What the label lists and what reports show
Miglitol side effects
Miglitol's FDA label: “Gastrointestinal symptoms are the most common reactions to miglitol tablets.” FAERS holds 947 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 (68 reports).
- Generic listed
Check it at the source: the miglitol FDA label on DailyMed (effective April 1, 2022, Proficient Rx LP); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsGastrointestinal symptoms are the most common reactions to miglitol tablets.
From the label: adverse reactions, continuedGastrointestinal Gastrointestinal symptoms are the most common reactions to miglitol tablets. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 11.7%, 28.7%, and 41.5% respectively in 962 patients treated with miglitol tablets, 25 mg to 100 mg 3 times daily, whereas the corresponding incidences were 4.7%, 10.0%, and 12.0% in 603 placebo-treated patients. The incidence of diarrhea and abdominal pain tended to diminish with continued treatment. Dermatologic Skin rash was reported in 4.3% of patients treated with miglitol tablets compared to 2.4% of placebo-treated patients. Rashes were generally transient and most were assessed as unrelated to miglitol tablets by physician investigators. Abnormal Laboratory Findings Low serum iron occurred more often in patients treated with miglitol tablets (9.2%) than in placebo-treated patients (4.2%) but did not persist in the majority of cases and was not associated with reductions in hemoglobin or changes in other hematologic indices. Postmarketing Experience The following adverse reactions have been reported during post-approval use of miglitol tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …
Source: FDA drug label, ANDA203965 (Orient Pharma), as published by Proficient Rx LP, effective April 1, 2022 (SPL set f16ecb50-e54e-43e1-8789-eaf5bc94f332), via openFDA; the full label on DailyMed
What do FAERS reports show?
947 reports list miglitol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 106 are coded as a death and 560 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, 4 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?
- Miglitol: 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