What side effects may occur with nintedanib?

In 2019, nintedanib became the first therapy approved by the FDA to slow the rate of lung function decline in adults with SSc-ILD.

What side effects may occur with nintedanib?

The following are not all possible side effects of nintedanib. For more information, consult your doctor or pharmacist.

Stroke: If you experience stroke symptoms, inform your doctor immediately. These symptoms may include numbness or weakness on one side of the body, difficulty speaking, headache or dizziness.

Bleeding problems: Nintedanib may increase the risk of bleeding problems. Inform your doctor if you have unusual bleeding, bruising or delayed wound healing. Tell your doctor if you are taking anticoagulants (blood thinners), including prescription anticoagulants and over-the-counter aspirin.

Perforation of the stomach or intestinal wall: Nintedanib may increase the risk of stomach or intestinal wall perforation. Inform your doctor if you have abdominal pain or swelling.

Increased protein in urine (proteinuria): Nintedanib may increase the risk of proteinuria. Inform your doctor if you experience any signs or symptoms of proteinuria, such as foamy urine, swelling of the hands, arms, legs or feet, or sudden weight gain.

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

Serious side effects of nintedanib

Nintedanib may cause serious side effects, including:

Liver problems: If you experience unexplained symptoms such as yellowing of the skin or the whites of the eyes (jaundice), dark or brown urine (tea-colored urine), pain in the upper right abdomen, increased bleeding or bruising, unusual tiredness or loss of appetite, call your doctor immediately. Your doctor will perform blood tests to monitor liver function before and during nintedanib treatment.

Diarrhea, nausea and vomiting: During nintedanib treatment, your doctor may recommend drinking plenty of water or taking medication to manage these side effects. Inform your doctor if you have diarrhea, nausea or vomiting, or if these symptoms persist or worsen. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medications or dietary supplements that may cause diarrhea.

Heart attack: If you experience heart attack symptoms, inform your doctor immediately. These symptoms may include chest pain or pressure, pain in the arm, back, neck or jaw, or shortness of breath.