SULFAMETHIZOLE: 60 Adverse Event Reports & Safety Profile
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60
Total FAERS Reports
4 (6.7%)
Deaths Reported
44
Hospitalizations
60
As Primary/Secondary Suspect
4
Life-Threatening
20
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 008565 ·
First Report: 2009 · Latest Report: 20211001
What Are the Most Common SULFAMETHIZOLE Side Effects?
#1 Most Reported
Pyrexia
45 reports (75.0%)
#2 Most Reported
Sinusitis
42 reports (70.0%)
#3 Most Reported
Fatigue
42 reports (70.0%)
All SULFAMETHIZOLE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pyrexia | 45 | 75.0% | 1 | 37 |
| Arthralgia | 42 | 70.0% | 1 | 34 |
| Dyspnoea | 42 | 70.0% | 1 | 34 |
| Fatigue | 42 | 70.0% | 1 | 34 |
| Sinusitis | 42 | 70.0% | 1 | 34 |
| Pain | 27 | 45.0% | 1 | 19 |
| Drug ineffective | 26 | 43.3% | 1 | 18 |
| Sleep disorder | 25 | 41.7% | 1 | 17 |
| Swelling | 25 | 41.7% | 1 | 16 |
| Blister | 24 | 40.0% | 1 | 16 |
| Confusional state | 24 | 40.0% | 1 | 16 |
| Contraindicated product administered | 24 | 40.0% | 1 | 16 |
| Drug hypersensitivity | 24 | 40.0% | 1 | 19 |
| Folliculitis | 24 | 40.0% | 1 | 16 |
| Gastrointestinal disorder | 24 | 40.0% | 1 | 16 |
| Hypersensitivity | 24 | 40.0% | 1 | 16 |
| Impaired healing | 24 | 40.0% | 1 | 16 |
| Irritable bowel syndrome | 24 | 40.0% | 1 | 16 |
| Joint swelling | 24 | 40.0% | 1 | 16 |
| Lower respiratory tract infection | 24 | 40.0% | 1 | 16 |
Who Reports SULFAMETHIZOLE Side Effects? Age & Gender Data
Gender: 98.2% female, 1.8% male. Average age: 52.1 years. Most reports from: CA. View detailed demographics →
Is SULFAMETHIZOLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 2 | 0 | 2 |
| 2015 | 3 | 0 | 3 |
| 2018 | 3 | 0 | 3 |
| 2021 | 1 | 0 | 0 |
What Is SULFAMETHIZOLE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 46 |
Official FDA Label for SULFAMETHIZOLE
Official prescribing information from the FDA-approved drug label.