Drug · FAERS side-effect profile with label screen
Tocilizumab side effects: what 113,340 FDA adverse event reports show
Drug class
Interleukin-6 Receptor Antagonist
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Actemra, Actemra Actpen
openFDA label
Who reports
113,340 reports · 77% serious · 12,342 with death outcome · 78% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis.
FDA label, Indications and Usage
What it is
Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H 2 L 2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively.
FDA label, Description section
Boxed warning
RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 12Not in label — unassessed 21
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,236 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Human antichimeric antibody positive | 310 | 2,249.6 1,496.8–3,381.2ROR 2,255.8 · calibrated p 3e-20 ✓ | 167.1 EB05 152.0 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Lab value / disease marker | serious n=310 · ♀ 100% (drug 78%) | not reported in cached trials |
| Disability assessment scale score increased | 268 | 1,246.7 891.0–1,744.3ROR 1,249.6 · calibrated p 1e-17 ✓ | 157.5 EB05 142.3 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Lab value / disease marker | serious n=267 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 5,915 | 975.5 915.0–1,040.1ROR 1,029.2 · calibrated p 2e-17 ✓ | 153.7 EB05 150.5 · IC025 +7.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 17.0 (16.2–17.7) | Lab value / disease marker | serious PRR 115.9 · ♀ 98% (drug 78%) · 93% clinician | not reported in cached trials |
| Rheumatoid factor positive | 4,595 | 757.8 709.8–809.2ROR 789.8 · calibrated p 4e-16 ✓ | 147.1 EB05 143.6 · IC025 +7.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 17.5 (16.6–18.4) | Lab value / disease marker | serious n=4,593 · ♀ 99% (drug 78%) · 92% clinician | not reported in cached trials |
| Rheumatoid factor negative | 138 | 676.6 470.8–972.6ROR 677.5 · calibrated p 1e-14 ✓ | 141.1 EB05 122.4 · IC025 +6.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Reporting / coding artifact | serious n=138 · ♀ 45% (drug 78%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 518 | 666.5 553.3–802.8ROR 669.5 · calibrated p 4e-15 ✓ | 142.6 EB05 132.6 · IC025 +6.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 16.5 (14.2–19.3) | Lab value / disease marker | serious n=518 · ♀ 100% (drug 78%) · 95% clinician | not reported in cached trials |
| Swollen joint count increased | 2,404 | 646.1 593.4–703.6ROR 660.1 · calibrated p 3e-15 ✓ | 142.3 EB05 137.6 · IC025 +7.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 14.6 (13.6–15.6) | Lab value / disease marker | serious n=2,403 · ♀ 100% (drug 78%) · 96% clinician | not reported in cached trials |
| Rheumatic fever | 3,320 | 607.2 565.7–651.6ROR 625.5 · calibrated p 5e-15 ✓ | 140.3 EB05 136.4 · IC025 +7.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 16.4 (15.4–17.4) | Likely indication confounding shares a disease stem with the indications wording | serious n=3,319 · ♀ 100% (drug 78%) · 95% clinician | not reported in cached trials |
| Pemphigus | 9,201 | 543.9 522.4–566.4ROR 591.8 · calibrated p 9e-15 ✓ | 136.8 EB05 134.4 · IC025 +7.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 24.2 (23.3–25.2) | Not in label — unassessed | serious PRR 103.0 · ♀ 100% (drug 78%) | not reported in cached trials |
