BUSPIRONE HYDROCHLORIDE

N/A

Manufactured by Advagen Pharma Ltd

22,107 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BUSPIRONE HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Ltd. The most commonly reported adverse reactions for BUSPIRONE HYDROCHLORIDE include FATIGUE, NAUSEA, HEADACHE, ANXIETY, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUSPIRONE HYDROCHLORIDE.

Top Adverse Reactions

FATIGUE760 reports
NAUSEA745 reports
HEADACHE676 reports
ANXIETY636 reports
DRUG INEFFECTIVE634 reports
PAIN542 reports
DYSPNOEA518 reports
DEPRESSION477 reports
DIZZINESS472 reports
DIARRHOEA465 reports
PRODUCT DOSE OMISSION ISSUE434 reports
FALL389 reports
OFF LABEL USE337 reports
VOMITING323 reports
INSOMNIA320 reports
MALAISE320 reports
ARTHRALGIA313 reports
FEELING ABNORMAL311 reports
COUGH300 reports
PRURITUS293 reports
WEIGHT DECREASED291 reports
PNEUMONIA287 reports
WEIGHT INCREASED280 reports
CONDITION AGGRAVATED277 reports
TREMOR274 reports
BACK PAIN268 reports
RASH262 reports
SOMNOLENCE259 reports
COMPLETED SUICIDE246 reports
SUICIDAL IDEATION246 reports
ASTHENIA244 reports
SINUSITIS243 reports
PAIN IN EXTREMITY230 reports
URINARY TRACT INFECTION221 reports
COVID 19217 reports
DEATH216 reports
PRODUCT USE IN UNAPPROVED INDICATION212 reports
HYPERTENSION210 reports
DECREASED APPETITE205 reports
PYREXIA203 reports
ILLNESS195 reports
NASOPHARYNGITIS193 reports
ABDOMINAL DISCOMFORT187 reports
BLOOD PRESSURE INCREASED187 reports
MIGRAINE182 reports
INJECTION SITE PAIN176 reports
CHEST PAIN172 reports
CONSTIPATION169 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION168 reports
MUSCLE SPASMS163 reports
ASTHMA162 reports
PERIPHERAL SWELLING160 reports
SURGERY160 reports
MEMORY IMPAIRMENT159 reports
DRUG INTERACTION154 reports
GAIT DISTURBANCE154 reports
CONFUSIONAL STATE148 reports
ABDOMINAL PAIN UPPER147 reports
HYPOTENSION147 reports
DRUG HYPERSENSITIVITY145 reports
HOSPITALISATION144 reports
HYPERHIDROSIS143 reports
INFLUENZA142 reports
PRODUCT ADMINISTRATION INTERRUPTED139 reports
BRONCHITIS136 reports
SLEEP APNOEA SYNDROME136 reports
PRE EXISTING CONDITION IMPROVED134 reports
HYPERSENSITIVITY131 reports
VISION BLURRED129 reports
HYPOAESTHESIA126 reports
LOSS OF CONSCIOUSNESS126 reports
DIABETES MELLITUS124 reports
GASTROOESOPHAGEAL REFLUX DISEASE123 reports
ABDOMINAL PAIN120 reports
DRY SKIN119 reports
FLUSHING119 reports
SEROTONIN SYNDROME118 reports
PRODUCT USE ISSUE117 reports
PALPITATIONS115 reports
TOXICITY TO VARIOUS AGENTS115 reports
PARAESTHESIA114 reports
AGITATION112 reports
OVERDOSE112 reports
MYALGIA111 reports
NEUROPATHY PERIPHERAL111 reports
UNEVALUABLE EVENT110 reports
DEHYDRATION107 reports
BALANCE DISORDER106 reports
HEART RATE INCREASED106 reports
THERAPEUTIC RESPONSE UNEXPECTED103 reports
ALOPECIA100 reports
EYE PAIN99 reports
DISTURBANCE IN ATTENTION98 reports
HALLUCINATION98 reports
OROPHARYNGEAL PAIN98 reports
NEPHROLITHIASIS97 reports
RENAL FAILURE97 reports
VISUAL IMPAIRMENT97 reports
UPPER RESPIRATORY TRACT INFECTION96 reports
CHRONIC KIDNEY DISEASE95 reports

Report Outcomes

Out of 10,214 classified reports for BUSPIRONE HYDROCHLORIDE:

Serious 56.4%Non-Serious 43.6%

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

Female7,177 (74.7%)
Male2,426 (25.2%)
Unknown9 (0.1%)

Reports by Age

Age 62137 reports
Age 58134 reports
Age 52129 reports
Age 50128 reports
Age 59122 reports
Age 51121 reports
Age 60116 reports
Age 63116 reports
Age 49113 reports
Age 56113 reports
Age 61112 reports
Age 39110 reports
Age 44106 reports
Age 55104 reports
Age 57104 reports
Age 64104 reports
Age 65104 reports
Age 66103 reports
Age 68103 reports
Age 48102 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 BUSPIRONE HYDROCHLORIDE?

This profile reflects 22,107 FDA FAERS reports that mention BUSPIRONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUSPIRONE HYDROCHLORIDE?

Frequently reported terms in FAERS include FATIGUE, NAUSEA, HEADACHE, ANXIETY, DRUG INEFFECTIVE, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUSPIRONE HYDROCHLORIDE?

Labeling and FAERS entries often list Advagen Pharma Ltd in connection with BUSPIRONE 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.