SILODOSIN

N/A

Manufactured by Ajanta Pharma USA Inc.

5,716 FDA adverse event reports analyzed

Last updated: 2026-04-15

About SILODOSIN

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

Top Adverse Reactions

OFF LABEL USE168 reports
DIARRHOEA146 reports
FATIGUE137 reports
DRUG INEFFECTIVE136 reports
DIZZINESS133 reports
ACUTE KIDNEY INJURY123 reports
ASTHENIA118 reports
DRUG INTERACTION118 reports
ANAEMIA116 reports
HYPOTENSION116 reports
URINARY RETENTION115 reports
PYREXIA114 reports
FALL109 reports
DEATH104 reports
DYSPNOEA100 reports
DECREASED APPETITE92 reports
NAUSEA92 reports
PNEUMONIA90 reports
HEADACHE84 reports
MALAISE83 reports
PRURITUS75 reports
CONFUSIONAL STATE73 reports
SYNCOPE72 reports
CONSTIPATION71 reports
RASH71 reports
URINARY TRACT INFECTION71 reports
WEIGHT DECREASED68 reports
ERECTILE DYSFUNCTION67 reports
INTERSTITIAL LUNG DISEASE67 reports
HYPERTENSION65 reports
HYPONATRAEMIA61 reports
ATRIAL FIBRILLATION59 reports
NEUTROPENIA56 reports
CONDITION AGGRAVATED55 reports
DEHYDRATION54 reports
HAEMATURIA52 reports
COVID 1951 reports
ARTHRALGIA50 reports
BRADYCARDIA50 reports
CARDIAC FAILURE50 reports
DYSURIA49 reports
OEDEMA PERIPHERAL49 reports
THROMBOCYTOPENIA49 reports
HOT FLUSH48 reports
ABDOMINAL PAIN UPPER46 reports
LOSS OF CONSCIOUSNESS46 reports
PLATELET COUNT DECREASED46 reports
ARRHYTHMIA45 reports
ORTHOSTATIC HYPOTENSION45 reports
SOMNOLENCE45 reports
CATARACT44 reports
BLOOD PRESSURE DECREASED43 reports
GENERAL PHYSICAL HEALTH DETERIORATION43 reports
HYPOKALAEMIA43 reports
PRODUCT USE ISSUE43 reports
SEIZURE42 reports
VOMITING42 reports
RENAL IMPAIRMENT41 reports
BACK PAIN40 reports
FEBRILE NEUTROPENIA40 reports
GAIT DISTURBANCE40 reports
COUGH39 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION39 reports
INSOMNIA38 reports
PAIN38 reports
PRODUCT USE IN UNAPPROVED INDICATION38 reports
ABDOMINAL PAIN37 reports
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION36 reports
PAIN IN EXTREMITY36 reports
PNEUMONIA ASPIRATION36 reports
BLOOD PRESSURE INCREASED35 reports
HEPATIC FUNCTION ABNORMAL35 reports
SEPSIS35 reports
WEIGHT INCREASED35 reports
CEREBRAL INFARCTION34 reports
DYSPHAGIA34 reports
HYPOGLYCAEMIA34 reports
RENAL FAILURE34 reports
CHEST PAIN33 reports
MALIGNANT NEOPLASM PROGRESSION33 reports
BLOOD CREATININE INCREASED32 reports
PLEURAL EFFUSION32 reports
RHABDOMYOLYSIS32 reports
PRESYNCOPE31 reports
HYPERKALAEMIA30 reports
HYPERHIDROSIS29 reports
NEUTROPHIL COUNT DECREASED29 reports
SOPOR29 reports
URTICARIA29 reports
BENIGN PROSTATIC HYPERPLASIA28 reports
ERYTHEMA28 reports
PANCYTOPENIA28 reports
PRODUCT DOSE OMISSION ISSUE28 reports
PROSTATIC SPECIFIC ANTIGEN INCREASED28 reports
VERTIGO28 reports
ACNE27 reports
BALANCE DISORDER27 reports
POLLAKIURIA27 reports
SKIN DISORDER27 reports
VISION BLURRED27 reports

Report Outcomes

Out of 3,651 classified reports for SILODOSIN:

Serious 88.3%Non-Serious 11.7%

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

Male3,233 (97.5%)
Female77 (2.3%)
Unknown6 (0.2%)

Reports by Age

Age 80149 reports
Age 81138 reports
Age 74135 reports
Age 77129 reports
Age 75126 reports
Age 70114 reports
Age 72114 reports
Age 71113 reports
Age 76110 reports
Age 82110 reports
Age 8494 reports
Age 7393 reports
Age 7991 reports
Age 7886 reports
Age 8379 reports
Age 6970 reports
Age 8669 reports
Age 6864 reports
Age 8563 reports
Age 8763 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 SILODOSIN?

This profile reflects 5,716 FDA FAERS reports that mention SILODOSIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SILODOSIN?

Frequently reported terms in FAERS include OFF LABEL USE, DIARRHOEA, FATIGUE, DRUG INEFFECTIVE, DIZZINESS, ACUTE KIDNEY INJURY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SILODOSIN?

Labeling and FAERS entries often list Ajanta Pharma USA Inc. in connection with SILODOSIN. 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.