| Red blood cell sedimentation rate | 208 | 539.1 411.2–706.7ROR 540.1 · calibrated p 7e-14 ✓ | 134.8 EB05 120.1 · IC025 +6.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Lab value / disease marker | serious n=208 · 91% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,381 | 451.4 409.1–498.1ROR 457.0 · calibrated p 2e-13 ✓ | 129.9 EB05 124.2 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 15.5 (14.1–16.9) | Not in label — unassessed | serious n=1,381 · ♀ 100% (drug 78%) · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 5,011 | 406.8 387.1–427.4ROR 425.5 · calibrated p 3e-13 ✓ | 126.1 EB05 123.2 · IC025 +6.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 17.2 (16.4–18.1) | Labeled — boxed warning synonym match | serious PRR 94.6 · ♀ 100% (drug 78%) · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 807 | 397.8 351.7–450.0ROR 400.7 · calibrated p 7e-13 ✓ | 124.9 EB05 117.9 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 13.2 (11.7–14.8) | Not in label — unassessed | serious n=807 · ♀ 100% (drug 78%) · 97% clinician | not reported in cached trials |
| C-reactive protein | 614 | 395.0 343.1–454.8ROR 397.2 · calibrated p 8e-13 ✓ | 124.5 EB05 116.5 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 15.2 (13.3–17.5) | Lab value / disease marker | serious n=614 · ♀ 100% (drug 78%) · 96% clinician | not reported in cached trials |
| Granuloma skin | 525 | 325.1 281.8–375.0ROR 326.6 · calibrated p 5e-12 ✓ | 116.6 EB05 108.5 · IC025 +6.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=525 | not reported in cached trials |
| Facet joint syndrome | 1,954 | 306.1 284.7–329.1ROR 311.5 · calibrated p 7e-12 ✓ | 114.4 EB05 110.2 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 16.7 (15.4–18.1) | Not in label — unassessed | serious n=1,954 · ♀ 100% (drug 78%) · 96% clinician | not reported in cached trials |
| Swollen joint count | 150 | 292.6 225.9–379.0ROR 293.0 · calibrated p 2e-11 ✓ | 111.0 EB05 96.9 · IC025 +6.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 13.7 (10.5–18.0) | Not in label — unassessed | serious n=150 · ♀ 100% (drug 78%) · 100% clinician | not reported in cached trials |
| Hand deformity | 7,961 | 291.7 281.6–302.0ROR 313.6 · calibrated p 6e-12 ✓ | 112.4 EB05 110.4 · IC025 +6.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 21.5 (20.6–22.4) | Not in label — unassessed | serious PRR 91.8 · ♀ 98% (drug 78%) · 90% clinician | not reported in cached trials |
| Hepatic enzyme | 85 | 291.0 206.5–410.0ROR 291.2 · calibrated p 4e-11 ✓ | 109.6 EB05 91.4 · IC025 +5.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 18.0 (12.1–26.7) | Labeled (related wording) related wording | serious n=85 · ♀ 100% (drug 78%) · 100% clinician | NCT00720798: 1/2,067 (0.0%) on Tocilizumab (serious AE) |
| Red blood cell sedimentation rate abnormal | 1,380 | 273.0 251.2–296.7ROR 276.4 · calibrated p 2e-11 ✓ | 109.4 EB05 104.7 · IC025 +6.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 786.2 (455.4–1,357.3) | Lab value / disease marker | serious n=1,378 | not reported in cached trials |
| Grip strength | 137 | 270.2 207.4–351.8ROR 270.5 · calibrated p 5e-11 ✓ | 107.5 EB05 93.2 · IC025 +6.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 13.4 (10.1–17.7) | Not in label — unassessed | serious n=137 · ♀ 100% (drug 78%) · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 3,774 | 268.5 255.4–282.2ROR 277.7 · calibrated p 2e-11 ✓ | 108.8 EB05 105.9 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 37.2 (34.5–40.2) | Lab value / disease marker | serious n=3,772 | not reported in cached trials |
| Synovitis | 10,546 | 263.3 255.7–271.1ROR 290.2 · calibrated p 1e-11 ✓ | 108.0 EB05 106.3 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 29.2 (28.1–30.4) | Not in label — unassessed | serious PRR 84.8 | NCT01331837: 1/1,538 (0.1%) on Tocilizumab (serious AE) |
