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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TOLBUTAMIDE: 33 Adverse Event Reports & Safety Profile

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33
Total FAERS Reports
1 (3.0%)
Deaths Reported
20
Hospitalizations
33
As Primary/Secondary Suspect
7
Life-Threatening
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 010670 ·

First Report: 2007 · Latest Report: 20161120

What Are the Most Common TOLBUTAMIDE Side Effects?

#1 Most Reported
Renal failure acute
10 reports (30.3%)
#2 Most Reported
International normalised ratio increased
10 reports (30.3%)
#3 Most Reported
Hypoglycaemia
10 reports (30.3%)

All TOLBUTAMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Epistaxis 10 30.3% 0 10
Hypoglycaemia 10 30.3% 0 10
International normalised ratio increased 10 30.3% 0 10
Renal failure acute 10 30.3% 0 10
Fatigue 8 24.2% 0 7
Blood glucose increased 7 21.2% 0 7
Crying 7 21.2% 0 7
Feeling cold 7 21.2% 0 7
Hypersomnia 7 21.2% 0 7
Injection site pruritus 7 21.2% 0 7
Liver disorder 7 21.2% 0 7
Nausea 7 21.2% 0 7
Suicidal ideation 7 21.2% 0 7
Thinking abnormal 7 21.2% 0 7
Hyponatraemia 6 18.2% 0 0
Delirium 5 15.2% 0 0

Who Reports TOLBUTAMIDE Side Effects? Age & Gender Data

Gender: 81.0% female, 19.0% male. Average age: 74.4 years. Most reports from: NL. View detailed demographics →

Is TOLBUTAMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 1 1
2013 7 0 7
2015 1 0 0
2016 1 0 1

View full timeline →

What Is TOLBUTAMIDE Used For?

IndicationReports
Type 2 diabetes mellitus 16
Product used for unknown indication 11

Official FDA Label for TOLBUTAMIDE

Official prescribing information from the FDA-approved drug label.