Safety and
Side Effects

Home Take OFEV Safety and Side Effects

It helps to know what side effects you may experience when you start taking a new medication. If you experience side effects, speak with your doctor right away.

safety and side effects
of ofev

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

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

Your doctor may adjust your OFEV dose to manage your side effects by either:

  • Reducing the dose of OFEV you are taking
  • Briefly stopping your OFEV treatment and then restarting it if your symptoms get better, either at a lower dose or the same dose you were taking
  • Discontinuing your treatment entirely if symptoms do not get better while taking OFEV at a lower dose

Quick Tip: 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.

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 regularly to check how well your liver function is working 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 1 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.

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 https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

Tips to help treat
diarrhea, nausea, and vomiting

In medical studies, 62% of patients taking OFEV experienced diarrhea compared to 18% of patients not taking OFEV. Most of these events were mild to moderate in intensity and occured within the first 3 months of treatment. The majority of patients who had diarrhea in these studies were able to remain on treatment with OFEV. Diarrhea led to discontinuation of OFEV in 5% of patients.

What You Can Do

Stay Hydrated
  • Stay hydrated
  • Ask your doctor about medication that may treat diarrhea

Dietary Changes May Help

Dietary Changes
  • Ask your doctor if you should try the B.R.A.T. diet (Bananas Rice Applesauce and Toast) that may help with diarrhea
  • Check with your doctor how long to try the B.R.A.T. diet since its goal is to ease you back to normal foods that provide a more rounded, healthy diet
  • Be sure to tell your doctor if the diarrhea symptoms do not go away or become worse. Your doctor may need to reduce your dose, stop your OFEV until your diarrhea gets better, and—in severe cases—stop your OFEV permanently

In medical studies, 24% of patients taking OFEV experienced nausea compared to 7% of patients not taking OFEV. Vomiting was reported in 12% taking OFEV versus 3% not taking OFEV. The majority of patients who had nausea and vomiting in these studies were able to remain on treatment with OFEV. Nausea led to discontinuation in 2% of patients and vomiting led to discontinuation in 1% of patients.

When you have nausea or vomiting, it's important that you drink plenty of fluids. it also helps to eat certain foods that are easy on your stomach, and avoid others that can make your symptoms worse. Here are a few helpful tips about what you should eat or drink and what you should avoid:

Fluids

Drink Fluids
  • Water or sports drinks with electrolytes
  • Clear soda such as ginger ale
  • Cranberry or grape juice
  • Tea

Fruits and Sweets

Eat Healthy
  • Bananas or canned fruit such as applesauce, peaches, or pears
  • Gelatin (Jell-O®)
  • Popsicles® or sherbet
  • Yogurt (plain or vanilla)

Meals and Snacks

Types of Meals
  • 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

Don't Eat

Foods to Avoid
  • Spicy foods
  • Fried or greasy foods
  • Salty or sweet food

Be sure to tell your doctor if your vomiting or nausea does not go away or becomes worse.