THIAMINE MONONITRATE: 54 Adverse Event Reports & Safety Profile
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54
Total FAERS Reports
0
Deaths Reported
2
Hospitalizations
54
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 19961204 · Latest Report: 20250323
What Are the Most Common THIAMINE MONONITRATE Side Effects?
#1 Most Reported
Hypersensitivity
22 reports (40.7%)
#2 Most Reported
Vitamin b12 deficiency
19 reports (35.2%)
#3 Most Reported
Regurgitation
19 reports (35.2%)
All THIAMINE MONONITRATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypersensitivity | 22 | 40.7% | 0 | 0 |
| Abdominal distension | 19 | 35.2% | 0 | 0 |
| Barrett's oesophagus | 19 | 35.2% | 0 | 0 |
| Dyspepsia | 19 | 35.2% | 0 | 0 |
| Eructation | 19 | 35.2% | 0 | 0 |
| Neck pain | 19 | 35.2% | 0 | 0 |
| Oropharyngeal discomfort | 19 | 35.2% | 0 | 0 |
| Regurgitation | 19 | 35.2% | 0 | 0 |
| Vitamin b12 deficiency | 19 | 35.2% | 0 | 0 |
| Off label use | 18 | 33.3% | 0 | 0 |
| Drug hypersensitivity | 17 | 31.5% | 0 | 0 |
| Toxic epidermal necrolysis | 17 | 31.5% | 0 | 0 |
| Product use in unapproved indication | 15 | 27.8% | 0 | 0 |
| Foetal exposure during pregnancy | 6 | 11.1% | 0 | 0 |
| Multiple congenital abnormalities | 6 | 11.1% | 0 | 0 |
| Premature baby | 6 | 11.1% | 0 | 0 |
| Pulmonary valve stenosis | 6 | 11.1% | 0 | 0 |
| Scrotal disorder | 6 | 11.1% | 0 | 0 |
Who Reports THIAMINE MONONITRATE Side Effects? Age & Gender Data
Gender: 6.0% female, 94.0% male. Average age: 51.4 years. Most reports from: GB. View detailed demographics →
Is THIAMINE MONONITRATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 17 | 0 | 0 |
| 2020 | 22 | 0 | 0 |
| 2025 | 1 | 0 | 0 |
What Is THIAMINE MONONITRATE Used For?
| Indication | Reports |
|---|---|
| Hypovitaminosis | 23 |
| Pneumonia | 13 |
| Ill-defined disorder | 12 |
| Product used for unknown indication | 11 |
| Nutritional supplementation | 5 |
Official FDA Label for THIAMINE MONONITRATE
Official prescribing information from the FDA-approved drug label.