Drug
Flutamide
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Prostatic Specific Antigen Increased | 60 | 92.6 | 98.5 | signal |
| 2 | Metastases To Bone | 36 | 46.9 | 48.7 | signal |
| 3 | Nephropathy | 12 | 27.3 | 27.6 | signal |
| 4 | Osteonecrosis Of Jaw | 26 | 22.2 | 22.8 | signal |
| 5 | Prostate Cancer | 70 | 18.4 | 19.7 | signal |
| 6 | Hyperlipidaemia | 9 | 16.0 | 16.1 | signal |
| 7 | Hepatic Encephalopathy | 7 | 16.0 | 16.1 | signal |
| 8 | Haematuria | 24 | 14.9 | 15.3 | signal |
| 9 | Sleep Apnoea Syndrome | 13 | 14.5 | 14.7 | signal |
| 10 | Cholecystitis | 8 | 14.3 | 14.4 | signal |
| 11 | Hypercalcaemia | 8 | 13.8 | 13.9 | signal |
| 12 | Hepatic Function Abnormal | 24 | 13.8 | 14.1 | signal |
| 13 | Intervertebral Disc Degeneration | 6 | 13.7 | 13.8 | signal |
| 14 | Blood Alkaline Phosphatase Increased | 16 | 13.7 | 13.9 | signal |
| 15 | Dental Caries | 7 | 13.5 | 13.6 | signal |
| 16 | Urinary Retention | 21 | 13.4 | 13.7 | signal |
| 17 | Interstitial Lung Disease | 30 | 13.2 | 13.6 | signal |
| 18 | Hepatomegaly | 6 | 12.9 | 13.0 | signal |
| 19 | Metastases To Lung | 7 | 12.9 | 13.0 | signal |
| 20 | Bone Disorder | 11 | 12.7 | 12.9 | signal |
| 21 | Intervertebral Disc Protrusion | 12 | 11.7 | 11.8 | signal |
| 22 | Anorexia | 7 | 11.4 | 11.5 | signal |
| 23 | Fistula | 6 | 11.3 | 11.4 | signal |
| 24 | Metastases To Liver | 9 | 10.9 | 11.0 | signal |
| 25 | Taste Disorder | 10 | 10.6 | 10.7 | signal |
| 26 | Osteomyelitis | 9 | 10.6 | 10.7 | signal |
| 27 | Tooth Abscess | 5 | 10.4 | 10.5 | signal |
| 28 | Myelodysplastic Syndrome | 7 | 10.3 | 10.4 | signal |
| 29 | Blood Lactate Dehydrogenase Increased | 7 | 9.3 | 9.4 | signal |
| 30 | Gastric Haemorrhage | 5 | 9.2 | 9.2 | signal |
| 31 | Hepatitis | 11 | 9.2 | 9.2 | signal |
| 32 | Squamous Cell Carcinoma | 4 | 9.0 | 9.1 | signal |
| 33 | Multi-organ Failure | 7 | 8.5 | 8.5 | signal |
| 34 | Drug Level Decreased | 4 | 8.3 | 8.4 | signal |
| 35 | Drug Resistance | 9 | 7.5 | 7.5 | signal |
| 36 | Diabetes Mellitus Inadequate Control | 6 | 7.2 | 7.3 | signal |
| 37 | Malignant Neoplasm Progression | 34 | 7.1 | 7.3 | signal |
| 38 | Osteonecrosis | 11 | 7.1 | 7.1 | signal |
| 39 | Schizophrenia | 4 | 7.0 | 7.0 | signal |
| 40 | Tooth Extraction | 4 | 6.8 | 6.9 | signal |
| 41 | Injection Site Induration | 4 | 6.6 | 6.6 | signal |
| 42 | Prescribed Underdose | 6 | 6.4 | 6.4 | signal |
| 43 | Pain Of Skin | 8 | 6.3 | 6.4 | signal |
| 44 | Tooth Loss | 5 | 5.1 | 5.1 | signal |
| 45 | Gynaecomastia | 7 | 4.8 | 4.8 | signal |
| 46 | Hepatocellular Injury | 3 | 4.5 | 4.5 | signal |
| 47 | Gastric Cancer | 5 | 4.2 | 4.2 | signal |
| 48 | Lung Neoplasm Malignant | 8 | 4.1 | 4.1 | signal |
| 49 | Extrapyramidal Disorder | 4 | 3.4 | 3.4 | signal |