ISONIAZID\PYRIDOXINE: 73 Adverse Event Reports & Safety Profile
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73
Total FAERS Reports
1 (1.4%)
Deaths Reported
55
Hospitalizations
73
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities
Active Ingredient: ISONIAZID\PYRIDOXINE HYDROCHLORIDE ·
First Report: 1970 · Latest Report: 20250723
What Are the Most Common ISONIAZID\PYRIDOXINE Side Effects?
#1 Most Reported
Anaemia
28 reports (38.4%)
#2 Most Reported
Pyrexia
22 reports (30.1%)
#3 Most Reported
Headache
22 reports (30.1%)
All ISONIAZID\PYRIDOXINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 28 | 38.4% | 0 | 28 |
| Headache | 22 | 30.1% | 0 | 21 |
| Pyrexia | 22 | 30.1% | 0 | 20 |
| Abdominal pain | 20 | 27.4% | 0 | 20 |
| Drug ineffective | 20 | 27.4% | 0 | 20 |
| Macular degeneration | 20 | 27.4% | 0 | 20 |
| Nausea | 20 | 27.4% | 0 | 19 |
| Off label use | 20 | 27.4% | 0 | 20 |
| Pain | 20 | 27.4% | 0 | 19 |
| Chronic sinusitis | 19 | 26.0% | 0 | 19 |
| Erythema | 19 | 26.0% | 0 | 18 |
| Malaise | 19 | 26.0% | 0 | 19 |
| Paraesthesia oral | 19 | 26.0% | 0 | 19 |
| Therapeutic product effect incomplete | 19 | 26.0% | 0 | 19 |
| Weight decreased | 19 | 26.0% | 0 | 19 |
| Colitis | 18 | 24.7% | 0 | 18 |
| Constipation | 18 | 24.7% | 0 | 18 |
| Female genital tract fistula | 18 | 24.7% | 0 | 18 |
| Frequent bowel movements | 18 | 24.7% | 0 | 18 |
| Haematochezia | 18 | 24.7% | 0 | 18 |
Who Reports ISONIAZID\PYRIDOXINE Side Effects? Age & Gender Data
Gender: 47.9% female, 52.1% male. Average age: 54.3 years. Most reports from: ES. View detailed demographics →
Is ISONIAZID\PYRIDOXINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2017 | 3 | 0 | 1 |
| 2018 | 2 | 0 | 2 |
| 2019 | 13 | 0 | 11 |
| 2020 | 3 | 0 | 0 |
| 2021 | 3 | 0 | 3 |
| 2023 | 8 | 0 | 6 |
| 2025 | 2 | 0 | 2 |
What Is ISONIAZID\PYRIDOXINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 25 |
| Tuberculosis | 16 |
| Pulmonary tuberculosis | 9 |
| Latent tuberculosis | 7 |
Official FDA Label for ISONIAZID\PYRIDOXINE
Official prescribing information from the FDA-approved drug label.