Drug
Nirogacestat
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 | Product Dose Omission In Error | 42 | 39.2 | 41.2 | signal |
| 2 | Amenorrhoea | 17 | 25.5 | 26.0 | signal |
| 3 | Dry Throat | 10 | 24.7 | 25.0 | signal |
| 4 | Stomatitis | 59 | 24.4 | 26.1 | signal |
| 5 | Folliculitis | 8 | 19.4 | 19.6 | signal |
| 6 | Intentional Dose Omission | 19 | 17.4 | 17.8 | signal |
| 7 | Brain Fog | 10 | 17.2 | 17.4 | signal |
| 8 | Insurance Issue | 9 | 15.2 | 15.3 | signal |
| 9 | Thirst | 10 | 14.0 | 14.2 | signal |
| 10 | Epistaxis | 37 | 12.4 | 12.9 | signal |
| 11 | Neoplasm Progression | 17 | 12.1 | 12.4 | signal |
| 12 | Cyst | 6 | 12.1 | 12.2 | signal |
| 13 | Hot Flush | 35 | 11.6 | 12.1 | signal |
| 14 | Ocular Discomfort | 5 | 11.5 | 11.6 | signal |
| 15 | Rash Maculo-papular | 10 | 11.3 | 11.4 | signal |
| 16 | Intestinal Perforation | 5 | 11.1 | 11.2 | signal |
| 17 | Impaired Driving Ability | 5 | 11.0 | 11.1 | signal |
| 18 | Skin Cancer | 9 | 10.5 | 10.6 | signal |
| 19 | Vitreous Floaters | 4 | 10.3 | 10.3 | signal |
| 20 | Menstruation Delayed | 4 | 9.6 | 9.7 | signal |
| 21 | Pharyngitis Streptococcal | 4 | 9.2 | 9.3 | signal |
| 22 | Therapy Cessation | 16 | 7.8 | 8.0 | signal |
| 23 | Underdose | 20 | 6.9 | 7.0 | signal |
| 24 | Cytokine Release Syndrome | 5 | 6.6 | 6.6 | signal |
| 25 | Peritonitis | 5 | 6.0 | 6.1 | signal |
| 26 | Hair Texture Abnormal | 3 | 5.6 | 5.6 | signal |
| 27 | Skin Irritation | 8 | 4.4 | 4.4 | signal |
| 28 | Menstruation Irregular | 4 | 3.8 | 3.8 | signal |