| Musculoskeletal deformity | 135 | 249.9 192.7–324.1ROR 250.2 · calibrated p 1e-10 ✓ | 104.2 EB05 90.2 · IC025 +6.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=135 · ♀ 100% (drug 78%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 951 | 212.7 193.7–233.6ROR 214.5 · calibrated p 2e-10 ✓ | 98.3 EB05 93.1 · IC025 +6.4 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 16.3 (14.6–18.3) | Lab value / disease marker | serious n=951 · 93% clinician | not reported in cached trials |
| Muscle injury | 4,172 | 192.6 184.5–201.1ROR 200.0 · calibrated p 4e-10 ✓ | 93.9 EB05 91.5 · IC025 +6.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 23.3 (21.9–24.7) | Not in label — unassessed | serious PRR 76.4 · ♀ 100% (drug 78%) · 94% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 1,018 | 190.0 174.1–207.4ROR 191.7 · calibrated p 6e-10 ✓ | 93.2 EB05 88.5 · IC025 +6.4 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 13.9 (12.6–15.5) | Not in label — unassessed | serious n=1,018 · ♀ 100% (drug 78%) · 96% clinician | not reported in cached trials |
| Helicobacter infection | 5,103 | 186.7 179.6–194.0ROR 195.4 · calibrated p 5e-10 ✓ | 92.5 EB05 90.4 · IC025 +6.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 18.4 (17.5–19.4) | Not in label — unassessed | serious PRR 73.3 · ♀ 100% (drug 78%) · 93% clinician | not reported in cached trials |
| Body height below normal | 322 | 182.6 156.4–213.1ROR 183.1 · calibrated p 1e-9 ✓ | 91.0 EB05 83.0 · IC025 +6.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Reporting / coding artifact | serious n=322 · ♀ 100% (drug 78%) | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 3,133 | 176.4 168.0–185.2ROR 181.4 · calibrated p 9e-10 ✓ | 89.9 EB05 87.3 · IC025 +6.4 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 27.0 (25.1–29.1) | Labeled (related wording) related wording | serious n=3,131 · ♀ 98% (drug 78%) · 94% clinician | not reported in cached trials |
| Presbyacusis | 147 | 166.7 133.2–208.5ROR 166.9 · calibrated p 3e-9 ✓ | 86.4 EB05 75.3 · IC025 +5.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=147 · ♀ 100% (drug 78%) | not reported in cached trials |
| Dislocation of vertebra | 1,043 | 164.1 151.0–178.4ROR 165.6 · calibrated p 2e-9 ✓ | 86.5 EB05 82.2 · IC025 +6.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 13.9 (12.5–15.4) | Not in label — unassessed | serious n=1,043 · ♀ 100% (drug 78%) · 94% clinician | NCT01331837: 2/1,542 (0.1%) on Tocilizumab (serious AE) |
| Folliculitis | 4,662 | 152.9 147.1–158.9ROR 159.4 · calibrated p 3e-9 ✓ | 83.4 EB05 81.4 · IC025 +6.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 23.8 (22.5–25.3) | Not in label — unassessed | serious PRR 73.6 · ♀ 100% (drug 78%) · 94% clinician | not reported in cached trials |
| Bone erosion | 1,573 | 148.3 138.8–158.5ROR 150.4 · calibrated p 5e-9 ✓ | 82.0 EB05 78.6 · IC025 +6.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 29.1 (26.1–32.5) | Not in label — unassessed | serious n=1,571 · 91% clinician | not reported in cached trials |
| Joint laxity | 131 | 141.5 112.6–177.8ROR 141.6 · calibrated p 1e-8 ✓ | 79.0 EB05 68.3 · IC025 +5.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=130 · ♀ 100% (drug 78%) | not reported in cached trials |
| Blood parathyroid hormone decreased | 612 | 129.1 116.4–143.2ROR 129.8 · calibrated p 2e-8 ✓ | 75.7 EB05 70.8 · IC025 +6.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Lab value / disease marker | serious n=612 | not reported in cached trials |
| Anticipatory anxiety | 110 | 127.1 99.6–162.2ROR 127.2 · calibrated p 3e-8 ✓ | 74.2 EB05 63.3 · IC025 +5.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: only this drug | Not in label — unassessed | serious n=110 · ♀ 100% (drug 78%) | not reported in cached trials |
| Contraindicated product administered | 12,157 | 125.2 122.5–128.1ROR 140.1 · calibrated p 8e-9 ✓ | 74.5 EB05 73.4 · IC025 +6.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 45.0 (43.0–47.0) | Reporting / coding artifact | age-adj. PRR 110.5 · serious PRR 69.0 | not reported in cached trials |
