GLIPIZIDE TABLETS

65/100 · Elevated

Manufactured by ANI Pharmaceuticals, Inc.

Glipill Safety Profile: Moderate Concern with Common Gastrointestinal and Hypoglycemia Reactions

96,589 FDA adverse event reports analyzed

Last updated: 2026-05-12

About GLIPIZIDE TABLETS

GLIPIZIDE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 96,589 FDA adverse event reports, GLIPIZIDE TABLETS has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for GLIPIZIDE TABLETS 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 TABLETS.

AI Safety Analysis

Glipizide-Tablets has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 96,589 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..

The most commonly reported adverse events include Blood Glucose Increased, Nausea, Drug Ineffective. Of classified reports, 54.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Glipill tablets are associated with a high incidence of gastrointestinal side effects such as nausea, diarrhea, and vomiting.

Hypoglycemia is a significant concern, with 1,145 reports of this adverse event. The drug is also linked to serious conditions like chronic kidney disease and acute kidney injury, though less frequently reported.

Patients taking Glipizide-Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Glipill may interact with other drugs, such as beta-blockers, ACE inhibitors, and diuretics, potentially leading to hypoglycemia or other adverse effects. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 65/100

Glipizide-Tablets received a safety concern score of 65/100 (elevated concern). This is based on a 54.7% serious event ratio across 50,703 classified reports. The score accounts for 96,589 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 INCREASED5,528 reports
NAUSEA3,660 reports
DRUG INEFFECTIVE3,016 reports
DIARRHOEA2,917 reports
FATIGUE2,629 reports
WEIGHT DECREASED2,253 reports
DIZZINESS2,065 reports
DYSPNOEA2,042 reports
VOMITING1,844 reports
BLOOD GLUCOSE DECREASED1,821 reports
ASTHENIA1,782 reports
HEADACHE1,738 reports
PAIN1,720 reports
DECREASED APPETITE1,629 reports
DEATH1,613 reports
CHRONIC KIDNEY DISEASE1,528 reports
OFF LABEL USE1,426 reports
FALL1,420 reports
ACUTE KIDNEY INJURY1,396 reports
RENAL FAILURE1,390 reports
MALAISE1,187 reports
HYPOGLYCAEMIA1,145 reports
CONSTIPATION1,144 reports
PAIN IN EXTREMITY1,120 reports
ARTHRALGIA1,093 reports
PNEUMONIA1,068 reports
INJECTION SITE PAIN1,065 reports
PRURITUS1,055 reports
MYOCARDIAL INFARCTION996 reports
RASH995 reports
CARDIAC FAILURE CONGESTIVE974 reports
COUGH959 reports
WEIGHT INCREASED950 reports
ANXIETY894 reports
BACK PAIN886 reports
INSOMNIA881 reports
HYPERTENSION865 reports
ABDOMINAL PAIN UPPER848 reports
FEELING ABNORMAL818 reports
DRUG DOSE OMISSION814 reports
CHEST PAIN806 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED799 reports
DIABETES MELLITUS793 reports
DEPRESSION785 reports
INCORRECT DOSE ADMINISTERED770 reports
ANAEMIA766 reports
URINARY TRACT INFECTION757 reports
CEREBROVASCULAR ACCIDENT750 reports
DEHYDRATION746 reports
ABDOMINAL PAIN740 reports
TREMOR740 reports
ABDOMINAL DISCOMFORT713 reports
GAIT DISTURBANCE704 reports
OEDEMA PERIPHERAL684 reports
HYPOTENSION669 reports
PYREXIA645 reports
PRODUCT DOSE OMISSION ISSUE635 reports
MUSCLE SPASMS632 reports
PERIPHERAL SWELLING624 reports
SOMNOLENCE618 reports
DYSPEPSIA616 reports
CONDITION AGGRAVATED600 reports
CONFUSIONAL STATE598 reports
ALOPECIA576 reports
BLOOD PRESSURE INCREASED555 reports
INJECTION SITE HAEMORRHAGE553 reports
COMPLETED SUICIDE550 reports
DRUG INTERACTION550 reports
HYPERHIDROSIS549 reports
ATRIAL FIBRILLATION548 reports
VISION BLURRED548 reports
GASTROINTESTINAL HAEMORRHAGE547 reports
END STAGE RENAL DISEASE531 reports
MYALGIA508 reports
NASOPHARYNGITIS503 reports
DRUG HYPERSENSITIVITY491 reports
HYPOAESTHESIA484 reports
PRODUCT QUALITY ISSUE482 reports
GASTROOESOPHAGEAL REFLUX DISEASE470 reports
MEMORY IMPAIRMENT463 reports
DIABETES MELLITUS INADEQUATE CONTROL460 reports
RENAL INJURY459 reports
ABDOMINAL DISTENSION445 reports
PARAESTHESIA441 reports
LOSS OF CONSCIOUSNESS434 reports
PANCREATITIS432 reports
VISUAL IMPAIRMENT432 reports
HAEMOGLOBIN DECREASED425 reports
CORONARY ARTERY DISEASE419 reports
SEPSIS419 reports
FLUSHING415 reports
RENAL FAILURE ACUTE411 reports
MUSCULAR WEAKNESS405 reports
TOXICITY TO VARIOUS AGENTS404 reports
NEUROPATHY PERIPHERAL398 reports
BLOOD GLUCOSE ABNORMAL392 reports
CARDIAC DISORDER386 reports
RENAL IMPAIRMENT384 reports
PRODUCT USE ISSUE380 reports
FLATULENCE376 reports

