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Darzalex Side Effects

Generic Name: daratumumab

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

For the Consumer

Applies to daratumumab: intravenous solution

Along with its needed effects, daratumumab (the active ingredient contained in Darzalex) 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 daratumumab:

More common
  • Blurred vision
  • body aches or pain
  • chest pain or tightness
  • dizziness
  • ear congestion
  • fever or chills
  • facial swelling
  • headache
  • loss of voice
  • nausea or vomiting
  • nervousness
  • pounding in the ears
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • trouble breathing
Less common
  • Confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • painful blisters on the trunk of body
  • skin rash, hives, or itching
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • cough
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising

Some side effects of daratumumab 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
  • Back pain
  • constipation
  • diarrhea
  • difficulty with moving
  • joint pain
  • loss of appetite
  • muscle pain or stiffness
  • pain in the arms or legs

For Healthcare Professionals

Applies to daratumumab: intravenous solution

Cardiovascular

Very common (10% or more): Hypertension (10%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (27%), diarrhea (16%), constipation (15%), vomiting (14%)[Ref]

Hematologic

Very common (10% or more): Lymphopenia (72%), neutropenia (60%), thrombocytopenia (48%), anemia (45%)[Ref]

Immunologic

Common (1% to 10%): Pneumonia (e.g., streptococcal pneumonia, lobar pneumonia), herpes zoster reactivation[Ref]

Local

Very common (10% or more): Infusion reaction (48%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (15%)[Ref]

Musculoskeletal

Very common (10% or more): Back pain (23%), arthralgia (17%), pain in extremity (15%), musculoskeletal chest pain (12%)[Ref]

Nervous system

Very common (10% or more): Headache (12%)[Ref]

Respiratory

Very common (10% or more): Cough (21%), upper respiratory tract infection (20%), nasal congestion (17%), dyspnea (15%), nasopharyngitis (15%), vomiting (14%)
Common (1% to 10%): Bronchospasm, dyspnea, hypoxia
Uncommon (0.1% to 1%): Allergic rhinitis allergic, throat irritation[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Darzalex (daratumumab)." Janssen Biotech, Inc., Horsham, PA, PA.

Some side effects of Darzalex 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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