What the label lists and what reports show
Glofitamab side effects
Glofitamab's FDA label: “The most common (≥ 20%) adverse reactions, excluding laboratory abnormalities, are cytokine release syndrome, musculoskeletal pain, rash, and fatigue.” FAERS holds 2,383 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 cytokine release syndrome (747 reports).
- No generic listed
- Boxed warning
Check it at the source: the glofitamab FDA label on DailyMed (effective June 25, 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 COLUMVI?COLUMVI can cause serious side effects, including: See " What is the most important information I should know about COLUMVI? " Neurologic problems. COLUMVI can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with COLUMVI. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: headache confusion and disorientation difficulty paying attention or understanding things trouble speaking sleepiness memory problems numbness, tingling, or weakness of the hands or feet dizziness shaking (tremors) Serious infections. COLUMVI can cause serious infections that may lead to death. […]
Source: FDA drug label, Genentech, Inc., effective June 25, 2026 (SPL set 3516e753-f064-4d30-9bd5-e3f2e143f75d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥ 20%) adverse reactions, excluding laboratory abnormalities, are cytokine release syndrome, musculoskeletal pain, rash, and fatigue.
Table 9: Select Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory LBCL Who Received COLUMVI in Study NP30179
| Reaction | Adverse Reactions All grades (%) | COLUMVI N=145 Grade 3 or 4 (%) |
|---|---|---|
| Cytokine release syndrome | 70 | 4.1 |
| Musculoskeletal pain Includes musculoskeletal pain, back pain, bone pain, flank pain,… | 21 | 2.1 |
| Fatigue Includes fatigue and asthenia. | 20 | 1.4 |
| Pyrexia | 16 | 0 |
| Edema Includes edema, edema peripheral, swelling face, and face edema. | 10 | 0 |
| Rash Includes rash, rash pruritic, rash maculo-papular, dermatitis, dermatitis acneiform,… | 20 | 1.4 |
| Constipation | 14 | 0 |
| Diarrhea | 14 | 0 |
| Nausea | 10 | 0 |
| Abdominal pain Includes abdominal pain, abdominal discomfort, and abdominal pain upper. | 10 | 0 |
| Tumor flare | 12 | 2.8 |
| Headache | 10 | 0 |
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: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity [see Warnings and Precautions (5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Tumor Flare [see Warnings and Precautions (5.4) ] The most common (≥ 20%) adverse reactions, excluding laboratory abnormalities, are cytokine release syndrome, musculoskeletal pain, rash, and fatigue. The most common (≥ 20%) Grade 3 to 4 laboratory abnormalities are lymphocyte count decreased, phosphate decreased, neutrophil count decreased, uric acid increased, and fibrinogen decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Genentech, Inc., effective June 25, 2026 (SPL set 3516e753-f064-4d30-9bd5-e3f2e143f75d), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,383 reports list glofitamab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 722 are coded as a death and 776 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 19 reactions below, 10 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?
- Glofitamab: 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