INSULIN GLULISINE

N/A

Manufactured by sanofi-aventis U.S. LLC

19,263 FDA adverse event reports analyzed

Last updated: 2026-04-14

About INSULIN GLULISINE

INSULIN GLULISINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by sanofi-aventis U.S. LLC. The most commonly reported adverse reactions for INSULIN GLULISINE include BLOOD GLUCOSE INCREASED, HYPOGLYCAEMIA, HYPERGLYCAEMIA, DRUG INEFFECTIVE, BLOOD GLUCOSE DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INSULIN GLULISINE.

Top Adverse Reactions

BLOOD GLUCOSE INCREASED1,526 reports
HYPOGLYCAEMIA756 reports
HYPERGLYCAEMIA634 reports
DRUG INEFFECTIVE567 reports
BLOOD GLUCOSE DECREASED444 reports
DIZZINESS401 reports
MALAISE392 reports
DYSPNOEA383 reports
NAUSEA370 reports
VOMITING335 reports
ACUTE KIDNEY INJURY304 reports
FATIGUE297 reports
ASTHENIA293 reports
DIARRHOEA279 reports
PAIN271 reports
FALL269 reports
BLOOD GLUCOSE ABNORMAL267 reports
DIABETES MELLITUS INADEQUATE CONTROL263 reports
HEADACHE259 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED253 reports
OFF LABEL USE250 reports
RENAL FAILURE241 reports
DIABETIC KETOACIDOSIS240 reports
VISUAL IMPAIRMENT239 reports
HYPERHIDROSIS234 reports
PRODUCT QUALITY ISSUE224 reports
WEIGHT DECREASED209 reports
PNEUMONIA208 reports
DEATH207 reports
LOSS OF CONSCIOUSNESS203 reports
CEREBROVASCULAR ACCIDENT195 reports
WEIGHT INCREASED194 reports
ANAEMIA190 reports
PYREXIA183 reports
BLOOD GLUCOSE FLUCTUATION182 reports
PAIN IN EXTREMITY181 reports
CONDITION AGGRAVATED180 reports
WRONG DRUG ADMINISTERED173 reports
PRURITUS166 reports
TREMOR165 reports
COUGH164 reports
HYPERTENSION164 reports
GENERAL PHYSICAL HEALTH DETERIORATION162 reports
CONFUSIONAL STATE161 reports
FEELING ABNORMAL161 reports
GAIT DISTURBANCE161 reports
PRODUCT STORAGE ERROR160 reports
DECREASED APPETITE159 reports
MYOCARDIAL INFARCTION156 reports
SYNCOPE156 reports
INJECTION SITE PAIN155 reports
CHEST PAIN151 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION150 reports
URINARY TRACT INFECTION149 reports
HYPOTENSION146 reports
DEHYDRATION141 reports
RASH139 reports
VISION BLURRED138 reports
OEDEMA PERIPHERAL137 reports
DRUG INTERACTION135 reports
ARTHRALGIA132 reports
PRODUCT USE ISSUE128 reports
ABDOMINAL PAIN UPPER120 reports
CATARACT117 reports
DRUG DOSE OMISSION113 reports
PERIPHERAL SWELLING112 reports
ABDOMINAL PAIN110 reports
SOMNOLENCE102 reports
HOSPITALISATION100 reports
DRUG ADMINISTRATION ERROR98 reports
GASTROINTESTINAL HAEMORRHAGE96 reports
BACK PAIN95 reports
BALANCE DISORDER95 reports
DEVICE MALFUNCTION93 reports
HYPERKALAEMIA90 reports
CARDIAC FAILURE88 reports
BLOOD PRESSURE INCREASED86 reports
KETOACIDOSIS85 reports
METABOLIC ACIDOSIS85 reports
SEPSIS85 reports
DIABETES MELLITUS83 reports
HAEMATOMA83 reports
NEUROPATHY PERIPHERAL83 reports
DRUG HYPERSENSITIVITY80 reports
ERYTHEMA80 reports
HYPERSENSITIVITY79 reports
MYALGIA79 reports
PRODUCT DOSE OMISSION ISSUE79 reports
DEPRESSION78 reports
EXPIRED PRODUCT ADMINISTERED78 reports
URTICARIA78 reports
BLINDNESS77 reports
NASOPHARYNGITIS77 reports
CONSTIPATION76 reports
RENAL IMPAIRMENT76 reports
CHRONIC KIDNEY DISEASE75 reports
CONTUSION75 reports
DEVICE ISSUE75 reports
OVERDOSE75 reports
URINARY INCONTINENCE75 reports

Report Outcomes

Out of 9,945 classified reports for INSULIN GLULISINE:

Serious 75.6%Non-Serious 24.4%

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

Female4,904 (52.7%)
Male4,362 (46.9%)
Unknown40 (0.4%)

Reports by Age

Age 64263 reports
Age 63256 reports
Age 65219 reports
Age 62214 reports
Age 70199 reports
Age 72194 reports
Age 61192 reports
Age 71189 reports
Age 67185 reports
Age 60183 reports
Age 73179 reports
Age 68175 reports
Age 69175 reports
Age 55173 reports
Age 66173 reports
Age 74173 reports
Age 58167 reports
Age 57158 reports
Age 59157 reports
Age 76156 reports

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

Frequently Asked Questions

How many FDA adverse event reports are associated with INSULIN GLULISINE?

This profile reflects 19,263 FDA FAERS reports that mention INSULIN GLULISINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for INSULIN GLULISINE?

Frequently reported terms in FAERS include BLOOD GLUCOSE INCREASED, HYPOGLYCAEMIA, HYPERGLYCAEMIA, DRUG INEFFECTIVE, BLOOD GLUCOSE DECREASED, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures INSULIN GLULISINE?

Labeling and FAERS entries often list sanofi-aventis U.S. LLC in connection with INSULIN GLULISINE. Always verify the specific product and NDC with your pharmacist.

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.