Glipizide ER Side Effects

Please note - some side effects for Glipizide ER 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).

For the professional

Glipizide ER

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 glipizide 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 glipizide 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 glipizide extended-release tablets and glipizide tablets, 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 glipizide-treated patients include:

The following adverse experiences occurred with an incidence of less than 3% in glipizide-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 glipizide-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 glipizide, 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.

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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.