Drug
Doxylamine Succinate And Pyridoxine Hydrochloride
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 | Premature Delivery | 47 | 118.4 | 130.0 | signal |
| 2 | Exposure During Pregnancy | 45 | 29.1 | 31.7 | signal |
| 3 | Maternal Exposure During Pregnancy | 61 | 27.8 | 31.3 | signal |
| 4 | Caesarean Section | 8 | 27.3 | 27.8 | signal |
| 5 | Abortion Spontaneous | 25 | 25.0 | 26.2 | signal |
| 6 | Rebound Effect | 6 | 21.3 | 21.5 | signal |
| 7 | Serotonin Syndrome | 10 | 21.0 | 21.4 | signal |
| 8 | Foetal Exposure During Pregnancy | 39 | 19.3 | 20.8 | signal |
| 9 | Pregnancy | 9 | 17.9 | 18.2 | signal |
| 10 | Pharyngeal Swelling | 4 | 16.8 | 16.9 | signal |
| 11 | Akathisia | 5 | 14.7 | 14.9 | signal |
| 12 | Premature Baby | 10 | 13.3 | 13.5 | signal |
| 13 | Muscle Spasticity | 3 | 9.7 | 9.8 | signal |
| 14 | Drug Withdrawal Syndrome Neonatal | 3 | 8.1 | 8.1 | signal |
| 15 | Drug Dispensing Error | 3 | 7.8 | 7.8 | signal |
| 16 | Vaginal Haemorrhage | 7 | 6.6 | 6.7 | signal |
| 17 | Drug Dependence | 10 | 2.5 | 2.5 | signal |