Insulin isophane / insulin regular Side Effects
For the Consumer
Applies to insulin isophane / insulin regular: subcutaneous suspension, subcutaneous suspension pen-injector
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- Very bad irritation where the shot was given.
- Change in eyesight.
- Very bad dizziness or passing out.
- Mood changes.
- Slurred speech.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Change in skin to thick or thin where the shot was given.
- Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Weight gain.
- Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Hypersensitivity side effects have included both local and systemic reactions. Local reactions have presented as erythema, swelling, heat, or subcutaneous nodules. They usually occurred within the first two weeks of therapy and then disappear. Systemic allergy is a generalized allergy to insulin which may present as a rash over the whole body, shortness of breath, wheezing, drop in blood pressure, fast pulse, or sweating. Severe cases may be life-threatening.
There have been rare reports of patients with hypersensitivity reactions to human insulins who have tolerated insulins of animal origin.[Ref]
Uncommon (0.1% to 1%): Local reactions such as redness, swelling, or itching at the injection site
Very rare (less than 0.01%): Systemic reactions[Ref]
Frequency not reported: Peripheral edema[Ref]
Uncommon (0.1% to 1%): Lipodystrophy
Frequency not reported: Rash, pruritus[Ref]
Very common (10% or more): Hypoglycemia[Ref]
Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching, may occur. These reactions are usually transitory and may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.[Ref]
Frequency not reported: Injection site reactions[Ref]
Frequency not reported: Weight gain[Ref]
Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.[Ref]
Frequency not reported: Anti-insulin antibodies[Ref]
Frequency not reported: Acute painful neuropathy[Ref]
Fast improvement in blood glucose has been associated with acute painful neuropathy, which is generally reversible.[Ref]
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Humulin 70/30 (insulin isophane-insulin regular)." Lilly, Eli and Company, Indianapolis, IN.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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