HUMAN INSULIN

N/A

Manufactured by Novo Nordisk

24,125 FDA adverse event reports analyzed

Last updated: 2026-04-14

About HUMAN INSULIN

HUMAN INSULIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. The most commonly reported adverse reactions for HUMAN INSULIN include BLOOD GLUCOSE INCREASED, BLOOD GLUCOSE DECREASED, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HUMAN INSULIN.

Top Adverse Reactions

BLOOD GLUCOSE INCREASED2,004 reports
BLOOD GLUCOSE DECREASED717 reports
NAUSEA681 reports
DRUG INEFFECTIVE628 reports
DIARRHOEA502 reports
DYSPNOEA500 reports
DIZZINESS459 reports
FATIGUE452 reports
HYPOGLYCAEMIA445 reports
MALAISE388 reports
FALL386 reports
VOMITING380 reports
HEADACHE375 reports
DEATH373 reports
ASTHENIA366 reports
WEIGHT DECREASED365 reports
RENAL FAILURE351 reports
PAIN347 reports
PNEUMONIA344 reports
WEIGHT INCREASED303 reports
MYOCARDIAL INFARCTION301 reports
DECREASED APPETITE298 reports
HYPERTENSION290 reports
CEREBROVASCULAR ACCIDENT288 reports
PAIN IN EXTREMITY287 reports
DIABETES MELLITUS INADEQUATE CONTROL282 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED255 reports
CARDIAC FAILURE CONGESTIVE242 reports
CHRONIC KIDNEY DISEASE241 reports
DIABETES MELLITUS238 reports
HYPERGLYCAEMIA230 reports
ARTHRALGIA222 reports
ANAEMIA221 reports
ACUTE KIDNEY INJURY218 reports
OFF LABEL USE211 reports
CHEST PAIN210 reports
RASH210 reports
CONSTIPATION208 reports
PYREXIA207 reports
PRURITUS206 reports
VISUAL IMPAIRMENT206 reports
ANXIETY204 reports
FEELING ABNORMAL203 reports
BLOOD GLUCOSE FLUCTUATION201 reports
PRODUCT QUALITY ISSUE201 reports
BACK PAIN199 reports
DEHYDRATION198 reports
URINARY TRACT INFECTION198 reports
CONDITION AGGRAVATED195 reports
OEDEMA PERIPHERAL192 reports
COUGH189 reports
HYPERHIDROSIS188 reports
SEPSIS182 reports
INSOMNIA181 reports
HYPOTENSION180 reports
VISION BLURRED177 reports
DIABETIC KETOACIDOSIS174 reports
DEPRESSION172 reports
LOSS OF CONSCIOUSNESS169 reports
ABDOMINAL PAIN163 reports
NEUROPATHY PERIPHERAL159 reports
ATRIAL FIBRILLATION157 reports
BLOOD PRESSURE INCREASED156 reports
CONFUSIONAL STATE156 reports
GAIT DISTURBANCE156 reports
HYPOAESTHESIA156 reports
INJECTION SITE PAIN155 reports
PERIPHERAL SWELLING155 reports
CATARACT154 reports
TREMOR149 reports
HOSPITALISATION146 reports
INCORRECT DOSE ADMINISTERED144 reports
ABDOMINAL PAIN UPPER143 reports
DRUG HYPERSENSITIVITY141 reports
HYPOGLYCAEMIC UNCONSCIOUSNESS135 reports
MUSCLE SPASMS134 reports
RENAL FAILURE ACUTE127 reports
RENAL IMPAIRMENT127 reports
SOMNOLENCE127 reports
BLOOD GLUCOSE ABNORMAL124 reports
END STAGE RENAL DISEASE124 reports
ABDOMINAL DISCOMFORT122 reports
HAEMOGLOBIN DECREASED122 reports
DRUG DOSE OMISSION121 reports
CARDIAC DISORDER118 reports
HYPERSENSITIVITY118 reports
MEMORY IMPAIRMENT116 reports
GASTROINTESTINAL HAEMORRHAGE112 reports
CARDIAC FAILURE110 reports
PLATELET COUNT DECREASED110 reports
CORONARY ARTERY DISEASE109 reports
PRODUCT DOSE OMISSION ISSUE109 reports
PALPITATIONS108 reports
RENAL DISORDER107 reports
BLINDNESS104 reports
NASOPHARYNGITIS104 reports
ABDOMINAL DISTENSION102 reports
INJURY102 reports
RESPIRATORY FAILURE102 reports
CHEST DISCOMFORT101 reports

Report Outcomes

Out of 12,254 classified reports for HUMAN INSULIN:

Serious 68.2%Non-Serious 31.8%

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

Female6,150 (52.3%)
Male5,605 (47.6%)
Unknown11 (0.1%)

Reports by Age

Age 66271 reports
Age 65259 reports
Age 67248 reports
Age 70243 reports
Age 69230 reports
Age 68229 reports
Age 71221 reports
Age 73221 reports
Age 72216 reports
Age 63212 reports
Age 58206 reports
Age 62201 reports
Age 75195 reports
Age 64193 reports
Age 60188 reports
Age 61182 reports
Age 74182 reports
Age 56180 reports
Age 59179 reports
Age 77174 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 HUMAN INSULIN?

This profile reflects 24,125 FDA FAERS reports that mention HUMAN INSULIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HUMAN INSULIN?

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

Who manufactures HUMAN INSULIN?

Labeling and FAERS entries often list Novo Nordisk in connection with HUMAN INSULIN. 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.