GLIPIZIDE

72/100 · Elevated

Manufactured by Roerig

Gliptizide Adverse Events Show High Seriousness and Diverse Reactions

115,301 FDA adverse event reports analyzed

Last updated: 2026-05-12

About GLIPIZIDE

GLIPIZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Roerig. Based on analysis of 115,301 FDA adverse event reports, GLIPIZIDE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for GLIPIZIDE include BLOOD GLUCOSE INCREASED, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GLIPIZIDE.

AI Safety Analysis

Glipizide has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 115,301 adverse event reports for this medication, which is primarily manufactured by Roerig.

The most commonly reported adverse events include Blood Glucose Increased, Nausea, Drug Ineffective. Of classified reports, 56.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gliptizide reports show a high percentage of serious adverse events (56.1%).

The most common reactions include nausea, dizziness, and hypoglycemia. There is a notable diversity in reported reactions, indicating a wide range of potential side effects.

Patients taking Glipizide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Gliptizide can interact with other drugs, and patients should be cautious about dose omissions, which can lead to hypoglycemia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 72/100

Glipizide received a safety concern score of 72/100 (elevated concern). This is based on a 56.1% serious event ratio across 59,527 classified reports. The score accounts for 115,301 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.

Top Adverse Reactions

BLOOD GLUCOSE INCREASED6,675 reports
NAUSEA4,443 reports
DRUG INEFFECTIVE3,505 reports
DIARRHOEA3,262 reports
FATIGUE2,995 reports
WEIGHT DECREASED2,812 reports
DIZZINESS2,439 reports
DYSPNOEA2,403 reports
BLOOD GLUCOSE DECREASED2,231 reports
VOMITING2,166 reports
ASTHENIA2,113 reports
PAIN2,066 reports
HEADACHE2,038 reports
DEATH2,034 reports
DECREASED APPETITE1,972 reports
CHRONIC KIDNEY DISEASE1,643 reports
FALL1,639 reports
MYOCARDIAL INFARCTION1,615 reports
RENAL FAILURE1,613 reports
OFF LABEL USE1,536 reports
ACUTE KIDNEY INJURY1,524 reports
CARDIAC FAILURE CONGESTIVE1,455 reports
MALAISE1,374 reports
PAIN IN EXTREMITY1,315 reports
HYPOGLYCAEMIA1,314 reports
CONSTIPATION1,309 reports
ARTHRALGIA1,289 reports
PNEUMONIA1,231 reports
WEIGHT INCREASED1,195 reports
PRURITUS1,184 reports
INJECTION SITE PAIN1,153 reports
RASH1,139 reports
ANXIETY1,132 reports
COUGH1,108 reports
DIABETES MELLITUS1,101 reports
CEREBROVASCULAR ACCIDENT1,095 reports
HYPERTENSION1,093 reports
BACK PAIN1,088 reports
CHEST PAIN1,065 reports
INSOMNIA1,041 reports
ABDOMINAL PAIN UPPER996 reports
DEPRESSION988 reports
FEELING ABNORMAL983 reports
ANAEMIA946 reports
URINARY TRACT INFECTION917 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED886 reports
OEDEMA PERIPHERAL883 reports
TREMOR878 reports
ABDOMINAL PAIN872 reports
DEHYDRATION872 reports
DRUG DOSE OMISSION864 reports
INCORRECT DOSE ADMINISTERED843 reports
GAIT DISTURBANCE806 reports
HYPOTENSION803 reports
BLADDER CANCER794 reports
ABDOMINAL DISCOMFORT785 reports
PYREXIA767 reports
DYSPEPSIA759 reports
MUSCLE SPASMS753 reports
CORONARY ARTERY DISEASE717 reports
SOMNOLENCE717 reports
CONFUSIONAL STATE699 reports
CONDITION AGGRAVATED698 reports
HYPERHIDROSIS681 reports
VISION BLURRED667 reports
PERIPHERAL SWELLING662 reports
ATRIAL FIBRILLATION660 reports
PRODUCT DOSE OMISSION ISSUE659 reports
BLOOD PRESSURE INCREASED641 reports
GASTROINTESTINAL HAEMORRHAGE636 reports
ALOPECIA631 reports
DRUG HYPERSENSITIVITY629 reports
MYALGIA622 reports
INJECTION SITE HAEMORRHAGE621 reports
DIABETES MELLITUS INADEQUATE CONTROL605 reports
DRUG INTERACTION603 reports
GASTROOESOPHAGEAL REFLUX DISEASE598 reports
HYPOAESTHESIA586 reports
END STAGE RENAL DISEASE583 reports
NASOPHARYNGITIS581 reports
ABDOMINAL DISTENSION566 reports
COMPLETED SUICIDE556 reports
CARDIAC DISORDER535 reports
PANCREATITIS527 reports
MEMORY IMPAIRMENT525 reports
RENAL FAILURE ACUTE524 reports
SEPSIS521 reports
PARAESTHESIA517 reports
PRODUCT QUALITY ISSUE517 reports
RENAL INJURY517 reports
LOSS OF CONSCIOUSNESS504 reports
HAEMOGLOBIN DECREASED501 reports
FLUSHING489 reports
NEUROPATHY PERIPHERAL478 reports
MUSCULAR WEAKNESS467 reports
VISUAL IMPAIRMENT463 reports
TYPE 2 DIABETES MELLITUS452 reports
RENAL IMPAIRMENT451 reports
FLATULENCE448 reports
BLOOD GLUCOSE ABNORMAL447 reports

