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Glucotrol XL

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Glucotrol XL

Glucotrol XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Glucotrol XL (glipizide extended release) is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. It is an oral diabetes medicine that helps control blood sugar levels. This medication is available in generic form. Common side effects include nausea, vomiting, loss of appetite, diarrhea, constipation, upset stomach, gas, headache, and weight gain.

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. 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: non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, fluconazole, probenecid, or blood thinners. 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 breast-feeding.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Glucotrol XL in Detail - Patient Information: Side Effects

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.

Stop taking glipizide and call your doctor at once if you have a serious side effect such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums), feeling tired or short of breath, rapid heart rate;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, fever, confusion; or
  • throbbing headache, severe nausea and vomiting, fast or pounding heartbeats, sweating or thirst, feeling like you might pass out.

Less serious side effects may include:

  • mild nausea;
  • diarrhea, constipation;
  • dizziness, drowsiness; 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Glucotrol XL Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, loss of appetite, diarrhea, constipation, upset stomach, gas, headache, and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as persistent sore throat, fever), easy bleeding/bruising, stomach pain, yellowing eyes/skin, dark urine, unusual tiredness/weakness, unusual/sudden weight gain, mental/mood changes, swelling hands/feet, seizures.

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Glucotrol XL (Glipizide Extended Release)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Glucotrol XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In U.S. controlled studies the frequency of serious adverse experiences reported was very low and causal relationship has not been established.

The 580 patients from 31 to 87 years of age who received GLUCOTROL XL (glipizide extended release) Extended Release Tablets in doses from 5 mg to 60 mg in both controlled and open trials were included in the evaluation of adverse experiences. All adverse experiences reported were tabulated independently of their possible causal relation to medication.

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Only 3.4% of patients receiving GLUCOTROL XL (glipizide extended release) Extended Release Tablets had hypoglycemia documented by a blood-glucose measurement < 60 mg/dL and/or symptoms believed to be associated with hypoglycemia. In a comparative efficacy study of GLUCOTROL XL and Glucotrol, hypoglycemia occurred rarely with an incidence of less than 1% with both drugs.

In double-blind, placebo-controlled studies the adverse experiences reported with an incidence of 3% or more in GLUCOTROL XL (glipizide extended release) - treated patients include:

Adverse Effect GLUCOTROL XL (%)
(N=278)
Placebo (%)
(N=69)
Asthenia 10.1 13.0
Headache 8.6 8.7
Dizziness 6.8 5.8
Nervousness 3.6 2.9
Tremor 3.6 0.0
Diarrhea 5.4 0.0
Flatulence 3.2 1.4

The following adverse experiences occurred with an incidence of less than 3% in GLUCOTROL XL (glipizide extended release) -treated patients:

Body as a whole - pain
Nervous system - insomnia, paresthesia, anxiety, depression and hypesthesia
Gastrointestinal - nausea, dyspepsia, constipation and vomiting
Metabolic - hypoglycemia
Musculoskeletal - arthralgia, leg cramps and myalgia
Cardiovascular - syncope
Skin - sweating and pruritus
Respiratory - rhinitis
Special senses - blurred vision
Urogenital - polyuria

Other adverse experiences occurred with an incidence of less than 1% in GLUCOTROL XL-treated patients:

Body as a whole - chills
Nervous system - hypertonia, confusion, vertigo, somnolence, gait abnormality and decreased libido
Gastrointestinal - anorexia and trace blood in stool
Metabolic - thirst and edema
Cardiovascular - arrhythmia, migraine, flushing and hypertension
Skin - rash and urticaria
Respiratory - pharyngitis and dyspnea
Special senses - pain in the eye, conjunctivitis and retinal hemorrhage
Urogenital - dysuria

Although these adverse experiences occurred in patients treated with GLUCOTROL XL, a causal relationship to the medication has not been established in all cases.

There have been rare reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug in this non-deformable sustained release formulation, although causal relationship to the drug is uncertain.

In post-marketing experience of GLUCOTROL XL (glipizide extended release) , the additional adverse reaction of abdominal pain has been reported.

The following are adverse experiences reported with immediate release glipizide and other sulfonylureas, but have not been observed with GLUCOTROL XL (glipizide extended release) :

Hematologic

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic

Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. In the mouse, glipizide pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that glipizide has an extremely low incidence of disulfiram-like alcohol reactions.

Endocrine Reactions

Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with glipizide and other sulfonylureas.

Laboratory Tests

The pattern of laboratory test abnormalities observed with glipizide was similar to that for other sulfonylureas. Occasional mild to moderate elevations of SGOT, LDH, alkaline phosphatase, BUN and creatinine were noted. One case of jaundice was reported. The relationship of these abnormalities to glipizide is uncertain, and they have rarely been associated with clinical symptoms.

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

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Glucotrol XL - User Reviews

Glucotrol XL User Reviews

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Here is a collection of user reviews for the medication Glucotrol XL sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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