What the label lists and what reports show
Ocrelizumab side effects
Ocrelizumab's FDA label: “The most common adverse reactions were: RMS (incidence ≥10% and > REBIF ® ): upper respiratory tract infections and infusion reactions ( 6.1 ) PPMS (incidence ≥10% and > placebo): upper respiratory tract infections, infusion reactions, skin infections, and …” FAERS holds 61,652 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 covid-19 (11,573 reports).
- No generic listed
Check it at the source: the ocrelizumab FDA label on DailyMed (effective May 14, 2026, Genentech, Inc.); 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 OCREVUS?OCREVUS may cause serious side effects, including: see " What is the most important information I should know about OCREVUS? " risk of cancers (malignancies) including breast cancer. Follow your healthcare provider's instructions about standard screening guidelines for breast cancer. Inflammation of the colon, or colitis: Tell your healthcare provider right away if you have any symptoms of colitis, such as: Diarrhea (loose stools) or more frequent bowel movements than usual Stools that are black, tarry, sticky or have blood or mucus Severe stomach-area (abdomen) pain or tenderness Liver damage. OCREVUS may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start OCREVUS and while you take OCREVUS if needed. […]
Source: FDA drug label, Genentech, Inc., effective May 14, 2026 (SPL set 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions were: RMS (incidence ≥10% and > REBIF ® ): upper respiratory tract infections and infusion reactions ( 6.1 ) PPMS (incidence ≥10% and > placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections ( 6.1 ) RRMS in pediatric patients 10 years of age and older: Adverse reactions were consistent with those observed in adults with RMS
Table 5 Adverse Reactions in Adult Patients with PPMS with an Incidence of at least 5% for OCREVUS and Higher than Placebo
| Reaction | Adverse Reactions OCREVUS 600 mg IV Every 24 Weeks One dose of OCREVUS (600 mg administered as two 300 mg… (n=486) % | Study 3 Placebo (n=239) % |
|---|---|---|
| Upper respiratory tract infections | 49 | 43 |
| Infusion reactions | 40 | 26 |
| Skin infections | 14 | 11 |
| Lower respiratory tract infections | 10 | 9 |
| Cough | 7 | 3 |
| Diarrhea | 6 | 5 |
| Edema peripheral | 6 | 5 |
| Herpes virus associated infections | 5 | 4 |
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 serious adverse reactions are discussed elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Malignancies [see Warnings and Precautions (5.5) ] Immune-Mediated Colitis [see Warnings and Precautions (5.6) ] Liver Injury [see Warnings and Precautions (5.7) ] The most common adverse reactions were: RMS (incidence ≥10% and > REBIF ® ): upper respiratory tract infections and infusion reactions ( 6.1 ) PPMS (incidence ≥10% and > placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections ( 6.1 ) RRMS in pediatric patients 10 years of age and older: Adverse reactions were consistent with those observed in adults with RMS ( 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 reactions 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 clinical practice.
Source: FDA drug label, Genentech, Inc., effective May 14, 2026 (SPL set 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d), via openFDA; the full label on DailyMed
What do FAERS reports show?
61,652 reports list ocrelizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,519 are coded as a death and 11,217 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, 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?
- Ocrelizumab: 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