What the label lists and what reports show
Tocilizumab side effects
Tocilizumab's FDA label: “Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.” FAERS holds 113,819 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 pain (20,239 reports).
- No generic listed
- Boxed warning
Check it at the source: the tocilizumab FDA label on DailyMed (effective December 16, 2025, 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 with ACTEMRA?ACTEMRA can cause serious side effects, including: See " What is the most important information I should know about ACTEMRA? " Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use ACTEMRA. Your healthcare provider may do blood tests before you start treatment with ACTEMRA and while you are using ACTEMRA. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection: feel very tired vomiting chills dark urine skin or eyes look yellow clay-colored bowel movements stomach discomfort skin rash little or no appetite fevers muscle aches Serious Allergic Reactions. Serious allergic reactions, including death, can happen with ACTEMRA. […]
Source: FDA drug label, Genentech, Inc., effective December 16, 2025 (SPL set 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.
Table 2 Adverse Reactions Occurring in at Least 2% or More of Patients on 4 or 8 mg per kg ACTEMRA plus DMARD and at Least 1% Greater Than That Observed in Patients on Placebo plus DMARD
| Preferred Term | ACTEMRA 8 mg per kg MONOTHERAPY N = 288 (%) | Methotrexate N = 284 (%) | ACTEMRA 4 mg per kg + DMARDs N = 774 (%) | ACTEMRA 8 mg per kg + DMARDs N = 1582 (%) | Placebo + DMARDs N = 1170 (%) |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | 7 | 5 | 6 | 8 | 6 |
| Nasopharyngitis | 7 | 6 | 4 | 6 | 4 |
| Headache | 7 | 2 | 6 | 5 | 3 |
| Hypertension | 6 | 2 | 4 | 4 | 3 |
| ALT increased | 6 | 4 | 3 | 3 | 1 |
| Dizziness | 3 | 1 | 2 | 3 | 2 |
| Bronchitis | 3 | 2 | 4 | 3 | 3 |
| Rash | 2 | 1 | 4 | 3 | 1 |
| Mouth Ulceration | 2 | 2 | 1 | 2 | 1 |
| Abdominal Pain Upper | 2 | 2 | 3 | 3 | 2 |
| Gastritis | 1 | 2 | 1 | 2 | 1 |
| Transaminase increased | 1 | 5 | 2 | 2 | 1 |
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 described elsewhere in labeling: Serious Infections [see Warnings and Precautions (5.1) ] Gastrointestinal Perforations [see Warnings and Precautions (5.2) ] Laboratory Parameters [see Warnings and Precautions (5.4) ] Immunosuppression [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.6) ] Demyelinating Disorders [see Warnings and Precautions (5.7) ] Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions (5.8) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. ( 6 ) 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 in Rheumatoid Arthritis Patients Treated with Intravenous ACTEMRA (ACTEMRA-IV) The ACTEMRA-IV data in rheumatoid arthritis (RA) includes 5 double-blind, controlled, multicenter studies.
Source: FDA drug label, Genentech, Inc., effective December 16, 2025 (SPL set 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13), via openFDA; the full label on DailyMed
What do FAERS reports show?
113,819 reports list tocilizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12,363 are coded as a death and 29,312 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 20 reactions below, 7 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?
- Tocilizumab: 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