Etanercept vs Golimumab: side effects in FDA adverse event reports
At a glance
| Etanercept | Golimumab | |
|---|---|---|
| Drug class | Tumor Necrosis Factor Blocker | Tumor Necrosis Factor Blocker |
| Brand names | Enbrel | Simponi Aria |
| FAERS reports | 595,118 | 12,299 |
| Serious | 36% | 76% |
| Death outcome | 17,154 | 2,587 |
| Boxed warning | Yes SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS | 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 | Etanercept | Golimumab | Label screen (A / B) |
|---|---|---|---|
| Granuloma skin | 513 · PRR 56.8 | 288 · PRR 131.3 | Labeled (related wording) / Labeled (related wording) |
| Synovitis | 11,207 · PRR 57.3 | 7,401 · PRR 171.8 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 8,412 · PRR 73.6 | 8,315 · PRR 508.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,536 · PRR 65.9 | 7,128 · PRR 297.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 4,820 · PRR 31.1 | 4,593 · PRR 203.0 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 4,537 · PRR 56.6 | 4,452 · PRR 385.1 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,400 · PRR 25.6 | 4,315 · PRR 177.4 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 3,852 · PRR 30.6 | 3,841 · PRR 217.9 | Not in label — unassessed / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 3,315 · PRR 36.8 | 2,885 · PRR 201.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,908 · PRR 69.9 | 3,014 · PRR 561.2 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,651 · PRR 38.2 | 1,618 · PRR 261.8 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,731 · PRR 33.1 | 1,080 · PRR 108.0 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,212 · PRR 56.5 | 1,186 · PRR 382.2 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,027 · PRR 29.7 | 981 · PRR 195.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 976 · PRR 32.5 | 978 · PRR 233.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 662 · PRR 43.6 | 743 · PRR 415.7 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 444 · PRR 22.6 | 393 · PRR 132.8 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Etanercept
- Injection site warmth — n=10,385, PRR 35.3 Labeled (related wording)
- Injection site haematoma — n=6,063, PRR 24.4 Labeled (related wording)
- Rheumatoid nodule — n=1,295, PRR 30.1 Labeled (related wording)
- Injection site recall reaction — n=486, PRR 911.8 Labeled (related wording)
- Injection site macule — n=470, PRR 74.5 Labeled (related wording)
Labeled signals distinctive to Golimumab
- Peripheral venous disease — n=1,317, PRR 121.3 Labeled (related wording)
- Hepatic enzyme — n=91, PRR 468.0 Labeled (related wording)
- Malignant mediastinal neoplasm — n=56, PRR 265.4 Labeled (related wording)
Common questions
Which has more reported side effects, Etanercept or Golimumab?
Etanercept has 595,118 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 (36% vs 76%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Etanercept and Golimumab share?
Both drugs carry disproportionality signals for granuloma skin, synovitis, pemphigus, hand deformity, helicobacter infection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Etanercept 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.