FDA label ab4bf7e1-4e30-4c7d-9f0a-37b96ca7ca75

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
335f8c6b-8291-46a5-9967-f0ba6092bf3d
SPL ID
ab4bf7e1-4e30-4c7d-9f0a-37b96ca7ca75
Version
1
Effective date
2012-01-11
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:27

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING Any change of insulin dose should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g. regular, NPH, analog, etc.), species (animal, human), or method of manufacture (rDNA versus animal-source insulin) may result in the need for a change in dosage. Special care should be taken when the transfer is from a standard beef or mixed species insulin to a purified pork or human insulin. If a dosage adjustment is needed, it will usually become apparent either in the first few days or over a period of several weeks. Any change in treatment should be carefully monitored.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse events commonly associated with human insulin therapy include the following: Body as Whole - Allergic reactions (see PRECAUTIONS, Allergy ). Skin and Appendages - Injection site reaction, lipodystrophy, pruritus, rash (see PRECAUTIONS, Allergy ). Other - Hypoglycemia, Hyperglycemia and ketosis (see PRECAUTIONS ).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.