FDA — authorised 14 June 1996
- Application: BLA020563
- Marketing authorisation holder: LILLY
- Local brand name: HUMALOG KWIKPEN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Humalog Kwikpen in United States
FDA authorised Humalog Kwikpen on 14 June 1996 · 3,494 US adverse-event reports
Marketing authorisations
FDA — authorised 26 May 2015
- Application: BLA205747
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: HUMALOG KWIKPEN
- Indication: SOLUTION — SUBCUTANEOUS
- 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: 22 April 2025 – 22 April 2026
- Total reports: 3,494
Most-reported reactions
- Blood Glucose Increased — 1,446 reports (41.39%)
- Incorrect Dose Administered — 529 reports (15.14%)
- Visual Impairment — 265 reports (7.58%)
- Blood Glucose Decreased — 260 reports (7.44%)
- Wrong Technique In Product Usage Process — 251 reports (7.18%)
- Drug Ineffective — 198 reports (5.67%)
- Glycosylated Haemoglobin Increased — 154 reports (4.41%)
- Accidental Underdose — 143 reports (4.09%)
- Blood Glucose Abnormal — 127 reports (3.63%)
- Product Dose Omission Issue — 121 reports (3.46%)
Other Diabetes approved in United States
Frequently asked questions
Is Humalog Kwikpen approved in United States?
Yes. FDA authorised it on 14 June 1996; FDA authorised it on 26 May 2015.
Who is the marketing authorisation holder for Humalog Kwikpen in United States?
LILLY holds the US marketing authorisation.