ISTRADEFYLLINE

N/A

Manufactured by Kyowa Kirin, Inc.

10,328 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ISTRADEFYLLINE

ISTRADEFYLLINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kyowa Kirin, Inc.. The most commonly reported adverse reactions for ISTRADEFYLLINE include DEATH, DRUG INEFFECTIVE, HALLUCINATION, DYSKINESIA, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ISTRADEFYLLINE.

Top Adverse Reactions

DEATH677 reports
DRUG INEFFECTIVE617 reports
HALLUCINATION595 reports
DYSKINESIA476 reports
CONDITION AGGRAVATED445 reports
DIZZINESS416 reports
PRODUCT DOSE OMISSION ISSUE352 reports
CONSTIPATION351 reports
FALL330 reports
TREMOR259 reports
THERAPY NON RESPONDER252 reports
INSOMNIA225 reports
FATIGUE200 reports
NAUSEA195 reports
PARKINSON^S DISEASE177 reports
GAIT DISTURBANCE170 reports
CONFUSIONAL STATE142 reports
ADVERSE DRUG REACTION137 reports
DISEASE PROGRESSION134 reports
SOMNOLENCE134 reports
HOSPITALISATION126 reports
ASTHENIA124 reports
BALANCE DISORDER119 reports
FEELING ABNORMAL112 reports
SLEEP DISORDER110 reports
FREEZING PHENOMENON87 reports
MALAISE87 reports
ON AND OFF PHENOMENON84 reports
ANXIETY82 reports
HEADACHE82 reports
URINARY TRACT INFECTION79 reports
ADVERSE EVENT77 reports
HALLUCINATION, VISUAL74 reports
PRODUCT DISPENSING ERROR73 reports
EMERGENCY CARE72 reports
DIARRHOEA69 reports
COUGH68 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION66 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS64 reports
ABDOMINAL DISCOMFORT60 reports
AGITATION60 reports
MUSCULOSKELETAL STIFFNESS60 reports
PERIPHERAL SWELLING60 reports
DRY MOUTH57 reports
DYSPNOEA55 reports
PRODUCT USE IN UNAPPROVED INDICATION55 reports
PNEUMONIA54 reports
PRODUCT DISPENSING ISSUE54 reports
HYPOTENSION53 reports
MEMORY IMPAIRMENT53 reports
PRODUCT DOSE OMISSION52 reports
DECREASED APPETITE51 reports
DYSPHAGIA51 reports
RASH51 reports
COVID 1949 reports
WEIGHT DECREASED49 reports
VOMITING48 reports
DELUSION47 reports
MUSCLE SPASMS46 reports
MUSCULAR WEAKNESS46 reports
MOVEMENT DISORDER45 reports
NIGHTMARE44 reports
PAIN43 reports
DEVICE ISSUE41 reports
SPEECH DISORDER41 reports
PAIN IN EXTREMITY40 reports
DEPRESSION39 reports
CEREBROVASCULAR ACCIDENT37 reports
PRODUCT USE ISSUE37 reports
DRUG INTERACTION36 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE36 reports
IMPULSE CONTROL DISORDER35 reports
MOBILITY DECREASED34 reports
THERAPEUTIC RESPONSE SHORTENED34 reports
HIP FRACTURE33 reports
LOSS OF CONSCIOUSNESS33 reports
ABNORMAL DREAMS32 reports
DELIRIUM32 reports
HOSPICE CARE32 reports
BLOOD PRESSURE INCREASED31 reports
GAIT INABILITY31 reports
ILLNESS31 reports
ABDOMINAL PAIN UPPER30 reports
HEAD INJURY30 reports
HYPOAESTHESIA30 reports
DISORIENTATION29 reports
LETHARGY29 reports
OFF LABEL USE29 reports
AGGRESSION28 reports
DEMENTIA28 reports
THERAPY PARTIAL RESPONDER28 reports
THERAPY CESSATION26 reports
HYPERTENSION25 reports
PRURITUS25 reports
ABNORMAL BEHAVIOUR24 reports
BACK PAIN24 reports
COGNITIVE DISORDER24 reports
PNEUMONIA ASPIRATION24 reports
SURGERY24 reports
VISUAL IMPAIRMENT24 reports

Report Outcomes

Out of 5,771 classified reports for ISTRADEFYLLINE:

Serious 43.3%Non-Serious 56.7%

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

Male508 (59.7%)
Female343 (40.3%)

Reports by Age

Age 7027 reports
Age 7327 reports
Age 7725 reports
Age 7223 reports
Age 8023 reports
Age 8322 reports
Age 6521 reports
Age 7521 reports
Age 7120 reports
Age 7620 reports
Age 6618 reports
Age 7918 reports
Age 8218 reports
Age 8417 reports
Age 7816 reports
Age 6814 reports
Age 7414 reports
Age 5713 reports
Age 6713 reports
Age 812 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 ISTRADEFYLLINE?

This profile reflects 10,328 FDA FAERS reports that mention ISTRADEFYLLINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ISTRADEFYLLINE?

Frequently reported terms in FAERS include DEATH, DRUG INEFFECTIVE, HALLUCINATION, DYSKINESIA, CONDITION AGGRAVATED, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ISTRADEFYLLINE?

Labeling and FAERS entries often list Kyowa Kirin, Inc. in connection with ISTRADEFYLLINE. 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.