reports
Age 49150 reports
Age 48148 reports
Age 43147 reports
Age 52147 reports
Age 53147 reports
Age 44146 reports
Age 59146 reports
Age 38143 reports
Age 42143 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 Latuda?

This profile reflects 42,043 FDA FAERS reports that mention Latuda. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Latuda?

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 Latuda?

Labeling and FAERS entries often list Sumitomo Pharma America, Inc. in connection with Latuda. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Sumitomo Pharma America, Inc.

Explore other medications manufactured by Sumitomo Pharma America, Inc. and compare their safety profiles:

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Drugs Also Linked to OFF LABEL USE

The following drugs share commonly reported adverse reactions with Latuda:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABATACEPT (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACALABRUTINIB (78/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE (65/100)

View all drugs reporting OFF LABEL USE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsSumitomo Pharma America, Inc. PortfolioOFF LABEL USE in Other DrugsDRUG INEFFECTIVE in Other DrugsANXIETY in Other Drugs
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.