Acarbose Side Effects

Reported Acarbose side effects

Digestive effects In US placebo-controlled trials, flatulence, diarrhea and abdominal pain occurred in 74, 31 and 19 percent of 1,255 people taking acarbose at 50 to 300 mg three times a day, against 29, 12 and 9 percent of 999 people on placebo (US prescribing information for Precose). The label attributes these effects to undigested carbohydrate reaching the lower gut, and in a one-year study they tended to lessen over time (US prescribing information for Precose). In the STOP-NIDDM trial, 31 percent of people on acarbose and 19 percent on placebo stopped treatment early, and flatulence and diarrhea were the most frequent side effects (PMID: 12086760). In the ACE trial, gastrointestinal disorders were the most common adverse events leading to stopping or changing the study drug, in 7 percent on acarbose and 5 percent on placebo (PMID: 28917545). A 2018 Cochrane review of two prevention trials found non-serious adverse events, mainly gastrointestinal, in 96.9 percent of people on acarbose and 93.3 percent on placebo (PMID: 30592787). Liver enzymes and hepatitis In US studies of up to 12 months that included doses up to 300 mg three times a day, rises in the liver enzymes AST or ALT above 3 times the upper limit of normal occurred in 3 percent of people on acarbose and 1 percent on placebo; the rises were asymptomatic, reversible, more common in women and dose related, and in US studies with doses up to 100 mg three times a day, rises at any level were similar with acarbose and placebo (US prescribing information for Precose). The label lists 62 international postmarketing cases of transaminases above 500 IU/L, 29 of them with jaundice, in about 3 million patient-years, and reports cases of fulminant hepatitis with fatal outcome whose relationship to acarbose is unclear (US prescribing information for Precose). A 2006 case report described a 57-year-old woman with type 2 diabetes whose ALT reached 640 U/L on acarbose and returned to normal after acarbose was stopped, a reaction the authors rated as probable (PMID: 16317107). Other label warnings The label states that acarbose given alone should not cause hypoglycemia, but acarbose added to a sulfonylurea or insulin can lower blood glucose further, and very rare cases of hypoglycemic shock have been reported with these combinations (US prescribing information for Precose). The label also lists rare postmarketing reports of pneumatosis cystoides intestinalis, gas-filled cysts in the bowel wall, with complications that can include bleeding, intestinal obstruction and perforation, and reports of ileus, skin hypersensitivity reactions, edema and low platelet counts (US prescribing information for Precose). Small falls in hematocrit were more common with acarbose than with placebo (US prescribing information for Precose). Animal toxicology In a 104-week study and its repeat, Sprague-Dawley rats fed very high doses of acarbose had more kidney tumors and benign Leydig cell tumors; the rise in kidney tumors did not recur when carbohydrate deprivation was prevented with added glucose or when acarbose was given by gavage after meals, no increase in kidney tumors was found in Wistar rats, and two hamster studies showed no evidence of carcinogenicity (US prescribing information for Precose). In the Interventions Testing Program, acarbose lowered body weight in mice, more in females than in males (PMID: 24245565).

When to continue, reduce, or stop Acarbose

Acarbose contraindications

The US label contraindicates acarbose in known hypersensitivity, diabetic ketoacidosis, cirrhosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or a predisposition to it, chronic intestinal diseases with marked disorders of digestion or absorption, and conditions that may worsen with increased gas in the intestine (US prescribing information for Precose). People with severe kidney impairment reached about 5 times higher peak plasma levels of acarbose, and the label states that treatment is not recommended when serum creatinine is above 2.0 mg/dL because long-term trials in that group were not done (US prescribing information for Precose). Acarbose can raise serum transaminases (liver enzymes), and the label calls for transaminase checks every 3 months during the first year of treatment and periodically after that (US prescribing information for Precose). Acarbose can add to the hypoglycemia risk of sulfonylureas or insulin, and because acarbose blocks the digestion of table sugar, the label states that oral glucose (dextrose) rather than sucrose should be used to treat mild to moderate hypoglycemia (US prescribing information for Precose). The label addresses pregnancy and breastfeeding as well as children: it reports no adequate studies in pregnant women, states that acarbose should not be given to nursing women, and notes that safety and effectiveness in children have not been established (US prescribing information for Precose). For aging use, the lifespan results come from mice (PMID: 24245565, PMID: 30688027), and no human trial has measured an effect of acarbose on aging; the two small registered aging studies in older adults posted no usable results (ClinicalTrials.gov NCT02865499, NCT02953093).

Why vendor quality drives Acarbose side-effect frequency

Research-compound communities consistently report that adverse-event frequency tracks with source quality. Three reasons: (1) impurity profiles vary by lab (residual synthesis byproducts can trigger reactions); (2) mislabeled mass means actual dose can be 50-150% of stated dose; (3) reconstitution-grade water and capping methodology affect long-term storage stability. COA-verified vendors with published HPLC data minimize all three failure modes. Check a vendor's COA record and Trust Score before you buy.

Acarbose side effects FAQ

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