Drug profile
Acarbose
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Dosage of acarbose tablets must be individualized on the basis of both
effectiveness and tolerance while not exceeding the maximum recommended dose of
100 mg t.i.d.
Source: US FDA label for acarbose (Acarbose), section 'dosage and administration',
retrieved 2026-08-29
- Initial Dosage The recommended starting dosage of acarbose tablets is 25 mg given
orally three times daily at the start (with the first bite) of each main meal.
Source: US FDA label for acarbose (Acarbose), section 'dosage and administration',
retrieved 2026-08-29
- This may be achieved by initiating treatment at 25 mg once per day and
subsequently increasing the frequency of administration to achieve 25 mg t.i.d.
Source: US FDA label for acarbose (Acarbose), section 'dosage and administration',
retrieved 2026-08-29
CHILD
- Safety and effectiveness of acarbose tablets in pediatric patients have not been
established.
Source: US FDA label for acarbose (Acarbose), section 'pediatric use', retrieved
2026-08-29
RENAL IMPAIRMENT
- No kidney-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for acarbose (Acarbose), retrieved
2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for acarbose (Acarbose), retrieved
2026-08-29
PREGNANCY
- Teratogenic Effects: Pregnancy Category B.
Source: US FDA label for acarbose (Acarbose), section 'pregnancy', retrieved
2026-08-29
- The safety of acarbose tablets in pregnant women has not been established.
Source: US FDA label for acarbose (Acarbose), section 'pregnancy', retrieved
2026-08-29
- Reproduction studies have been performed in rats at doses up to 480 mg/kg
(corresponding to 9 times the exposure in humans, based on drug blood levels) and
have revealed no evidence of impaired fertility or harm to the fetus due to
acarbose.
Source: US FDA label for acarbose (Acarbose), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- A small amount of radioactivity has been found in the milk of lactating rats after
administration of radiolabeled acarbose.
Source: US FDA label for acarbose (Acarbose), section 'nursing mothers', retrieved
2026-08-29
- It is not known whether this drug is excreted in human milk.
Source: US FDA label for acarbose (Acarbose), section 'nursing mothers', retrieved
2026-08-29
- Because many drugs are excreted in human milk, acarbose tablets should not be
administered to a nursing woman.
Source: US FDA label for acarbose (Acarbose), section 'nursing mothers', retrieved
2026-08-29