Drug
Leuprolide
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 | 26 | 26.6 | 27.1 | signal |
| 2 | Pneumocystis Jirovecii Pneumonia | 16 | 22.7 | 22.9 | signal |
| 3 | Metastases To Bone | 26 | 22.5 | 22.9 | signal |
| 4 | Respiratory Depression | 17 | 19.6 | 19.9 | signal |
| 5 | Breast Cancer Metastatic | 13 | 17.2 | 17.3 | signal |
| 6 | Hypomagnesaemia | 12 | 12.2 | 12.3 | signal |
| 7 | Tenderness | 8 | 10.8 | 10.9 | signal |
| 8 | Transfusion | 8 | 10.8 | 10.8 | signal |
| 9 | Obesity | 12 | 10.6 | 10.7 | signal |
| 10 | Metastases To Liver | 13 | 10.5 | 10.6 | signal |
| 11 | Febrile Neutropenia | 48 | 10.3 | 10.6 | signal |
| 12 | Product Prescribing Error | 16 | 9.6 | 9.7 | signal |
| 13 | Malignant Neoplasm Progression | 56 | 7.8 | 8.0 | signal |
| 14 | Therapy Partial Responder | 8 | 7.5 | 7.6 | signal |
| 15 | Product Storage Error | 45 | 7.4 | 7.6 | signal |
| 16 | Metastases To Lung | 6 | 7.4 | 7.4 | signal |
| 17 | Hot Flush | 37 | 6.9 | 7.1 | signal |
| 18 | Brain Fog | 7 | 6.8 | 6.8 | signal |
| 19 | Disease Progression | 56 | 6.7 | 6.9 | signal |
| 20 | Nephropathy Toxic | 5 | 6.4 | 6.4 | signal |
| 21 | Myocardial Ischaemia | 5 | 6.2 | 6.2 | signal |
| 22 | Treatment Failure | 34 | 5.9 | 6.0 | signal |
| 23 | Rhabdomyolysis | 17 | 5.8 | 5.8 | signal |
| 24 | Osteonecrosis Of Jaw | 10 | 5.7 | 5.7 | signal |
| 25 | Metastases To Central Nervous System | 5 | 5.5 | 5.5 | signal |
| 26 | Erectile Dysfunction | 10 | 5.5 | 5.5 | signal |
| 27 | Cytokine Release Syndrome | 7 | 5.2 | 5.2 | signal |
| 28 | Abortion Spontaneous | 14 | 4.9 | 5.0 | signal |
| 29 | Madarosis | 4 | 4.8 | 4.8 | signal |
| 30 | Acute Myeloid Leukaemia | 5 | 4.5 | 4.6 | signal |
| 31 | Drug Resistance | 8 | 4.4 | 4.4 | signal |
| 32 | Decreased Immune Responsiveness | 3 | 4.3 | 4.4 | signal |
| 33 | Injection Site Urticaria | 7 | 4.1 | 4.1 | signal |
| 34 | Pelvic Pain | 5 | 3.9 | 3.9 | signal |
| 35 | Injection Site Mass | 10 | 3.8 | 3.9 | signal |
| 36 | Premature Delivery | 4 | 3.5 | 3.5 | signal |
| 37 | Hepatic Cytolysis | 3 | 3.5 | 3.5 | no signal |
| 38 | Needle Issue | 7 | 3.5 | 3.5 | signal |
| 39 | Hair Colour Changes | 3 | 3.4 | 3.4 | no signal |
| 40 | Injection Site Irritation | 3 | 3.4 | 3.4 | no signal |
| 41 | Complication Associated With Device | 3 | 3.2 | 3.2 | no signal |
| 42 | Hair Texture Abnormal | 3 | 3.1 | 3.2 | no signal |
| 43 | Diabetic Ketoacidosis | 5 | 3.0 | 3.0 | signal |
| 44 | Neoplasm Progression | 7 | 2.8 | 2.8 | signal |
| 45 | Prostate Cancer | 16 | 2.8 | 2.8 | signal |
| 46 | Drug Abuse | 14 | 2.4 | 2.4 | signal |
| 47 | Injection Site Rash | 5 | 2.3 | 2.3 | no signal |
| 48 | Injection Site Pruritus | 9 | 1.9 | 1.9 | no signal |
| 49 | Gynaecomastia | 4 | 1.8 | 1.8 | no signal |
| 50 | Injection Site Erythema | 14 | 1.6 | 1.6 | no signal |
| 51 | Drug Dependence | 18 | 1.6 | 1.6 | no signal |
| 52 | Injection Site Haemorrhage | 7 | 1.2 | 1.2 | no signal |