Ofev Side Effects

Generic name: nintedanib

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

Note: This document contains side effect information about nintedanib. Some dosage forms listed on this page may not apply 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

• 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

• 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

• Weight loss

Less common

• 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

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 long does it take for Ofev to start working?
• Why does Ofev cause diarrhea?
• Can Ofev and Esbriet be given together?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer