Drug
Follitropin Alfa
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 | Ascites | 223 | 79.7 | 89.6 | signal |
| 2 | Abortion Spontaneous | 123 | 32.0 | 34.0 | signal |
| 3 | Ovarian Cyst | 25 | 26.0 | 26.3 | signal |
| 4 | Caesarean Section | 27 | 24.0 | 24.3 | signal |
| 5 | Drug Exposure During Pregnancy | 58 | 17.6 | 18.1 | signal |
| 6 | Pregnancy | 34 | 17.6 | 17.9 | signal |
| 7 | Pleural Effusion | 76 | 13.0 | 13.5 | signal |
| 8 | Drug Level Decreased | 12 | 12.3 | 12.3 | signal |
| 9 | Abdominal Pain Lower | 29 | 11.9 | 12.1 | signal |
| 10 | Abdominal Distension | 116 | 11.7 | 12.3 | signal |
| 11 | Inappropriate Schedule Of Drug Administration | 80 | 11.6 | 12.0 | signal |
| 12 | Pelvic Pain | 17 | 9.8 | 9.8 | signal |
| 13 | Premature Baby | 24 | 8.3 | 8.4 | signal |
| 14 | Generalised Tonic-clonic Seizure | 11 | 7.0 | 7.1 | signal |
| 15 | Maternal Exposure During Pregnancy | 50 | 5.9 | 6.0 | signal |
| 16 | Vaginal Haemorrhage | 23 | 5.6 | 5.7 | signal |
| 17 | Abortion Induced | 5 | 5.5 | 5.5 | signal |
| 18 | Post Procedural Haemorrhage | 6 | 5.4 | 5.4 | signal |
| 19 | Premature Delivery | 8 | 5.2 | 5.2 | signal |
| 20 | Hepatocellular Injury | 7 | 5.1 | 5.2 | signal |
| 21 | Breast Pain | 5 | 4.9 | 4.9 | signal |
| 22 | Adverse Reaction | 6 | 4.7 | 4.7 | signal |
| 23 | Ovarian Cancer | 4 | 4.5 | 4.5 | signal |
| 24 | Cardiovascular Disorder | 11 | 4.5 | 4.5 | signal |
| 25 | Exposure During Pregnancy | 23 | 3.9 | 3.9 | signal |
| 26 | Foetal Exposure During Pregnancy | 27 | 3.5 | 3.5 | signal |
| 27 | Needle Issue | 9 | 3.3 | 3.3 | signal |
| 28 | Vaginal Discharge | 3 | 3.1 | 3.1 | no signal |
| 29 | Mood Altered | 8 | 3.1 | 3.1 | signal |
| 30 | Injection Site Discomfort | 3 | 3.0 | 3.0 | no signal |
| 31 | Ischaemic Stroke | 5 | 2.9 | 2.9 | signal |
| 32 | Dysmenorrhoea | 3 | 2.4 | 2.4 | no signal |
| 33 | Injection Site Haematoma | 3 | 2.1 | 2.1 | no signal |
| 34 | Menorrhagia | 4 | 2.1 | 2.1 | no signal |
| 35 | Injury Associated With Device | 4 | 2.1 | 2.1 | no signal |
| 36 | Breast Cancer Female | 5 | 1.9 | 1.9 | no signal |
| 37 | Injection Site Bruising | 14 | 1.9 | 1.9 | no signal |
| 38 | Injection Site Erythema | 15 | 1.3 | 1.3 | no signal |
| 39 | Breast Cancer | 10 | 1.1 | 1.1 | no signal |
| 40 | Injection Site Pruritus | 7 | 1.1 | 1.1 | no signal |
| 41 | Injection Site Haemorrhage | 8 | 1.1 | 1.1 | no signal |
| 42 | Gynaecomastia | 3 | 1.0 | 1.0 | no signal |