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Glucotrol XL

Glucotrol XL(Glipizide Extended Release) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Glucotrol XL Side Effects Center

What Is Glucotrol?

Glucotrol XL (glipizide extended release) is an oral diabetes medicine that helps control blood sugar levels used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Glucotrol XL is available in generic form.

What Are Side Effects of Glucotrol?

Common side effects of Glucotrol XL include:

Tell your doctor if you have serious side effects of Glucotrol XL including:

  • signs of infection (such as persistent sore throat, fever),
  • easy bleeding or bruising,
  • stomach pain,
  • yellowing eyes or skin,
  • dark urine,
  • unusual tiredness or weakness,
  • unusual or sudden weight gain,
  • mental/mood changes,
  • swelling hands or feet, or
  • seizures.

Dosage for Glucotrol

The usual starting dose of Glucotrol XL is 5 mg per day. Dosage adjustment is based on laboratory measures of glycemic control. Most patients are controlled with 5 mg to 10 mg taken once daily. Some patients may require up to the maximum daily dose of 20 mg.

What Drugs, Substances, or Supplements Interact with Glucotrol?

Hyperglycemia (high blood sugar) may result if you take Glucotrol XL with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, diet pills, and medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Glucotrol XL with drugs that lower blood sugar, such as: nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, fluconazole, probenecid, or blood thinners.

Glucotrol During Pregnancy or Breastfeeding

Glucotrol XL should be used only when prescribed during pregnancy. It is not recommended for use for at least one month before delivery due to the potential for harm to a fetus. Insulin may be preferred during pregnancy. Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Glucotrol XL (glipizide extended release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Glucotrol XL Consumer Information

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

Call your doctor at once if you have symptoms of low blood sugar:

  • headache, irritability
  • sweating, fast heart rate;
  • dizziness, nausea; or
  • hunger, feeling anxious or shaky.

Common side effects may include:

  • diarrhea, constipation, gas;
  • dizziness, drowsiness;
  • tremors; or
  • skin rash, redness, 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 Glucotrol XL (Glipizide Extended Release)

 

Glucotrol XL Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 580 patients from 31 to 87 years of age received GLUCOTROL XL in doses from 5 mg to 60 mg in both controlled and open trials. The dosages above 20 mg are not recommended dosages. In these trials, approximately 180 patients were treated with GLUCOTROL XL for at least 6 months.

Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that were reported in pooled double-blind, placebo-controlled trials in ≥3% of GLUCOTROL XL-treated patients and more commonly than in patients who received placebo.

Table 1: Incidence (%) of Adverse Reactions Reported in ≥3% of Patients Treated in Placebo-Controlled Clinical Trials and More Commonly in Patients Treated with GLUCOTROL XL (Excluding Hypoglycemia)

  GLUCOTROL XL (%) Placebo (%)
(N=278) (N=69)
Adverse Effect    
Dizziness 6.8 5.8
Diarrhea 5.4 0.0
Nervousness 3.6 2.9
Tremor 3.6 0.0
Flatulence 3.2 1.4

Hypoglycemia

Of the 580 patients that received GLUCOTROL XL in clinical trials, 3.4% had hypoglycemia documented by a blood-glucose measurement <60 mg/dL and/or symptoms believed to be associated with hypoglycemia and 2.6% of patients discontinued for this reason. Hypoglycemia was not reported for any placebo patients.

Gastrointestinal Reactions

In clinical trials, the incidence of gastrointestinal (GI) side effects (nausea, vomiting, constipation, dyspepsia), occurred in less than 3% of GLUCOTROL XL-treated patients and were more common in GLUCOTROL XL-treated patients than those receiving placebo.

Dermatologic Reactions

In clinical trials, allergic skin reactions, i.e., urticaria occurred in less than 1.5% of treated patients and were more common in GLUCOTROL XL treated patients than those receiving placebo. These may be transient and may disappear despite continued use of glipizide XL; if skin reactions persist, the drug should be discontinued.

Laboratory Tests

Mild to moderate elevations of ALT, LDH, alkaline phosphatase, BUN and creatinine have been noted. The relationship of these abnormalities to glipizide is uncertain.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of GLUCOTROL XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Abdominal pain
  • Cholestatic and hepatocellular forms of liver injury accompanied by jaundice
  • Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia [see WARNINGS AND PRECAUTIONS], aplastic anemia, pancytopenia
  • Hepatic porphyria and disulfiram-like reactions
  • Hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion
  • Rash
  • There have been reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug with this nondissolvable extended release formulation.

Read the entire FDA prescribing information for Glucotrol XL (Glipizide Extended Release)

&Copy; Glucotrol XL Patient Information is supplied by Cerner Multum, Inc. and Glucotrol XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.