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Precose

Last reviewed on RxList: 1/31/2017
Precose Side Effects Center

Last reviewed on RxList 12/13/2016

Precose (acarbose tablets) is an oral alpha-glucosidase inhibitor used to treat type 2 diabetes. Precose is sometimes used in combination with insulin or other diabetes medications you take by mouth. Precose is available in generic form. Common side effects of Precose include:

  • diarrhea,
  • gas,
  • bloating,
  • upset stomach, or
  • stomach pain in the first few weeks of treatment as your body adjusts to this medication but usually improve with time.

Other side effects of Precose include skin rash or itching. Tell your doctor if you have rare but very serious side effects of Precose including:

  • unusual tiredness,
  • persistent nausea or vomiting,
  • severe stomach or abdominal pain,
  • rectal bleeding,
  • yellowing eyes or skin, or
  • dark urine.

There is no fixed dosage regimen for the management of diabetes mellitus with Precose. Dosage is individualized on the basis of effectiveness and tolerance. The maximum dose should not exceed 100 mg three times per day. Precose may interact with isoniazid, digoxin, niacin, nicotine patches or gum, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medications, cold or asthma medications, diet pills, stimulants, or medicines to treat ADHD, or calcium channel blockers. Tell your doctor all medications you are taking. During pregnancy, Precose should be used only when prescribed. Your doctor may substitute insulin for this drug during your pregnancy. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Precose (acarbose tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Precose Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain, severe constipation;
  • diarrhea that is watery or bloody;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach pain, gas, bloating;
  • mild diarrhea; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Precose (Acarbose)

Precose Professional Information

SIDE EFFECTS

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.

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 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.

Postmarketing Adverse Event Reports

Additional adverse events reported from worldwide postmarketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoides intestinalis (see PRECAUTIONS).

Pneumatosis Cystoides Intestinalis

There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with the use of alpha-glucosidase inhibitors, including Precose. Pneumatosis cystoides intestinalis may present with symptoms of diarrhea, mucus discharge, rectal bleeding, and constipation. Complications may include pneumoperitoneum, volvulus, intestinal obstruction, intussusception, intestinal hemorrhage, and intestinal perforation. If pneumatosis cystoides intestinalis is suspected, discontinue Precose and perform the appropriate diagnostic imaging.

Read the entire FDA prescribing information for Precose (Acarbose)

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