Methotrexate vs Golimumab: side effects in FDA adverse event reports
At a glance
| Methotrexate | Golimumab | |
|---|---|---|
| Drug class | – | Tumor Necrosis Factor Blocker |
| Brand names | – | Simponi Aria |
| FAERS reports | 483,097 | 12,299 |
| Serious | 73% | 76% |
| Death outcome | 37,640 | 2,587 |
| Boxed warning | Yes WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS • Methotrexate Injection can cause embr | 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 | Methotrexate | Golimumab | Label screen (A / B) |
|---|---|---|---|
| Pericarditis | 6,863 · PRR 30.0 | 5,772 · PRR 130.7 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 5,067 · PRR 97.3 | 4,452 · PRR 385.1 | Labeled (related wording) / Not in label — unassessed |
| Bone erosion | 2,084 · PRR 61.7 | 1,080 · PRR 108.0 | Labeled (related wording) / Not in label — unassessed |
| Peripheral venous disease | 1,635 · PRR 29.6 | 1,317 · PRR 121.3 | Not in label — unassessed / Labeled (related wording) |
| Granuloma skin | 539 · PRR 80.8 | 288 · PRR 131.3 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 13,569 · PRR 133.8 | 7,401 · PRR 171.8 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 9,382 · PRR 135.9 | 8,315 · PRR 508.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,885 · PRR 92.3 | 7,128 · PRR 297.8 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,277 · PRR 46.1 | 4,593 · PRR 203.0 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 5,035 · PRR 40.8 | 4,315 · PRR 177.4 | Not in label — unassessed / Not in label — unassessed |
| Muscle injury | 4,306 · PRR 47.5 | 3,841 · PRR 217.9 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,282 · PRR 133.3 | 3,014 · PRR 561.2 | Likely indication confounding / Likely indication confounding |
| Sleep disorder due to general medical condition, insomnia type | 3,191 · PRR 42.2 | 2,885 · PRR 201.0 | Not in label — unassessed / Not in label — unassessed |
| Facet joint syndrome | 1,964 · PRR 71.6 | 1,618 · PRR 261.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,372 · PRR 101.8 | 1,186 · PRR 382.2 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,211 · PRR 51.4 | 981 · PRR 195.1 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,109 · PRR 52.7 | 978 · PRR 233.6 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 867 · PRR 117.7 | 743 · PRR 415.7 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 790 · PRR 38.5 | 617 · PRR 144.6 | Not in label — unassessed / Not in label — unassessed |
| Seronegative arthritis | 555 · PRR 42.0 | 393 · PRR 132.8 | Likely indication confounding / Likely indication confounding |
Labeled signals distinctive to Methotrexate
- Lymphoproliferative disorder — n=1,503, PRR 44.9 Labeled (related wording)
- Rheumatoid lung — n=451, PRR 37.7 Labeled (related wording)
Labeled signals distinctive to Golimumab
- 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, Methotrexate or Golimumab?
Methotrexate has 483,097 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 (73% vs 76%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Methotrexate and Golimumab share?
Both drugs carry disproportionality signals for pericarditis, duodenal ulcer perforation, bone erosion, peripheral venous disease, granuloma skin. Shared signals often reflect a shared drug class or the condition both are used for.
Is Methotrexate 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.