Ofev Side Effects

Generic name: nintedanib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 22, 2023.

Note: This document provides detailed information about Ofev.

Applies to nintedanib: oral capsule Side Effects associated with nintedanib. Some dosage forms listed on this page may not apply specifically to the brand name Ofev.

Applies to nintedanib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women will receive a pregnancy test before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause stomach or bowel problems, including nausea, vomiting, or diarrhea, and in some cases it can be severe. Do not take any medicines without first checking with your doctor. If mild nausea, vomiting, or diarrhea continues or gets worse, check with your doctor right away.

This medicine may increase your risk of bleeding, or your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort, dizziness, headache, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or unusual bleeding or bruising.

This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have severe stomach pain that does not go away or blood in the stool.

Check with your doctor right away if you have cloudy urine, swelling in your hands, arms, legs, or feet, or weight gain. These may be symptoms of proteinuria (increased protein in the urine).

This medicine could cause infertility in women. Talk with your doctor before using this medicine if you plan to have children.

Stop smoking before treatment with Ofev® and avoid smoking while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Ofev

Along with its needed effects, nintedanib (the active ingredient contained in Ofev) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nintedanib:

Other side effects of Ofev

Some side effects of nintedanib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to nintedanib: oral capsule.

General adverse events

The most common adverse reactions (incidence greater than 5%) included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and hypertension.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, arterial thromboembolic events, venous thromboembolism
• Uncommon (0.1% to 1%): Myocardial infarction
• Frequency not reported: Aneurysms and artery dissections

Dermatologic

• Very common (10% or more): Skin ulcer (18%)
• Common (1% to 10%): Alopecia, rash
• Uncommon (0.1% to 1%): Pruritus

Endocrine

• Common (1% to 10%): Hypothyroidism

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 76%), nausea (up to 32%), vomiting (up to 25%), abdominal/esophageal pain (up to 18%), mucositis
• Common (1% to 10%): Constipation
• Uncommon (0.1% to 1%): Pancreatitis, colitis
• Postmarketing reports: Gastrointestinal perforation

Hematologic

• Very common (10% or more): Neutropenia (up to 13.8%), decreased hemoglobin (up to 11.2%)
• Common (1% to 10%): Bleeding, febrile neutropenia
• Uncommon (0.1% to 1%): Thrombocytopenia
• Postmarketing reports: Bleeding events

Hepatic

• Very common (10% or more): Liver enzyme elevation (up to 14%), increased ALT
• Common (1% to 10%): Hyperbilirubinemia, increased ALT, increased GGT, increased blood alkaline phosphatase
• Uncommon (0.1% to 1%): Drug induced liver injury

Metabolic

• Very common (10% or more): Electrolyte imbalance
• Uncommon (0.1% to 1%): Dehydration

Musculoskeletal

• Common (1% to 10%): Back pain

Nervous system

• Very common (10% or more): Peripheral neuropathy
• Common (1% to 10%): Headache, dizziness

Other

• Very common (10% or more): Decreased weight (up to 12%), fatigue (up to 11%), Decreased appetite (up to 11%)
• Common (1% to 10%): Pyrexia, sepsis, abscesses

Renal

• Uncommon (0.1% to 1%): Renal failure
• Postmarketing reports: Proteinuria

Respiratory

• Very common (10% or more): Cough (up to 15.2%)

See also:

Frequently asked questions

• What food should I avoid while taking Ofev?
• How effective is Ofev for pulmonary fibrosis?
• How long does it take for Ofev to start working?
• Why does Ofev cause diarrhea?
• Can Ofev and Esbriet be given together?

Further information

Ofev side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer