Darzalex Side Effects

Generic name: daratumumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 3, 2023.

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

Applies to daratumumab: intravenous solution.

Serious side effects of Darzalex

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
difficulty swallowing
dizziness
ear congestion
facial swelling
fast heartbeat
fever
headache
hoarseness
loss of voice
nausea
nervousness
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, lips, or tongue
rapid, shallow breathing
skin rash, hives, or itching
slow or fast heartbeat
sneezing
sore throat
stuffy or runny nose
tingling of the hands or feet
trouble breathing
unusual tiredness or weakness
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
sweating

Incidence not known

Black, tarry stools
bleeding gums
blood in the urine or stools
constipation
coughing that sometimes produce a pink frothy sputum
darkened urine
lower back or side pain
pains in the stomach, side, or abdomen, possibly radiating to the back
painful or difficult urination
pale skin
pinpoint red spots on the skin
swelling in the legs and ankles
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
yellow eyes or skin

Other side effects of Darzalex

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
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]