| Retinitis | 672 | 124.9 113.2–137.8ROR 125.7 · calibrated p 2e-8 ✓ | 74.2 EB05 69.6 · IC025 +6.0 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 14.0 (12.3–15.9) | Not in label — unassessed | serious n=672 · ♀ 100% (drug 78%) · 97% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 218 | 123.6 104.1–146.8ROR 123.8 · calibrated p 3e-8 ✓ | 73.5 EB05 65.6 · IC025 +5.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 8.6 (7.1–10.5) | Not in label — unassessed | serious n=218 · ♀ 100% (drug 78%) · 100% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Liver injury | 13,615 | 8.78.6–8.8 | signal |
| Interstitial lung disease | 3,964 | 7.97.7–8.2 | signal |
| Serious infection | 17,798 | 4.34.3–4.4 | signal |
| Opportunistic infection | 2,907 | 4.03.9–4.2 | signal |
| Hyperglycaemia / diabetes | 5,339 | 2.92.8–3.0 | signal |
| Tendon disorder | 580 | 2.82.6–3.1 | signal |
| Anaphylaxis / angioedema | 1,503 | 2.22.1–2.3 | signal |
| Fall / fracture | 4,063 | 2.01.9–2.0 | raised |
| Depression | 2,643 | 1.71.7–1.8 | raised |
| Pancreatitis | 738 | 1.71.6–1.8 | raised |
| Thrombocytopenia | 1,937 | 1.61.6–1.7 | raised |
| Neutropenia / agranulocytosis | 1,924 | 1.41.4–1.5 | raised |
| Venous thromboembolism | 1,613 | 1.41.3–1.4 | raised |
| Malignancy | 2,528 | 1.21.2–1.3 | raised |
| Gi bleeding | 1,157 | 1.21.1–1.2 | raised |
| Rhabdomyolysis / myopathy | 469 | 1.11.0–1.2 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Tocilizumab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT01331837 — A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascula (N=3080, PHASE4; 617 AE terms posted; arms: Etanercept; Tocilizumab)
- NCT00720798 — An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocili (N=2067, PHASE3; 616 AE terms posted; arms: Tocilizumab)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 35,434 | 5.1 5.0–5.1ROR 6.9 · calibrated p 0.101 | 5.0 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 43.3 (42.3–44.4) | Reporting / coding artifact | age-adj. PRR 6.0 · serious PRR 9.5 | not reported in cached trials |
| Rheumatoid arthritis | 22,731 | 46.4 45.8–47.0ROR 57.8 · calibrated p 5e-6 ✓ | 37.2 EB05 36.8 · IC025 +5.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 36.2 (35.2–37.3) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 42.6 · serious PRR 33.4 | NCT01331837: 12/1,538 (0.8%) on Tocilizumab (serious AE) |
| Off label use (used outside approved label) | 20,459 | 4.4 4.4–4.5ROR 5.2 · calibrated p 0.214 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 62.4 (60.0–64.9) | Reporting / coding artifact | age-adj. PRR 4.4 · serious PRR 5.1 | not reported in cached trials |
| Pain | 20,222 | 6.3 6.2–6.3ROR 7.4 · calibrated p 0.084 | 6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 25.1 (24.4–25.7) | Labeled adverse reaction exact term | age-adj. PRR 6.2 · serious PRR 6.7 | NCT01331837: 3/1,538 (0.2%) on Tocilizumab (serious AE) |
| Arthralgia (joint pain) | 17,305 | 8.0 7.9–8.1ROR 9.3 · calibrated p 0.041 ✓ | 7.7 EB05 7.6 · IC025 +2.9 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 24.8 (24.1–25.5) | Labeled adverse reaction exact term | age-adj. PRR 7.4 · serious PRR 9.4 | NCT01331837: 1/1,538 (0.1%) on Tocilizumab (serious AE) |
| Joint swelling | 16,323 | 28.9 28.4–29.3ROR 33.6 · calibrated p 1e-4 ✓ | 25.0 EB05 24.7 · IC025 +4.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 26.4 (25.6–27.2) | Not in label — unassessed | age-adj. PRR 24.7 · serious PRR 29.3 | not reported in cached trials |
