CEFOTIAM: 60 Adverse Event Reports & Safety Profile
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60
Total FAERS Reports
12 (20.0%)
Deaths Reported
31
Hospitalizations
60
As Primary/Secondary Suspect
5
Life-Threatening
Dec 30, 1988
FDA Approved
Discontinued
Status
Active Ingredient: CEFOTIAM HYDROCHLORIDE · FDA Application: 050601 ·
First Report: 19941006 · Latest Report: 20211224
What Are the Most Common CEFOTIAM Side Effects?
#1 Most Reported
Toxic epidermal necrolysis
15 reports (25.0%)
#2 Most Reported
Pyrexia
13 reports (21.7%)
#3 Most Reported
Erythema
10 reports (16.7%)
All CEFOTIAM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxic epidermal necrolysis | 15 | 25.0% | 6 | 10 |
| Pyrexia | 13 | 21.7% | 3 | 9 |
| Erythema | 10 | 16.7% | 3 | 7 |
| Blister | 8 | 13.3% | 0 | 4 |
| Rash | 7 | 11.7% | 3 | 6 |
| Stevens-johnson syndrome | 7 | 11.7% | 0 | 3 |
| Petechiae | 6 | 10.0% | 0 | 3 |
| Rash macular | 6 | 10.0% | 0 | 3 |
| Drug-induced liver injury | 5 | 8.3% | 2 | 3 |
| Hysterectomy | 5 | 8.3% | 0 | 2 |
Who Reports CEFOTIAM Side Effects? Age & Gender Data
Gender: 49.2% female, 50.8% male. Average age: 60.5 years. Most reports from: JP. View detailed demographics →
Is CEFOTIAM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 7 | 0 | 4 |
| 2009 | 1 | 0 | 1 |
| 2011 | 1 | 1 | 1 |
| 2013 | 2 | 2 | 1 |
| 2014 | 5 | 0 | 4 |
| 2015 | 5 | 0 | 3 |
| 2016 | 2 | 0 | 1 |
| 2018 | 3 | 0 | 0 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
| 2021 | 3 | 0 | 2 |
What Is CEFOTIAM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Infection prophylaxis | 5 |
| Pneumonia | 5 |
Official FDA Label for CEFOTIAM
Official prescribing information from the FDA-approved drug label.