Prescription medicine
Ocrelizumab Brand names: Ocrevus
Ocrelizumab (Ocrevus) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ocrelizumab FDA label on DailyMed (effective May 14, 2026, Genentech, Inc.); the BLA 761053 record on Drugs@FDA; every ocrelizumab label on DailyMed.
Highlights of the record
FDA label of May 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.
Forms and strengths
- 300 mg/10ml
Injection.
On the market
- Earliest approval on file
- March 28, 2017 Ocrevus, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 61,652 through July 30, 2026
What is ocrelizumab used for?
From the label: indications and usageOCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more. […]
FDA pharmacologic class: CD20-directed Cytolytic Antibody.
Source: FDA drug label (OCREVUS), Genentech, Inc., effective May 14, 2026 (SPL set 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d), via openFDA; the full label on DailyMed
What does the patient leaflet for ocrelizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OCREVUS?OCREVUS can cause serious side effects, including: Infusion reactions: Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin rash hives tiredness coughing or wheezing trouble breathing throat irritation or pain feeling faint fever redness on your face (flushing) nausea headache swelling of the throat dizziness shortness of breath fatigue fast heart beat These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion. Infection: Infections are a common side effect. OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with OCREVUS, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores shingles genital sores skin rash pain itching Signs of a more serious herpes infection include: changes in vision eye redness or eye pain severe or persistent headache stiff neck confusion Signs of infection can happen during treatment or after you have received your last dose of OCREVUS. […]
Source: FDA drug label (OCREVUS), Genentech, Inc., effective May 14, 2026 (SPL set 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d), via openFDA; the full label on DailyMed
Is there a generic for ocrelizumab (Ocrevus)?
No generic ocrelizumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ocrelizumab label say about other medicines?
The ocrelizumab label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | The addition of an antipyretic (e.g., acetaminophen) may also be considered [see Dosage and Administration (2.2) ]. |
| Fingolimod | drug interactions | When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating OCREVUS [see Warnings and Precautions (5.2) ]. |
| Interferon beta 1a | warnings and precautions | Breast cancer in adults occurred in 6 of 781 females treated with OCREVUS and none of 668 females treated with REBIF or placebo. |
| Methylprednisolone | warnings and precautions | In multiple sclerosis (MS) clinical trials, all adult and pediatric patients who were treated with OCREVUS received premedication with methylprednisolone (or an equivalent steroid), and may have also received an antihistamine (all pediatric patients) and/or an analgesic/antipyretic to reduce the risk of infusion … |
| Mitoxantrone | drug interactions | When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating OCREVUS [see Warnings and Precautions (5.2) ]. |
| Natalizumab | drug interactions | When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating OCREVUS [see Warnings and Precautions (5.2) ]. |
| Teriflunomide | drug interactions | When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating OCREVUS [see Warnings and Precautions (5.2) ]. |
Source: FDA drug label (OCREVUS), 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 for ocrelizumab?
The FDA Adverse Event Reporting System holds 61,652 reports that list ocrelizumab among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cd20-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Ocrelizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other