What the label lists and what reports show
Tafasitamab side effects
Tafasitamab's FDA label: “The most common adverse reactions (≥20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.” FAERS holds 898 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 neutropenia (39 reports).
- No generic listed
Check it at the source: the tafasitamab FDA label on DailyMed (effective February 2, 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 MONJUVI?MONJUVI may cause serious side effects, including: Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI. Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding. Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. […]
Source: FDA drug label, Incyte Corporation, effective February 2, 2026 (SPL set ec13ac6b-bfde-4e84-907a-83bd69584d95), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.
Table 3: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Received MONJUVI in L-MIND
| Reaction | Adverse Reaction All Grades (%) | MONJUVI (N=81) Grade 3 or 4 (%) |
|---|---|---|
| Neutropenia | 51 | 49 |
| Anemia | 36 | 7 |
| Thrombocytopenia | 31 | 17 |
| Febrile neutropenia | 12 | 12 |
| Fatigue Fatigue includes asthenia and fatigue | 38 | 3.7 |
| Pyrexia | 24 | 1.2 |
| Peripheral edema | 24 | 0 |
| Diarrhea | 36 | 1.2 |
| Constipation | 17 | 0 |
| Abdominal pain Abdominal pain includes abdominal pain, abdominal pain lower, and… | 15 | 1.2 |
| Nausea | 15 | 0 |
| Vomiting | 15 | 0 |
| Cough | 26 | 1.2 |
| Dyspnea | 12 | 1.2 |
| Respiratory tract infection Respiratory tract infection includes: lower respiratory tract… | 24 | 4.9 |
| Urinary tract infection Urinary tract infection includes: urinary tract infection,… | 17 | 4.9 |
| Bronchitis | 16 | 1.2 |
| Decreased appetite | 22 | 0 |
| Hypokalemia | 19 | 6 |
| Back pain | 19 | 2.5 |
| Muscle spasms | 15 | 0 |
| Rash Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous , rash… | 15 | 2.5 |
| Pruritus | 10 | 1.2 |
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: Infusion-related reactions [see Warnings and Precautions (5.1) ] Myelosuppression [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MORPHOSYS US INC. at 1-844-667-1992 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory Diffuse Large B-Cell Lymphoma The safety of MONJUVI was evaluated in L-MIND [see Clinical Studies (14) ]. Patients (n=81) received MONJUVI 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle; Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle; …
Source: FDA drug label, Incyte Corporation, effective February 2, 2026 (SPL set ec13ac6b-bfde-4e84-907a-83bd69584d95), via openFDA; the full label on DailyMed
What do FAERS reports show?
898 reports list tafasitamab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 130 are coded as a death and 143 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 18 reactions below, 9 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?
- Tafasitamab: 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