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]
