Active substance
Somatropin recombinant
- US FDA 2
- Safety 10
US FDA United States — FDA approvals (Drugs@FDA)
Safety signals and safety-related labeling changes
- US FDA 14 Jul 2026 SEROSTIM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Nov 2025 HUMATROPE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Jul 2025 NORDITROPIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Jul 2025 GENOTROPIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 9 Jul 2025 NUTROPIN AQ — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions - US FDA 9 Jul 2025 OMNITROPE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 9 Jul 2025 ZOMACTON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 17 Jan 2017 SAIZEN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Dec 2016 ACCRETROPIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions - US FDA 13 Dec 2016 NUTROPIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.