GUANFACINE

N/A

Manufactured by Takeda Pharmaceuticals America, Inc.

13,968 FDA adverse event reports analyzed

Last updated: 2026-04-15

About GUANFACINE

GUANFACINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. The most commonly reported adverse reactions for GUANFACINE include DRUG INEFFECTIVE, OFF LABEL USE, SOMNOLENCE, AGGRESSION, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GUANFACINE.

Top Adverse Reactions

DRUG INEFFECTIVE778 reports
OFF LABEL USE598 reports
SOMNOLENCE455 reports
AGGRESSION376 reports
FATIGUE329 reports
HYPOTENSION289 reports
DIZZINESS270 reports
HEADACHE268 reports
INSOMNIA264 reports
SUICIDAL IDEATION259 reports
ANXIETY250 reports
BRADYCARDIA249 reports
NAUSEA245 reports
ABNORMAL BEHAVIOUR215 reports
TOXICITY TO VARIOUS AGENTS213 reports
INTENTIONAL OVERDOSE212 reports
ELECTROCARDIOGRAM QT PROLONGED211 reports
NO ADVERSE EVENT208 reports
PRODUCT QUALITY ISSUE206 reports
VOMITING201 reports
AGITATION197 reports
WEIGHT INCREASED196 reports
CONDITION AGGRAVATED186 reports
DECREASED APPETITE177 reports
PRODUCT SUBSTITUTION ISSUE173 reports
PRODUCT USE ISSUE172 reports
SYNCOPE170 reports
DEPRESSION168 reports
IRRITABILITY161 reports
OVERDOSE159 reports
DRUG INTERACTION152 reports
ANGER151 reports
SEIZURE148 reports
PRODUCT DOSE OMISSION ISSUE143 reports
PSYCHOMOTOR HYPERACTIVITY136 reports
BLOOD PRESSURE DECREASED135 reports
DISTURBANCE IN ATTENTION135 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS130 reports
DIARRHOEA129 reports
PRODUCT USE IN UNAPPROVED INDICATION125 reports
RASH121 reports
MALAISE120 reports
FEELING ABNORMAL119 reports
HYPERTENSION118 reports
SUICIDE ATTEMPT115 reports
WEIGHT DECREASED115 reports
CONSTIPATION112 reports
TIC110 reports
FALL109 reports
LETHARGY106 reports
DYSPNOEA100 reports
LOSS OF CONSCIOUSNESS98 reports
HALLUCINATION97 reports
DRUG DOSE OMISSION96 reports
SEDATION96 reports
ABDOMINAL PAIN UPPER93 reports
HYPERHIDROSIS93 reports
ASTHENIA86 reports
INCORRECT DOSE ADMINISTERED86 reports
TACHYCARDIA86 reports
INTENTIONAL SELF INJURY84 reports
PAIN84 reports
ABDOMINAL PAIN81 reports
PRURITUS80 reports
BLOOD PRESSURE INCREASED79 reports
TREMOR79 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS79 reports
PYREXIA78 reports
TREATMENT FAILURE75 reports
EMOTIONAL DISORDER73 reports
IMPULSIVE BEHAVIOUR73 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION72 reports
DEPRESSED MOOD71 reports
GYNAECOMASTIA71 reports
COMPLETED SUICIDE70 reports
COUGH70 reports
PNEUMONIA69 reports
SINUS BRADYCARDIA69 reports
WITHDRAWAL SYNDROME69 reports
SLEEP DISORDER68 reports
CHEST PAIN65 reports
ARRHYTHMIA61 reports
MOOD SWINGS61 reports
PALPITATIONS61 reports
RESTLESSNESS61 reports
DEPRESSED LEVEL OF CONSCIOUSNESS60 reports
HOSPITALISATION60 reports
PAIN IN EXTREMITY60 reports
DISTURBANCE IN SOCIAL BEHAVIOUR59 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION58 reports
DEHYDRATION57 reports
ABDOMINAL DISCOMFORT56 reports
CRYING56 reports
DYSTONIA56 reports
MENTAL DISORDER56 reports
DRUG EFFECT DECREASED55 reports
HYPERSENSITIVITY55 reports
ARTHRALGIA54 reports
HEART RATE INCREASED54 reports
INJECTION SITE PAIN54 reports

Report Outcomes

Out of 7,383 classified reports for GUANFACINE:

Serious 59.2%Non-Serious 40.8%

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

Male3,811 (62.2%)
Female2,210 (36.1%)
Unknown102 (1.7%)

Reports by Age

Age 11297 reports
Age 10286 reports
Age 9284 reports
Age 8278 reports
Age 12263 reports
Age 14232 reports
Age 15215 reports
Age 16215 reports
Age 17202 reports
Age 6184 reports
Age 7177 reports
Age 13175 reports
Age 594 reports
Age 1880 reports
Age 2373 reports
Age 1970 reports
Age 2059 reports
Age 3052 reports
Age 450 reports
Age 2149 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 GUANFACINE?

This profile reflects 13,968 FDA FAERS reports that mention GUANFACINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GUANFACINE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, OFF LABEL USE, SOMNOLENCE, AGGRESSION, FATIGUE, HYPOTENSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GUANFACINE?

Labeling and FAERS entries often list Takeda Pharmaceuticals America, Inc. in connection with GUANFACINE. 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.