🇺🇸 Humalog in United States

87,277 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 28 March 2025 – 28 March 2026
• Total reports: 87,277

Most-reported reactions

1. Blood Glucose Increased — 37,649 reports (43.14%)
2. Blood Glucose Decreased — 8,865 reports (10.16%)
3. Incorrect Dose Administered — 8,595 reports (9.85%)
4. Drug Ineffective — 7,704 reports (8.83%)
5. Visual Impairment — 5,027 reports (5.76%)
6. Nausea — 4,580 reports (5.25%)
7. Malaise — 3,925 reports (4.5%)
8. Drug Dose Omission — 3,850 reports (4.41%)
9. Fatigue — 3,574 reports (4.1%)
10. Hypoglycaemia — 3,508 reports (4.02%)

Source database →

Frequently asked questions

Is Humalog approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Humalog in United States?

Halozyme Therapeutics is the originator. The local marketing authorisation holder may differ — check the official source linked above.