Glucotrol XL Side Effects

Generic Name: Glipizide

Please note - some side effects for Glucotrol XL may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Glucotrol XL - for the consumer

Glucotrol XL Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Glucotrol XL Extended-Release Tablets:

Diarrhea; dizziness; gas; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; skin redness; dizziness); confusion; dark urine; fainting; fever, chills, or persistent sore throat; irregular heartbeat; low blood sugar symptoms (eg, anxiety, drowsiness, fast heartbeat, headache, lightheadedness, severe or persistent dizziness, tremors, unusual sweating, weakness); severe or persistent blurred vision or other vision problems; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

For the professional

Glucotrol XL

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 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 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-treated patients include:

The following adverse experiences occurred with an incidence of less than 3% in Glucotrol XL-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, 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:

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.

More resources:

Glucotrol

Glucotrol XL

Glipizide

Glucotrol XL Extended-Release Tablets

Glucotrol XL - Includes detailed dosage instructions.

Glucotrol XL

Glipizide

Glipizide

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