ORNIDAZOLE: 121 Adverse Event Reports & Safety Profile
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121
Total FAERS Reports
12 (9.9%)
Deaths Reported
70
Hospitalizations
121
As Primary/Secondary Suspect
19
Life-Threatening
13
Disabilities
First Report: 19951001 · Latest Report: 20250511
What Are the Most Common ORNIDAZOLE Side Effects?
#1 Most Reported
Premature baby
17 reports (14.0%)
#2 Most Reported
Maternal exposure during pregnancy
13 reports (10.7%)
#3 Most Reported
Foetal exposure during pregnancy
12 reports (9.9%)
All ORNIDAZOLE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Premature baby | 17 | 14.1% | 3 | 12 |
| Maternal exposure during pregnancy | 13 | 10.7% | 0 | 8 |
| Foetal exposure during pregnancy | 12 | 9.9% | 3 | 8 |
| Foetal growth restriction | 11 | 9.1% | 0 | 11 |
| Acute kidney injury | 10 | 8.3% | 0 | 10 |
| Oligohydramnios | 10 | 8.3% | 0 | 10 |
| Overdose | 8 | 6.6% | 4 | 0 |
| Rash | 7 | 5.8% | 0 | 6 |
| Nausea | 6 | 5.0% | 0 | 2 |
| Premature delivery | 6 | 5.0% | 0 | 1 |
| Suicide attempt | 6 | 5.0% | 0 | 1 |
| Diverticulitis | 5 | 4.1% | 0 | 5 |
| Hypotension | 5 | 4.1% | 0 | 4 |
| Low birth weight baby | 5 | 4.1% | 2 | 3 |
| No adverse event | 5 | 4.1% | 0 | 4 |
Who Reports ORNIDAZOLE Side Effects? Age & Gender Data
Gender: 63.7% female, 36.3% male. Average age: 49.7 years. Most reports from: CN. View detailed demographics →
Is ORNIDAZOLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 2 | 0 | 2 |
| 2012 | 2 | 2 | 2 |
| 2013 | 3 | 0 | 1 |
| 2015 | 2 | 0 | 0 |
| 2016 | 2 | 0 | 1 |
| 2017 | 3 | 0 | 3 |
| 2018 | 27 | 0 | 25 |
| 2019 | 4 | 0 | 1 |
| 2020 | 6 | 0 | 5 |
| 2021 | 7 | 0 | 3 |
| 2022 | 3 | 0 | 2 |
| 2023 | 11 | 0 | 10 |
| 2024 | 2 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is ORNIDAZOLE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 34 |
| Infection | 13 |
| Meningitis | 9 |
| Anti-infective therapy | 7 |
ORNIDAZOLE vs Alternatives: Which Is Safer?
ORNIDAZOLE vs ORPHENADRINE
ORNIDAZOLE vs OSELTAMIVIR
ORNIDAZOLE vs OSILODROSTAT
ORNIDAZOLE vs OSIMERTINIB
ORNIDAZOLE vs OSPEMIFENE
ORNIDAZOLE vs OSPHENA
ORNIDAZOLE vs OVINE DIGOXIN IMMUNE FAB
ORNIDAZOLE vs OXACILLIN
ORNIDAZOLE vs OXALIPLATIN
ORNIDAZOLE vs OXAPROZIN
Official FDA Label for ORNIDAZOLE
Official prescribing information from the FDA-approved drug label.