PROTIONAMIDE: 498 Adverse Event Reports & Safety Profile
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498
Total FAERS Reports
113 (22.7%)
Deaths Reported
180
Hospitalizations
498
As Primary/Secondary Suspect
39
Life-Threatening
9
Disabilities
First Report: 19970502 · Latest Report: 20250321
What Are the Most Common PROTIONAMIDE Side Effects?
#1 Most Reported
Electrocardiogram qt prolonged
94 reports (18.9%)
#2 Most Reported
Hepatotoxicity
88 reports (17.7%)
#3 Most Reported
Vomiting
68 reports (13.7%)
All PROTIONAMIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Electrocardiogram qt prolonged | 94 | 18.9% | 10 | 22 |
| Hepatotoxicity | 88 | 17.7% | 2 | 19 |
| Vomiting | 68 | 13.7% | 25 | 43 |
| Neuropathy peripheral | 39 | 7.8% | 8 | 16 |
| Off label use | 39 | 7.8% | 7 | 14 |
| Anaemia | 36 | 7.2% | 6 | 14 |
| Drug resistance | 34 | 6.8% | 9 | 5 |
| Aspartate aminotransferase increased | 33 | 6.6% | 16 | 15 |
| Nausea | 33 | 6.6% | 8 | 15 |
| Alanine aminotransferase increased | 31 | 6.2% | 10 | 16 |
| Hypokalaemia | 25 | 5.0% | 8 | 16 |
| Treatment failure | 24 | 4.8% | 4 | 3 |
| Arthralgia | 21 | 4.2% | 5 | 3 |
| Drug-induced liver injury | 21 | 4.2% | 0 | 15 |
| Renal failure | 21 | 4.2% | 12 | 12 |
| Gastrointestinal disorder | 19 | 3.8% | 1 | 4 |
| Haemoglobin decreased | 19 | 3.8% | 11 | 7 |
| Pyrexia | 19 | 3.8% | 3 | 16 |
| Asthenia | 18 | 3.6% | 8 | 9 |
| Tuberculosis | 18 | 3.6% | 9 | 8 |
Who Reports PROTIONAMIDE Side Effects? Age & Gender Data
Gender: 39.1% female, 60.9% male. Average age: 40.5 years. Most reports from: CN. View detailed demographics →
Is PROTIONAMIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 4 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 3 | 0 | 3 |
| 2016 | 20 | 8 | 6 |
| 2017 | 58 | 15 | 29 |
| 2018 | 121 | 44 | 57 |
| 2019 | 81 | 8 | 20 |
| 2020 | 8 | 2 | 3 |
| 2021 | 3 | 0 | 1 |
| 2022 | 4 | 0 | 1 |
| 2023 | 2 | 0 | 2 |
| 2024 | 1 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is PROTIONAMIDE Used For?
| Indication | Reports |
|---|---|
| Tuberculosis | 369 |
| Pulmonary tuberculosis | 83 |
| Product used for unknown indication | 22 |
PROTIONAMIDE vs Alternatives: Which Is Safer?
PROTIONAMIDE vs PROTONIX
PROTIONAMIDE vs PROTOPIC
PROTIONAMIDE vs PROVENGE
PROTIONAMIDE vs PROVENTIL
PROTIONAMIDE vs PROVERA
PROTIONAMIDE vs PROZAC
PROTIONAMIDE vs PRUCALOPRIDE
PROTIONAMIDE vs PSEUDOEPHEDRINE
PROTIONAMIDE vs PSEUDOEPHEDRINE\TRIPROLIDINE
PROTIONAMIDE vs PSYLLIUM HUSK
Official FDA Label for PROTIONAMIDE
Official prescribing information from the FDA-approved drug label.