Tocilizumab vs Golimumab: side effects in FDA adverse event reports
At a glance
| Tocilizumab | Golimumab | |
|---|---|---|
| Drug class | Interleukin-6 Receptor Antagonist | Tumor Necrosis Factor Blocker |
| Brand names | Actemra, Actemra Actpen | Simponi Aria |
| FAERS reports | 113,340 | 12,299 |
| Serious | 77% | 76% |
| Death outcome | 12,342 | 2,587 |
| Boxed warning | Yes RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see | Yes SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections lea |
Signals both drugs share
| Reaction | Tocilizumab | Golimumab | Label screen (A / B) |
|---|---|---|---|
| Duodenal ulcer perforation | 5,011 · PRR 406.8 | 4,452 · PRR 385.1 | Labeled — boxed warning / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 3,133 · PRR 176.4 | 2,885 · PRR 201.0 | Labeled (related wording) / Not in label — unassessed |
| Granuloma skin | 525 · PRR 325.1 | 288 · PRR 131.3 | Not in label — unassessed / Labeled (related wording) |
| Hepatic enzyme | 85 · PRR 291.0 | 91 · PRR 468.0 | Labeled (related wording) / Labeled (related wording) |
| Synovitis | 10,546 · PRR 263.3 | 7,401 · PRR 171.8 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 9,201 · PRR 543.9 | 8,315 · PRR 508.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 7,961 · PRR 291.7 | 7,128 · PRR 297.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,103 · PRR 186.7 | 4,593 · PRR 203.0 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,662 · PRR 152.9 | 4,315 · PRR 177.4 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 4,172 · PRR 192.6 | 3,841 · PRR 217.9 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,320 · PRR 607.2 | 3,014 · PRR 561.2 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,954 · PRR 306.1 | 1,618 · PRR 261.8 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,573 · PRR 148.3 | 1,080 · PRR 108.0 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,381 · PRR 451.4 | 1,186 · PRR 382.2 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,043 · PRR 164.1 | 981 · PRR 195.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,018 · PRR 190.0 | 978 · PRR 233.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 807 · PRR 397.8 | 743 · PRR 415.7 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 672 · PRR 124.9 | 617 · PRR 144.6 | Not in label — unassessed / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 218 · PRR 123.6 | 212 · PRR 157.2 | Not in label — unassessed / Not in label — unassessed |
| Swollen joint count | 150 · PRR 292.6 | 130 · PRR 278.1 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Tocilizumab
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Golimumab
- Peripheral venous disease — n=1,317, PRR 121.3 Labeled (related wording)
- Malignant mediastinal neoplasm — n=56, PRR 265.4 Labeled (related wording)
Common questions
Which has more reported side effects, Tocilizumab or Golimumab?
Tocilizumab has 113,340 FAERS reports and Golimumab 12,299. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (77% vs 76%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Tocilizumab and Golimumab share?
Both drugs carry disproportionality signals for duodenal ulcer perforation, sleep disorder due to general medical condition, insomnia type, granuloma skin, hepatic enzyme, synovitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Tocilizumab or Golimumab safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.