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Tolbutamide Side Effects

The most commonly reported side effects of tolbutamide include fatigue, drug interaction, and arthralgia, based on 483 FDA adverse event reports from 2004 to 2025. 4.8% of reports found the drug to be ineffective.

Tolbutamide side effects

Percentages show how often each reaction appears relative to total reports for tolbutamide.

1
Fatigue5.2%25
2
Drug Ineffective4.8%23
3
Drug Interaction4.3%21
4
Arthralgia4.1%20
5
Death3.9%19
6
Pain3.9%19
7
Malaise3.9%19
8
Blood Pressure Increased3.7%18
9
Dyspnoea3.5%17
10
Blood Pressure Diastolic Decreased3.5%17
11
Nasopharyngitis3.5%17
12
Hypersomnia3.5%17
13
Dizziness3.3%16
14
Fall3.1%15
15
Depressed Mood2.9%14

These are voluntary reports and do not establish that tolbutamide caused these reactions.

Report severity

93.0%Serious449 reports
50.5%Hospitalizations244 reports
16.4%Fatal79 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tolbutamide drug interactions

Other drugs that appear in adverse event reports alongside tolbutamide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Metformin7.0%34
2
Spironolactone3.7%18
3
Lisinopril3.7%18
4
Metoprolol3.5%17
5
Digoxin3.1%15
6
Bumetanide2.9%14
7
Simvastatin2.7%13
8
Enalapril-maleate2.7%13
9
Liraglutide2.7%13
10
Rituximab2.7%13
11
Methotrexate2.7%13
12
Furosemide2.5%12
13
Atorvastatin-calcium2.5%12
14
Warfarin2.3%11
15
Pioglitazone-hydrochloride2.3%11

Taken alongside

1
Metformin41.4%200
2
Simvastatin21.5%104
3
Aspirin16.6%80
4
Acetaminophen14.9%72
5
Amlodipine13.0%63
6
Omeprazole13.0%63
7
Hydrochlorothiazide12.8%62
8
Metoprolol11.8%57
9
Insulin10.6%51
10
Furosemide10.4%50
11
Atorvastatin-calcium9.9%48
12
Lisinopril9.5%46
13
Pantoprazole-sodium8.9%43
14
Calcium8.1%39
15
Enalapril-maleate7.0%34

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports tolbutamide side effects

44.5% of tolbutamide adverse event reports involve female patients and 47.6% involve male patients. The largest age group is elderly at 65%. These figures reflect who reports side effects, not underlying risk.

Sex

Female44.5%
Male47.6%
Unknown7.9%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6434.8%
65+65.2%

What is tolbutamide used for

Conditions and purposes for which patients were taking tolbutamide when the adverse event was reported.

Blood Glucose IncreasedDiabetes MellitusDiabetes Mellitus Non-insulin-dependentDrug Use For Unknown IndicationEmphysemaFluid RetentionHyperglycaemiaHypertensionIll-defined DisorderIll-defined DisorderKidney AblationNephrectomyProduct Used For Unknown IndicationProduct Used For Unknown IndicationRenal Disorder

Showing 15 of 17 indications

Tolbutamide brand names and reporting trend

Tolbutamide is sold under brand names including Orinase, Orinase Diagnostic.

Brand names

Orinase460
Orinase Diagnostic32

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking tolbutamide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.