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Precose Side Effects, and Drug Interactions - Acarbose

Precose Side Effects, and Drug Interactions - Acarbose

Digestive Tract

Gastrointestinal symptoms are the most common reactions to PRECOSE ®. 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 PRECOSE ® 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 PRECOSE ® are a manifestation of the mechanism of action of PRECOSE® and are related to the presence of undigested carbohydrate in the lower GI tract. Rarely, these gastrointestinal events may be severe and might be confused with paralytic ileus.

Elevated Serum Transaminase Levels

See PRECAUTIONS

Other Abnormal Laboratory Findings

Small reductions in hematocrit occurred more often in PRECOSE ® -treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with PRECOSE ® therapy but are thought to be either spurious or of no clinical significance.

Hypersensitive Skin Reactions

Rarely, hypersensitive skin reactions such as rash may occur.

Edema

In rare instances edema has been reported

DRUG INTERACTIONS

(See PRECAUTIONS - Drug Interactions or CLINICAL PHARMACOLOGY - Drug-Drug Interactions )

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