What the label lists and what reports show
Acarbose side effects
Acarbose's FDA label: “Digestive Tract Gastrointestinal symptoms are the most common reactions to Acarbose Tablets.” FAERS holds 3,847 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypoglycaemia (275 reports).
- Generic listed
Check it at the source: the acarbose FDA label on DailyMed (effective July 15, 2026, Strides Pharma Science Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsDigestive Tract Gastrointestinal symptoms are the most common reactions to Acarbose Tablets.
From the label: adverse reactions, continuedDigestive Tract Gastrointestinal symptoms are the most common reactions to Acarbose Tablets. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31%, and 74% respectively in 1255 patients treated with Acarbose Tablets 50-300 mg t.i.d., whereas the corresponding incidences were 9%, 12%, and 29% in 999 placebo-treated patients. In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with Acarbose Tablets are a manifestation of the mechanism of action of Acarbose Tablets and are related to the presence of undigested carbohydrate in the lower GI tract. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced. Elevated Serum Transaminase Levels See PRECAUTIONS . Other Abnormal Laboratory Findings Small reductions in hematocrit occurred more often in Acarbose Tablets-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. …
Source: FDA drug label, Strides Pharma Science Limited, effective July 15, 2026 (SPL set 656769ee-e292-4950-83df-a38e6b1a9d6e), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,847 reports list acarbose among the medicines taken, each a report of something that happened, not proof the medicine caused it; 316 are coded as a death and 2,096 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Acarbose: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions