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Common side effects

In the clinical study, most of the 1400 participants who took NERLYNX experienced diarrhea. In addition to diarrhea, other side effects commonly experienced included:

  • nausea

  • stomach-area (abdomen) pain

  • tiredness

  • vomiting

  • rash

  • dry or inflamed mouth, or mouth sores

  • decreased appetite

  • muscle spasms

  • upset stomach

  • nail problems including color change

  • dry skin

  • swelling of your stomach-area

  • weight loss

  • urinary tract infection

There are ways to manage the potential side effects of NERLYNX, so don’t let them discourage you. And don’t be afraid to talk to your doctor or nurse about how to manage side effects. Your doctor can prescribe medication or adjust the dose. Your doctor can also tell you about over-the-counter medicines that can help.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about NERLYNX (ner links)?

NERLYNX (neratinib) may cause serious side effects, including:

  • Diarrhea. Diarrhea is a common side effect of NERLYNX, but it can also be severe. You may lose too much body salts and fluids, and get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 months (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:

See "What are the possible side effects of NERLYNX?" for more information about side effects.

What is NERLYNX?

NERLYNX is a prescription medicine used to treat adults who have early-stage breast cancer, which:

It is not known if NERLYNX is safe and effective in children.

Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs, and H-2 receptor antagonists. You should avoid taking these medicines during treatment with NERLYNX.

What are the possible side effects of NERLYNX?

NERLYNX may cause serious side effects, including:
See "What is the most important information I should know about NERLYNX?"

Common side effects of NERLYNX include:

These are not all the possible side effects of NERLYNX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Patient Information, please click here.