Key Safety Signals

  • Hypoglycemia
  • Gastrointestinal issues
  • Renal impairment

Patient Demographics

Adverse event reports by sex: Female: 24,254, Male: 24,032, Unknown: 127. The most frequently reported age groups are age 70 (1,120 reports), age 67 (1,093 reports), age 72 (1,066 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 50,703 classified reports for GLIPIZIDE TABLETS:

  • Serious: 27,744 reports (54.7%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 22,959 reports (45.3%)
Serious 54.7%Non-Serious 45.3%

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

Female24,254 (50.1%)
Male24,032 (49.6%)
Unknown127 (0.3%)

Reports by Age

Age 701,120 reports
Age 671,093 reports
Age 721,066 reports
Age 681,065 reports
Age 651,060 reports
Age 661,047 reports
Age 731,036 reports
Age 691,016 reports
Age 71976 reports
Age 64959 reports
Age 63947 reports
Age 62938 reports
Age 59911 reports
Age 75910 reports
Age 60897 reports
Age 61894 reports
Age 76890 reports
Age 74869 reports
Age 58805 reports
Age 77798 reports

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

Drug Interactions & Warnings

Glipill may interact with other drugs, such as beta-blockers, ACE inhibitors, and diuretics, potentially leading to hypoglycemia or other adverse effects. Patients should inform their healthcare provider of all medications they are taking.

What You Should Know

If you are taking Glipizide-Tablets, 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, especially if you experience symptoms of hypoglycemia such as dizziness, sweating, or confusion. Report any unusual symptoms to your healthcare provider promptly. 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

The FDA has not issued specific warnings for Glipill, but patients should be monitored for signs of hypoglycemia and renal impairment, especially in elderly patients.

Frequently Asked Questions

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

The FDA has received approximately 96,589 adverse event reports associated with Glipizide-Tablets. 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-Tablets?

The most frequently reported adverse events for Glipizide-Tablets include Blood Glucose Increased, Nausea, Drug Ineffective, Diarrhoea, Fatigue. By volume, the top reported reactions are: Blood Glucose Increased (5,528 reports), Nausea (3,660 reports), Drug Ineffective (3,016 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-Tablets.

What percentage of Glipizide-Tablets adverse event reports are serious?

Out of 50,703 classified reports, 27,744 (54.7%) were classified as serious and 22,959 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-Tablets (by sex)?

Adverse event reports for Glipizide-Tablets break down by patient sex as follows: Female: 24,254, Male: 24,032, Unknown: 127. 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-Tablets?

The most frequently reported age groups for Glipizide-Tablets adverse events are: age 70: 1,120 reports, age 67: 1,093 reports, age 72: 1,066 reports, age 68: 1,065 reports, age 65: 1,060 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-Tablets?

The primary manufacturer associated with Glipizide-Tablets adverse event reports is Ani Pharmaceuticals, Inc.. 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-Tablets?

Beyond the most common reactions, other reported adverse events for Glipizide-Tablets include: Weight Decreased, Dizziness, Dyspnoea, Vomiting, Blood Glucose Decreased. 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-Tablets?

You can report adverse events from Glipizide-Tablets 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-Tablets's safety score and what does it mean?

Glipizide-Tablets has a safety concern score of 65 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. Glipill tablets are associated with a high incidence of gastrointestinal side effects such as nausea, diarrhea, and vomiting.

What are the key safety signals for Glipizide-Tablets?

Key safety signals identified in Glipizide-Tablets's adverse event data include: Hypoglycemia. Gastrointestinal issues. Renal impairment. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Glipizide-Tablets interact with other drugs?

Glipill may interact with other drugs, such as beta-blockers, ACE inhibitors, and diuretics, potentially leading to hypoglycemia or other adverse effects. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Glipizide-Tablets.

What should patients know before taking Glipizide-Tablets?

Monitor blood glucose levels regularly, especially if you experience symptoms of hypoglycemia such as dizziness, sweating, or confusion. Report any unusual symptoms to your healthcare provider promptly.

Are Glipizide-Tablets side effects well-documented?

Glipizide-Tablets has 96,589 adverse event reports on file with the FDA. Hypoglycemia is a significant concern, with 1,145 reports of this adverse event. The volume of reports for Glipizide-Tablets reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Glipizide-Tablets?

The FDA has not issued specific warnings for Glipill, but patients should be monitored for signs of hypoglycemia and renal impairment, especially in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

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

beta-blockersACE inhibitorsdiuretics
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.