nintedanib

• Risk factors: History of liver problems | Low body weight (less than 143 lbs) | Asian ancestry | Female | Older age

Ofev (nintedanib) can cause liver problems, including serious liver injury. These issues usually appear within the first 3 months of starting treatment. Your risk might be higher if you're female, Asian, an older adult, or weigh less than 143 pounds (65 kg). You’ll need blood tests before and during treatment to make sure your liver is working properly. Tell your care team right away if you feel very tired, lose your appetite, have pain in the upper right part of your stomach, dark urine, or yellowing of your skin or eyes.

If you have mild liver problems, your prescriber will likely give you a lower dose of Ofev (nintedanib). But this medication isn't recommended if you have moderate or severe liver problems.

Diarrhea is the most common side effect of Ofev (nintedanib). In studies, more than half of the people who took the medication had diarrhea, usually within the first 3 months of treatment. Most cases were mild or moderate. If you get diarrhea, let your care team know. They might recommend drinking more fluids and taking antidiarrheal medication like loperamide.

Nausea and vomiting are also common side effects of Ofev (nintedanib). These symptoms were usually mild or moderate in studies. If you feel nauseous or start vomiting, let your care team know. They might suggest antinausea medication, or lower your dose or pause treatment if needed.

Ofev (nintedanib) can cause serious harm or even death to an unborn baby if taken during pregnancy. If you can get pregnant, you'll need a pregnancy test before starting treatment and must use birth control during treatment and for at least 3 months after your last dose.

While Ofev (nintedanib) doesn't affect how well birth control pills work, it can cause vomiting or diarrhea. These side effects might make it harder for your body to absorb birth control pills, which raises the risk of pregnancy. If you experience vomiting or diarrhea, talk to your prescriber about using alternative birth control.

• Risk factors: Coronary artery disease (CAD)

Although rare, Ofev (nintedanib) raises your risk for blood clots, including heart attacks. Your risk is higher if you have coronary artery disease. Tell your care team right away if you have chest pain, shortness of breath, or other signs of a heart problem. If these symptoms happen, your prescriber might pause or stop your treatment.

• Risk factors: History of bleeding problems | Taking blood thinners

Ofev (nintedanib) can raise your risk of bleeding. If you have a history of bleeding problems or are taking blood thinners, use this medication carefully. Let your care team know right away if you notice unusual bleeding or bruising during treatment.

• Risk factors: Recent stomach surgery | Diverticulitis | Taking corticosteroids or NSAIDs

Although rare, Ofev (nintedanib) can raise your risk of a serious condition called gastrointestinal perforation, which is when a hole forms in the stomach or intestines. Your risk is higher if you've had recent stomach surgery, a history of diverticulitis, or if you're also taking corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs). If you develop severe stomach pain, fever, or notice blood in your stool, tell your care team right away.

Some people taking Ofev (nintedanib) have developed very high levels of protein in their urine, known as proteinuria, which can be a sign of kidney problems. If your care team notices new or worsening protein in your urine, they might pause your treatment to help protect your kidneys.