Drug Landscape ›
LANTUS insulin ›
Regulatory · United States
Marketing authorisation
FDA
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: 20 April 2025 – 20 April 2026
Total reports: 591
Most-reported reactions
Blood Glucose Increased — 104 reports (17.6%) Nausea — 84 reports (14.21%) Diarrhoea — 63 reports (10.66%) Fatigue — 58 reports (9.81%) Renal Failure Acute — 52 reports (8.8%) Blood Glucose Decreased — 50 reports (8.46%) Dyspnoea — 50 reports (8.46%) Dizziness — 45 reports (7.61%) Vomiting — 43 reports (7.28%) Weight Decreased — 42 reports (7.11%)
Source database →
LANTUS insulin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is LANTUS insulin approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for LANTUS insulin in United States?
Merck Sharp & Dohme LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.