Imfinzi Side Effects

Generic Name: durvalumab

Note: This document contains side effect information about durvalumab. Some of the dosage forms listed on this page may not apply to the brand name Imfinzi.

For the Consumer

Applies to durvalumab: intravenous solution

Along with its needed effects, durvalumab (the active ingredient contained in Imfinzi) 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 or nurse immediately if any of the following side effects occur while taking durvalumab:

More common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• depressed mood
• difficult, burning, or painful urination
• difficulty having a bowel movement
• dry skin and hair
• feeling cold
• fever
• frequent urge to urinate
• hair loss
• hoarseness or husky voice
• lower back or side pain
• muscle cramps and stiffness
• pain
• rapid weight gain
• slowed heartbeat
• stomach cramps
• tenderness
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• watery or bloody diarrhea

Less common

• Chest pain
• chills
• cough
• dark urine
• difficult breathing
• general feeling of discomfort or illness
• general tiredness and weakness
• light-colored stools
• nausea
• nervousness
• sensitivity to heat
• sweating
• thickening of bronchial secretions
• trouble sleeping
• upper right abdominal or stomach pain
• vomiting
• weight loss
• yellow eyes and skin

Less common or rare

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• bloody nose
• blurred vision or other changes in vision
• chest tightness
• eye redness, irritation, or pain
• general body swelling
• headache
• heavier menstrual periods
• loss of appetite
• nosebleeds
• pale skin
• pinpoint red spots on the skin
• redness of the eye
• sensitivity of the eye to light
• skin rash
• sore throat
• stiff neck or back
• tearing
• unusual bleeding or bruising

Rare

• Dizziness
• drowsiness
• fainting

Some side effects of durvalumab 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:

Less common

• Decreased appetite
• muscle or joint pain

For Healthcare Professionals

Applies to durvalumab: intravenous solution

Endocrine

Common (1% to 10%): Immune-mediated endocrinopathies (e.g., hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis/hypopituitarism)^[Ref]

Dermatologic

Very common (10% or more): Rash (dermatitis, dermatitis acneiform, dermatitis psoriasiform, psoriasis, rash maculopapular, rash pruritic, rash papular, rash pustular, skin toxicity, eczema, erythema, erythema multiforme, rash erythematous, acne, lichen planus) (11%)^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Immune-related myocarditis^[Ref]

Hematologic

Very common (10% or more): Lymphopenia (11%)
Common (1% to 10%): Anemia^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (e.g., cystitis, candiduria, urosepsis) (15%)^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (21%), nausea (16%), abdominal pain (upper, lower, flank) (14%), diarrhea/colitis (13%)
Common (1% to 10%): Dehydration
Frequency not reported: Immune-mediated colitis^[Ref]

Hepatic

Common (1% to 10%): Liver injury, immune-mediated hepatitis
Uncommon (0.1% to 1%): Increased ASO, increased ALT, hyperbilirubinemia
Frequency not reported: Immune-mediated hepatitis^[Ref]

Metabolic

Very common (10% or more): Decreased appetite/hypophagia (19%), hyponatremia (12%)
Common (1% to 10%): Deterioration of general physical health, increased alkaline phosphatase, hypermagnesemia, hypercalcemia, hyperglycemia, neutropenia, hyperkalemia, hypoalbuminemia^[Ref]

Local

Common (1% to 10%): Infusion-related reactions^[Ref]

Immunologic

Common (1% to 10%): Infections (e.g., sepsis, necrotizing fasciitis, osteomyelitis)^[Ref]

Ocular

Uncommon (0.1% to 1%): Uveitis and keratitis^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., back pain, musculoskeletal chest pain, musculoskeletal pain and discomfort, myalgia, neck pain) (24%)^[Ref]

Nervous system

Common (1% to 10%): Pyrexia/tumor associated fever
Uncommon (0.1% to 1%): Immune-related aseptic meningitis^[Ref]

Other

Very common (10% or more): Fatigue (e.g., asthenia, lethargy, malaise) (39%), peripheral edema (e.g., edema, localized edema, edema peripheral, lymphedema, peripheral swelling, scrotal edema, scrotal swelling) (15%), pyrexia/tumor associated fever (14%)
Common (1% to 10%): Embryofetal toxicity^[Ref]

Renal

Common (1% to 10%): Acute kidney injury, increased creatinine^[Ref]

Respiratory

Very common (10% or more): Dyspnea/exertional dyspnea (24%), cough/productive cough (10%)
Uncommon (0.1% to 1%): Immune-mediated pneumonitis^[Ref]

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