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Durvalumab Side Effects

For the Consumer

Applies to durvalumab: intravenous solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of thyroid, pituitary, or adrenal gland problems. Some signs may be change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Any unexplained bruising or bleeding.
  • Very bad muscle pain or weakness.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Chest pain.
  • A heartbeat that does not feel normal.
  • Feeling very tired or weak.
  • Swelling in the arms or legs.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling tired or weak.
  • Muscle pain.
  • Bone pain.
  • Hard stools (constipation).
  • Not hungry.
  • Upset stomach.
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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]

References

1. "Product Information. Imfinzi (durvalumab)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Some side effects of durvalumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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