Safety and
Side Effects

Before starting any treatment, it's important to understand its potential benefits as well as the possible risks. Take a closer look at some of the side effects OFEV® (nintedanib) capsules may cause, plus a few tips that may help manage them. And, of course, if you experience any side effects, speak to your doctor right away. Your doctor will want to know how you’re feeling—as well as how you are tolerating your medication—and can make adjustments as needed.

OFEV is the only twice-daily pill approved to:

  • treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
  • treat adults with a long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
  • slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).

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

On This Page

Safety and Side Effects of
OFEV

OFEV may cause serious side effects, including liver problems, diarrhea, nausea, vomiting, heart attack, stroke, bleeding problems, a tear in your stomach or intestinal wall (perforation), and increased protein in your urine (proteinuria).

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

Serious Side Effects

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver function is working before starting and during your treatment with OFEV.
While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat diarrhea. Tell your doctor if you have diarrhea or if it does not go away or becomes worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea.
While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have nausea or vomiting, or if your nausea or vomiting does not go away or becomes worse.
Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

UNDERSTANDING GASTROINTESTINAL
SIDE EFFECTS

Diarrhea was the most common adverse event occurring in all OFEV medical studies:

  • Mild to moderate in 9 out of 10 patients
  • Occurred most frequently in the first 3 months of treatment

REPORTED DIARRHEA FROM MEDICAL STUDIES

Diarrhea occurred in:

  • 62% of IPF patients treated with OFEV and 18% of patients not taking OFEV; it led to discontinuation in 5% of OFEV patients compared to <1% of those not taking OFEV
  • 67% of patients with chronic ILDs with worsening fibrosis treated with OFEV and 24% of patients not taking OFEV; it led to discontinuation in 6% of OFEV patients compared to <1% of those not taking OFEV
  • 76% of patients with scleroderma-associated ILD treated with OFEV and 32% of patients not taking OFEV; it led to discontinuation in 7% of OFEV patients compared to <1% of those not taking OFEV

Discontinuation means that the patients in the studies stopped taking treatment.

NAUSEA AND VOMITING ARE COMMON SIDE EFFECTS

Nausea occurred in:

  • 24% of IPF patients treated with OFEV capsules and 7% of patients not taking OFEV; it led to discontinuation in 2% of OFEV patients compared to 0% of those not taking OFEV
  • 29% of patients with chronic ILDs with worsening fibrosis treated with OFEV and 9% of patients not taking OFEV; it led to discontinuation in <1% of OFEV patients
  • 32% of scleroderma-associated ILD patients treated with OFEV and 14% of patients not taking OFEV; it led to discontinuation in 2% of OFEV patients compared to 0% of those not taking OFEV

Vomiting occurred in:

  • 12% of IPF patients treated with OFEV and 3% of patients not taking OFEV; it led to discontinuation in 1% of OFEV patients compared to 0% of those not taking OFEV
  • 18% of patients with chronic ILDs with worsening fibrosis treated with OFEV and 5% of patients not taking OFEV; it led to discontinuation in 1% of OFEV patients
  • 25% of scleroderma-associated ILD patients treated with OFEV and 10% of patients not taking OFEV; it led to discontinuation in 1% of OFEV patients compared to 0.3% of those not taking OFEV

Discontinuation means that the patients in the studies stopped taking treatment.

TIPS TO HELP MANAGE
COMMON SIDE EFFECTS

Should you experience diarrhea, nausea, or vomiting, it is important that you drink plenty of fluids to prevent dehydration. It also helps to eat certain foods that are easy on your stomach, and avoid others that can make your symptoms worse.

Be sure to tell your doctor about any symptoms and if they do not go away or become worse.

Quick Fact: Your doctor may recommend over-the-counter medicines to treat diarrhea. These include loperamide, available by brand names Imodium® and Imodium A-D®.

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Dietary Changes May Help

  • Ask your doctor if you should try the B.R.A.T. (Bananas, Rice, Applesauce, and Toast) diet that may help with diarrhea
  • Check with your doctor about remaining on the B.R.A.T. diet since its goal is to ease you back to normal foods that provide a more rounded, healthy diet

Dietary Choices to Consider

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Fluids to Prevent Dehydration

  • Water
  • Sports drinks with electrolytes
  • Clear soda such as ginger ale
  • Cranberry or grape juice
  • Clear, decaffeinated tea
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Fruits and Sweets

  • Bananas or canned fruit such as applesauce, peaches, or pears
  • Gelatin (Jell-O®)
  • Popsicles® or sherbet
  • Yogurt
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Meals and Snacks

  • Broiled or baked (not fried) chicken without the skin
  • Clear chicken, beef, or vegetable broth
  • Farina or oatmeal
  • Pasta or white rice
  • White toast, crackers, or pretzels
  • Peeled potatoes, boiled
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Foods to Avoid

  • Spicy foods
  • Fried or greasy foods

MANAGING SIDE EFFECTS
WITH YOUR HEALTHCARE TEAM

If your side effects get worse or do not go away, your doctor may:

  • Reduce the dose of OFEV you are taking
  • Briefly stop your OFEV treatment until the symptoms of your side effects improve
  • Restart your OFEV treatment if your symptoms get better, either at a lower dose or the same dose you were taking
  • Discontinue your treatment entirely if symptoms do not get better

Remember: Only your doctor should change your dose. Take OFEV exactly as your doctor tells you to take it. Your doctor will tell you how much OFEV to take and when to take it.

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