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Darzalex Side Effects

Generic name: daratumumab

Medically reviewed by Drugs.com. Last updated on July 21, 2020.

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

Side effects requiring immediate medical attention

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

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chest pain or tightness
  • chills
  • confusion
  • cough
  • dizziness
  • ear congestion
  • facial swelling
  • fast heartbeat
  • fever
  • headache
  • loss of voice
  • nausea
  • nervousness
  • pounding in the ears
  • rapid, shallow breathing
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tingling of the hands or feet
  • trouble breathing
  • unusual weight gain or loss
  • vomiting

Less common

  • 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
  • tightness in the chest
  • unusual tiredness or weakness

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • 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

Side effects not requiring immediate medical attention

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
  • burning, numbness, tingling, or painful sensations
  • constipation
  • diarrhea
  • difficulty with moving
  • joint pain
  • loss of appetite
  • muscle pain or stiffness
  • pain in the arms or legs
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

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

Frequently asked questions

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.