Drug
Betaine
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 | Gastroenteritis Viral | 29 | 32.5 | 33.4 | signal |
| 2 | Brain Oedema | 18 | 28.9 | 29.4 | signal |
| 3 | Product Odour Abnormal | 10 | 19.5 | 19.7 | signal |
| 4 | Pharyngitis Streptococcal | 10 | 18.7 | 18.9 | signal |
| 5 | Prescribed Overdose | 17 | 17.8 | 18.1 | signal |
| 6 | Product Dose Omission | 55 | 16.9 | 17.7 | signal |
| 7 | Therapy Change | 7 | 14.7 | 14.8 | signal |
| 8 | Gastroenteritis | 10 | 13.9 | 14.1 | signal |
| 9 | Treatment Noncompliance | 30 | 11.2 | 11.5 | signal |
| 10 | Disseminated Intravascular Coagulation | 7 | 10.1 | 10.1 | signal |
| 11 | Poor Quality Product Administered | 5 | 9.9 | 10.0 | signal |
| 12 | Cholestasis | 9 | 9.6 | 9.6 | signal |
| 13 | Product Taste Abnormal | 6 | 9.1 | 9.1 | signal |
| 14 | Hepatic Encephalopathy | 4 | 8.7 | 8.7 | signal |
| 15 | Hepatocellular Injury | 6 | 8.6 | 8.6 | signal |
| 16 | Overdose | 86 | 8.1 | 8.7 | signal |
| 17 | Inappropriate Schedule Of Drug Administration | 26 | 7.3 | 7.5 | signal |
| 18 | Wrist Fracture | 4 | 6.8 | 6.8 | signal |
| 19 | Underdose | 22 | 6.1 | 6.2 | signal |
| 20 | Acute Hepatic Failure | 4 | 6.0 | 6.0 | signal |
| 21 | Abortion Spontaneous | 8 | 4.0 | 4.1 | signal |
| 22 | Drug Dose Omission | 23 | 2.8 | 2.8 | signal |