| Fatigue (tiredness) | 15,377 | 3.7 3.7–3.8ROR 4.1 · calibrated p 0.353 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 32.0 (31.0–33.1) | Labeled adverse reaction exact term | age-adj. PRR 3.5 · serious PRR 5.0 | NCT00720798: 128/2,067 (6.2%) on Tocilizumab |
| Rash | 13,763 | 6.0 5.9–6.1ROR 6.7 · calibrated p 0.110 | 5.9 EB05 5.8 · IC025 +2.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 30.4 (29.4–31.5) | Labeled adverse reaction exact term | age-adj. PRR 5.9 · serious PRR 9.2 | NCT01331837: 1/1,538 (0.1%) on Tocilizumab (serious AE) |
| Drug intolerance | 13,120 | 29.1 28.6–29.6ROR 32.7 · calibrated p 2e-4 ✓ | 25.2 EB05 24.8 · IC025 +4.6 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 38.0 (36.5–39.6) | Reporting / coding artifact | age-adj. PRR 35.2 · serious PRR 30.6 | not reported in cached trials |
| Contraindicated product administered | 12,157 | 125.2 122.5–128.1ROR 140.1 · calibrated p 8e-9 ✓ | 74.5 EB05 73.4 · IC025 +6.2 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 45.0 (43.0–47.0) | Reporting / coding artifact | age-adj. PRR 110.5 · serious PRR 69.0 | not reported in cached trials |
| Arthropathy | 10,904 | 44.8 43.9–45.7ROR 49.5 · calibrated p 1e-5 ✓ | 36.1 EB05 35.6 · IC025 +5.1 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 30.4 (29.2–31.6) | Not in label — unassessed | age-adj. PRR 44.2 · serious PRR 32.9 | NCT00720798: 1/2,067 (0.0%) on Tocilizumab (serious AE) |
| Alopecia (hair loss) | 10,737 | 10.6 10.4–10.8ROR 11.6 · calibrated p 0.019 ✓ | 10.1 EB05 9.9 · IC025 +3.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 25.9 (24.9–26.9) | Not in label — unassessed | age-adj. PRR 8.8 · serious PRR 15.6 · ♀ 100% (drug 78%) | not reported in cached trials |
| Abdominal discomfort | 10,569 | 12.4 12.2–12.7ROR 13.6 · calibrated p 0.010 ✓ | 11.7 EB05 11.5 · IC025 +3.5 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 26.0 (25.1–27.0) | Labeled adverse reaction exact term | age-adj. PRR 11.1 · serious PRR 19.4 | not reported in cached trials |
| Synovitis | 10,546 | 263.3 255.7–271.1ROR 290.2 · calibrated p 1e-11 ✓ | 108.0 EB05 106.3 · IC025 +6.7 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 29.2 (28.1–30.4) | Not in label — unassessed | serious PRR 84.8 | NCT01331837: 1/1,538 (0.1%) on Tocilizumab (serious AE) |
| Swelling | 10,488 | 23.3 22.8–23.8ROR 25.6 · calibrated p 6e-4 ✓ | 20.8 EB05 20.4 · IC025 +4.3 3/3 methods agree vs other Interleukin-6 Receptor Antagonists: PRR 28.6 (27.5–29.7) | Labeled adverse reaction exact term | age-adj. PRR 21.2 · serious PRR 24.6 | NCT01331837: 1/1,538 (0.1%) on Tocilizumab (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pemphigus — n=9,201, PRR 543.9
- Deep vein thrombosis postoperative — n=1,381, PRR 451.4
- Lupus vulgaris — n=807, PRR 397.8
- Granuloma skin — n=525, PRR 325.1
- Facet joint syndrome — n=1,954, PRR 306.1
- Swollen joint count — n=150, PRR 292.6
- Hand deformity — n=7,961, PRR 291.7
- Grip strength — n=137, PRR 270.2
- Synovitis — n=10,546, PRR 263.3 (also seen in trial arm)
- Musculoskeletal deformity — n=135, PRR 249.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tocilizumab ↔ Gastrointestinal perforation.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Tocilizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Tocilizumab are rheumatoid arthritis, pain, arthralgia, joint swelling, fatigue, rash. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Tocilizumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Do FAERS signals prove that Tocilizumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13, effective 20251216; matched on
openfda.generic_name.exact:"TOCILIZUMAB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,276 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
TOCILIZUMAB, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.