Key Safety Signals

  • Hypoglycemia and other serious conditions like myocardial infarction and renal failure are key safety signals.
  • Drug interactions and dose omissions are frequent, highlighting potential risks.
  • Serious adverse events such as death and chronic kidney disease are reported.

Patient Demographics

Adverse event reports by sex: Female: 28,600, Male: 27,522, Unknown: 149. The most frequently reported age groups are age 70 (1,310 reports), age 67 (1,252 reports), age 65 (1,242 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 59,527 classified reports for GLIPIZIDE:

  • Serious: 33,423 reports (56.1%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 26,104 reports (43.9%)
Serious 56.1%Non-Serious 43.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female28,600 (50.8%)
Male27,522 (48.9%)
Unknown149 (0.3%)

Reports by Age

Age 701,310 reports
Age 671,252 reports
Age 651,242 reports
Age 721,236 reports
Age 681,219 reports
Age 661,209 reports
Age 691,172 reports
Age 731,150 reports
Age 631,149 reports
Age 641,118 reports
Age 621,112 reports
Age 711,102 reports
Age 751,077 reports
Age 591,061 reports
Age 611,059 reports
Age 601,055 reports
Age 761,012 reports
Age 74991 reports
Age 58973 reports
Age 57954 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Gliptizide can interact with other drugs, and patients should be cautious about dose omissions, which can lead to hypoglycemia.

What You Should Know

If you are taking Glipizide, here are important things to know. The most commonly reported side effects include blood glucose increased, nausea, drug ineffective, diarrhoea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood glucose levels regularly to prevent hypoglycemia. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

Regulators are monitoring the drug closely due to the high number of serious adverse events, particularly related to cardiovascular and renal issues.

Frequently Asked Questions

How many adverse event reports has the FDA received for Glipizide?

The FDA has received approximately 115,301 adverse event reports associated with Glipizide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What are the most commonly reported side effects of Glipizide?

The most frequently reported adverse events for Glipizide include Blood Glucose Increased, Nausea, Drug Ineffective, Diarrhoea, Fatigue. By volume, the top reported reactions are: Blood Glucose Increased (6,675 reports), Nausea (4,443 reports), Drug Ineffective (3,505 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Glipizide.

What percentage of Glipizide adverse event reports are serious?

Out of 59,527 classified reports, 33,423 (56.1%) were classified as serious and 26,104 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who reports adverse events for Glipizide (by sex)?

Adverse event reports for Glipizide break down by patient sex as follows: Female: 28,600, Male: 27,522, Unknown: 149. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Glipizide?

The most frequently reported age groups for Glipizide adverse events are: age 70: 1,310 reports, age 67: 1,252 reports, age 65: 1,242 reports, age 72: 1,236 reports, age 68: 1,219 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Glipizide?

The primary manufacturer associated with Glipizide adverse event reports is Roerig. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Glipizide?

Beyond the most common reactions, other reported adverse events for Glipizide include: Weight Decreased, Dizziness, Dyspnoea, Blood Glucose Decreased, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Glipizide?

You can report adverse events from Glipizide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Glipizide's safety score and what does it mean?

Glipizide has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Gliptizide reports show a high percentage of serious adverse events (56.1%).

What are the key safety signals for Glipizide?

Key safety signals identified in Glipizide's adverse event data include: Hypoglycemia and other serious conditions like myocardial infarction and renal failure are key safety signals.. Drug interactions and dose omissions are frequent, highlighting potential risks.. Serious adverse events such as death and chronic kidney disease are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Glipizide interact with other drugs?

Gliptizide can interact with other drugs, and patients should be cautious about dose omissions, which can lead to hypoglycemia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Glipizide.

What should patients know before taking Glipizide?

Monitor blood glucose levels regularly to prevent hypoglycemia. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking.

Are Glipizide side effects well-documented?

Glipizide has 115,301 adverse event reports on file with the FDA. The most common reactions include nausea, dizziness, and hypoglycemia. The volume of reports for Glipizide reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Glipizide?

Regulators are monitoring the drug closely due to the high number of serious adverse events, particularly related to cardiovascular and renal issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to GLIPIZIDE based on therapeutic use, drug class, or shared indications:

MetforminInsulinSulfonylureas
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.