GUANFACINE HYDROCHLORIDE

N/A

Manufactured by Amneal Pharmaceuticals LLC

8,032 FDA adverse event reports analyzed

Last updated: 2026-04-15

About GUANFACINE HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for GUANFACINE HYDROCHLORIDE 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 HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE513 reports
OFF LABEL USE365 reports
SOMNOLENCE211 reports
AGGRESSION209 reports
FATIGUE189 reports
TOXICITY TO VARIOUS AGENTS185 reports
HYPOTENSION176 reports
NAUSEA167 reports
ANXIETY156 reports
INSOMNIA150 reports
HEADACHE149 reports
AGITATION145 reports
DIZZINESS132 reports
CONDITION AGGRAVATED128 reports
DRUG INTERACTION126 reports
BRADYCARDIA123 reports
INTENTIONAL OVERDOSE118 reports
WEIGHT INCREASED116 reports
VOMITING112 reports
IRRITABILITY104 reports
PRODUCT DOSE OMISSION ISSUE102 reports
PRODUCT SUBSTITUTION ISSUE102 reports
DIARRHOEA100 reports
OVERDOSE99 reports
DEPRESSION98 reports
DECREASED APPETITE94 reports
ABNORMAL BEHAVIOUR93 reports
PRODUCT USE IN UNAPPROVED INDICATION93 reports
SUICIDAL IDEATION89 reports
HYPERTENSION85 reports
SEIZURE83 reports
RASH80 reports
ANGER78 reports
PRODUCT USE ISSUE76 reports
PRODUCT QUALITY ISSUE75 reports
WEIGHT DECREASED75 reports
CONSTIPATION70 reports
FALL70 reports
SUICIDE ATTEMPT66 reports
ELECTROCARDIOGRAM QT PROLONGED65 reports
LETHARGY65 reports
TREATMENT FAILURE65 reports
PAIN64 reports
ABDOMINAL PAIN UPPER61 reports
DYSPNOEA61 reports
PRURITUS61 reports
COMPLETED SUICIDE60 reports
PSYCHOMOTOR HYPERACTIVITY60 reports
SEDATION60 reports
MALAISE59 reports
HYPERHIDROSIS58 reports
NO ADVERSE EVENT57 reports
FEELING ABNORMAL56 reports
SINUS BRADYCARDIA56 reports
TREMOR56 reports
TACHYCARDIA55 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS55 reports
ASTHENIA54 reports
COUGH50 reports
PNEUMONIA50 reports
HALLUCINATION49 reports
TIC49 reports
COMA48 reports
DYSTONIA48 reports
DISTURBANCE IN ATTENTION47 reports
INCORRECT DOSE ADMINISTERED46 reports
EMOTIONAL DISORDER44 reports
INJECTION SITE PAIN44 reports
ABDOMINAL PAIN43 reports
BLOOD PRESSURE INCREASED43 reports
HYPERSENSITIVITY42 reports
PARAESTHESIA42 reports
PYREXIA42 reports
SLEEP DISORDER42 reports
ABDOMINAL DISCOMFORT41 reports
ARTHRALGIA41 reports
COVID 1941 reports
INTENTIONAL SELF INJURY41 reports
DRUG DOSE OMISSION BY DEVICE40 reports
GASTROINTESTINAL DISORDER40 reports
DEATH39 reports
DRY MOUTH39 reports
MOOD SWINGS39 reports
PAIN IN EXTREMITY39 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION38 reports
HOSPITALISATION38 reports
WITHDRAWAL SYNDROME38 reports
DEPRESSED LEVEL OF CONSCIOUSNESS37 reports
DRUG INTOLERANCE37 reports
NASOPHARYNGITIS37 reports
DEPRESSED MOOD36 reports
DYSARTHRIA36 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION36 reports
ILLNESS35 reports
IMPULSIVE BEHAVIOUR35 reports
BEHAVIOUR DISORDER34 reports
BLOOD PRESSURE DECREASED34 reports
DEHYDRATION34 reports
LOSS OF CONSCIOUSNESS34 reports
MENTAL DISORDER34 reports

Report Outcomes

Out of 4,100 classified reports for GUANFACINE HYDROCHLORIDE:

Serious 55.9%Non-Serious 44.1%

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

Male2,100 (59.2%)
Female1,377 (38.8%)
Unknown70 (2.0%)

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 HYDROCHLORIDE?

This profile reflects 8,032 FDA FAERS reports that mention GUANFACINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GUANFACINE HYDROCHLORIDE?

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

Who manufactures GUANFACINE HYDROCHLORIDE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with GUANFACINE 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.