What the label lists and what reports show
Daratumumab and hyaluronidase side effects
Daratumumab and hyaluronidase's FDA label: “The most common adverse reactions (≥20%) in patients with multiple myeloma eligible for autologous stem cell transplant who received DARZALEX FASPRO-VRd are peripheral neuropathy, fatigue, upper respiratory infection, constipation, musculoskeletal pain …” FAERS holds 2,880 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (218 reports).
- No generic listed
Check it at the source: the daratumumab and hyaluronidase FDA label on DailyMed (effective September 3, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DARZALEX FASPRO?DARZALEX FASPRO may cause serious reactions, including: Serious allergic reactions and other severe injection-related reactions. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX FASPRO. Your healthcare provider may temporarily stop or completely stop treatment with DARZALEX FASPRO if you have a serious reaction. […]
Source: FDA drug label, Janssen Biotech, Inc., effective September 3, 2026 (SPL set 4bb241af-4299-4373-8762-2d6709515db0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) in patients with multiple myeloma eligible for autologous stem cell transplant who received DARZALEX FASPRO-VRd are peripheral neuropathy, fatigue, upper respiratory infection, constipation, musculoskeletal pain, insomnia, rash, diarrhea, edema, and pyrexia.
Table 13: Adverse Reactions (≥10%) in Patients Who Received DARZALEX FASPRO with Bortezomib, Melphalan and Prednisone (DARZALEX FASPRO-VMP) in PLEIADES
| Reaction | Adverse Reaction All Grades (%) | DARZALEX FASPRO with Bortezomib, Melphalan and Prednisone (N=67) Grades ≥3 (%) |
|---|---|---|
| Upper respiratory tract infection Upper respiratory tract infection includes… | 39 | 0 |
| Bronchitis | 16 | 0 |
| Pneumonia Pneumonia includes lower respiratory tract infection, lung infection,… | 15 | 7 Only Grade 3 adverse reactions occurred. |
| Constipation | 37 | 0 |
| Nausea | 36 | 0 |
| Diarrhea | 33 | 3 |
| Vomiting | 21 | 0 |
| Abdominal pain Abdominal pain includes abdominal pain, and abdominal pain upper. | 13 | 0 |
| Fatigue Fatigue includes asthenia, and fatigue. | 36 | 3 |
| Pyrexia | 34 | 0 |
| Edema peripheral Edema peripheral includes edema, edema peripheral, and peripheral… | 13 | 1 |
| Peripheral sensory neuropathy | 34 | 1 |
| Dizziness | 10 | 0 |
| Cough Cough includes cough, and productive cough. | 24 | 0 |
| Insomnia | 22 | 3 |
| Back pain | 21 | 3 |
| Musculoskeletal chest pain | 12 | 0 |
| Decreased appetite | 15 | 1 |
| Rash | 13 | 0 |
| Pruritus | 12 | 0 |
| Hypertension | 13 | 6 |
| Hypotension | 10 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity and Other Administration Reactions [see Warnings and Precautions (5.1) ]. Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis [see Warnings and Precautions (5.2) ]. Infections [see Warnings and Precautions (5.3) ]. Neutropenia [see Warnings and Precautions (5.4) ]. Thrombocytopenia [see Warnings and Precautions (5.5) ]. The most common adverse reactions (≥20%) in patients with multiple myeloma eligible for autologous stem cell transplant who received DARZALEX FASPRO-VRd are peripheral neuropathy, fatigue, upper respiratory infection, constipation, musculoskeletal pain, insomnia, rash, diarrhea, edema, and pyrexia. ( 6.1 ) The most common adverse reactions (≥20%) in patients with multiple myeloma who were ineligible for autologous stem cell transplant who received DARZALEX FASPRO-VRd are upper respiratory tract infection, sensory neuropathy, musculoskeletal pain, diarrhea, fatigue, edema, rash, motor dysfunction, COVID-19, constipation, sleep disorder, cough, pneumonia, renal impairment, dizziness, nausea, urinary tract infection, pyrexia, abdominal pain, dyspnea, decreased appetite, and bruising. ( 6.1 ) The most common adverse reaction (≥20%) in patients with multiple myeloma who received DARZALEX FASPRO monotherapy is upper respiratory tract infection.
Source: FDA drug label, Janssen Biotech, Inc., effective September 3, 2026 (SPL set 4bb241af-4299-4373-8762-2d6709515db0), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,880 reports list daratumumab and hyaluronidase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 111 are coded as a death and 423 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Daratumumab and hyaluronidase: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions