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acarbose Side Effects

Also known as: Precose

Analysis of 3,736 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

3,736

Death-Related

310

8.3% of reports

Hospitalizations

2,037

54.5% of reports

Top Indication

Diabetes Mellitus

Most Reported Adverse Reactions

HYPOGLYCAEMIA
269
NAUSEA
203
BLOOD GLUCOSE INCREASED
200
DIZZINESS
160
DIARRHOEA
147
DRUG INTERACTION
142
VOMITING
142
ACUTE KIDNEY INJURY
139
DRUG INEFFECTIVE
134
OFF LABEL USE
131
FALL
125
ASTHENIA
112
LACTIC ACIDOSIS
107
DYSPNOEA
103
DIABETES MELLITUS INADEQUATE CONTROL
99
PNEUMONIA
99
WEIGHT DECREASED
94
PRURITUS
93
FATIGUE
87
PYREXIA
86

Who Reports Side Effects

Gender Distribution

Female 1,793 (51%)
Male 1,726 (49%)
Unknown 4

Age Distribution

0-17 48 (2%)
18-44 233 (8%)
45-64 949 (33%)
65-74 864 (30%)
75+ 784 (27%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 310 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 45
CARDIAC ARREST 35
ACUTE KIDNEY INJURY 34
PNEUMONIA 30
LACTIC ACIDOSIS 28
DYSPNOEA 22
VOMITING 20
COMPLETED SUICIDE 19
METABOLIC ACIDOSIS 17
TACHYCARDIA 17
HAEMODYNAMIC INSTABILITY 15
HYPERKALAEMIA 15
RESPIRATORY FAILURE 15
ASTHENIA 14
CARDIO-RESPIRATORY ARREST 14
CARDIOGENIC SHOCK 14
CEREBROVASCULAR ACCIDENT 14
DEHYDRATION 14
FALL 14
UNRESPONSIVE TO STIMULI 14

Reactions in Hospitalization Reports

Top reactions in 2,037 reports where hospitalization was an outcome.

Reaction Reports
HYPOGLYCAEMIA 186
BLOOD GLUCOSE INCREASED 117
NAUSEA 117
FALL 104
VOMITING 93
ACUTE KIDNEY INJURY 91
DIZZINESS 91
DRUG INTERACTION 87
LACTIC ACIDOSIS 87
DIARRHOEA 81
PNEUMONIA 81
ASTHENIA 75
DYSPNOEA 69
DIABETES MELLITUS INADEQUATE CONTROL 67
PYREXIA 65
CONSTIPATION 61
HYPERKALAEMIA 60
HYPERTENSION 60
HYPOTENSION 56
DECREASED APPETITE 54

Nearby — Related Medications

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What the FAERS Data Reveals About acarbose Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 3,736 voluntary reports linked to acarbose and its brand equivalents (Precose), spanning 2004 through 2025. Of those, 310 (8.3%) listed death as an outcome and 2,037 (54.5%) involved hospitalization. The most common indication reported alongside adverse events was Diabetes Mellitus.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 49% male; age distribution skews toward 45-64, with 949 reports in that bracket. The single most reported reaction is hypoglycaemia with 269 submissions, followed by nausea and blood glucose increased.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.