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 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.

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:

More common side effects

• dark urine
• diarrhea
• loss of appetite
• nausea
• pain or tenderness in the upper stomach
• pale stools
• severe stomach pain
• vomiting
• yellow eyes or skin

Less common side effects

• black, tarry stools
• blood in the urine
• blurred vision
• bruising or purple areas on the skin
• chest pain or discomfort
• coughing up blood
• decreased alertness
• dizziness
• headache
• irregular heartbeat
• joint pain or swelling
• nervousness
• nosebleeds
• pain in the chest, groin, or legs, especially calves of the legs
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach swelling
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sweating
• trouble breathing

Incidence not known

• bleeding gums
• bloating
• chills
• cloudy urine
• constipation
• difficult or painful urination
• fast heartbeat
• fever
• indigestion
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• sudden increase or decrease in amount of urine
• swelling of face, feet, or lower legs
• unusual bleeding or bruising
• weight gain

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:

More common side effects

• weight loss

Less common side effects

• depression
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• muscle cramps and stiffness
• slow heartbeat
• unusual tiredness or weakness

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%)

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