PHENYLBUTAZONE: 60 Adverse Event Reports & Safety Profile
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60
Total FAERS Reports
2 (3.3%)
Deaths Reported
9
Hospitalizations
60
As Primary/Secondary Suspect
2
Life-Threatening
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 008319 ·
First Report: 1981 · Latest Report: 20230104
What Are the Most Common PHENYLBUTAZONE Side Effects?
#1 Most Reported
Hypersensitivity
25 reports (41.7%)
#2 Most Reported
Vitamin b12 deficiency
21 reports (35.0%)
#3 Most Reported
Regurgitation
21 reports (35.0%)
All PHENYLBUTAZONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypersensitivity | 25 | 41.7% | 0 | 0 |
| Abdominal distension | 21 | 35.0% | 0 | 0 |
| Barrett's oesophagus | 21 | 35.0% | 0 | 0 |
| Dyspepsia | 21 | 35.0% | 0 | 0 |
| Eructation | 21 | 35.0% | 0 | 0 |
| Neck pain | 21 | 35.0% | 0 | 0 |
| Oropharyngeal discomfort | 21 | 35.0% | 0 | 0 |
| Regurgitation | 21 | 35.0% | 0 | 0 |
| Vitamin b12 deficiency | 21 | 35.0% | 0 | 0 |
| Drug hypersensitivity | 9 | 15.0% | 0 | 0 |
| Peptic ulcer | 7 | 11.7% | 0 | 0 |
| Renal impairment | 7 | 11.7% | 0 | 0 |
| Secondary adrenocortical insufficiency | 6 | 10.0% | 0 | 0 |
Who Reports PHENYLBUTAZONE Side Effects? Age & Gender Data
Gender: 10.1% female, 89.9% male. Average age: 52.5 years. Most reports from: GB. View detailed demographics →
Is PHENYLBUTAZONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 25 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 2 | 0 | 2 |
What Is PHENYLBUTAZONE Used For?
| Indication | Reports |
|---|---|
| Hypovitaminosis | 24 |
| Product used for unknown indication | 13 |
Official FDA Label for PHENYLBUTAZONE
Official prescribing information from the FDA-approved drug label.