Methotrexate vs Hydroxychloroquine: side effects in FDA adverse event reports
At a glance
| Methotrexate | Hydroxychloroquine | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | – |
| FAERS reports | 483,097 | 90,536 |
| Serious | 73% | 75% |
| Death outcome | 37,640 | 6,265 |
| Boxed warning | Yes WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS • Methotrexate Injection can cause embr | No |
Signals both drugs share
| Reaction | Methotrexate | Hydroxychloroquine | Label screen (A / B) |
|---|---|---|---|
| Pericarditis | 6,863 · PRR 30.0 | 5,077 · PRR 101.6 | Labeled adverse reaction / Not in label — unassessed |
| Duodenal ulcer perforation | 5,067 · PRR 97.3 | 3,870 · PRR 260.7 | Labeled (related wording) / Not in label — unassessed |
| Muscle injury | 4,306 · PRR 47.5 | 3,019 · PRR 135.1 | Not in label — unassessed / Labeled (related wording) |
| Sleep disorder due to general medical condition, insomnia type | 3,191 · PRR 42.2 | 2,401 · PRR 138.1 | Not in label — unassessed / Labeled (related wording) |
| Bone erosion | 2,084 · PRR 61.7 | 1,129 · PRR 108.4 | Labeled (related wording) / Not in label — unassessed |
| Synovitis | 13,569 · PRR 133.8 | 8,328 · PRR 199.7 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 9,382 · PRR 135.9 | 7,446 · PRR 351.1 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 8,885 · PRR 92.3 | 6,673 · PRR 243.2 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,277 · PRR 46.1 | 3,923 · PRR 145.4 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 5,035 · PRR 40.8 | 3,344 · PRR 111.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,282 · PRR 133.3 | 2,381 · PRR 280.5 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,964 · PRR 71.6 | 1,242 · PRR 151.1 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,372 · PRR 101.8 | 1,022 · PRR 254.3 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,211 · PRR 51.4 | 854 · PRR 144.7 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,109 · PRR 52.7 | 787 · PRR 148.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 867 · PRR 117.7 | 626 · PRR 259.4 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 790 · PRR 38.5 | 537 · PRR 109.9 | Not in label — unassessed / Not in label — unassessed |
| Granuloma skin | 539 · PRR 80.8 | 364 · PRR 182.4 | Not in label — unassessed / Not in label — unassessed |
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 Hydroxychloroquine
- Glossodynia — n=6,867, PRR 102.8 Labeled (related wording)
Common questions
Which has more reported side effects, Methotrexate or Hydroxychloroquine?
Methotrexate has 483,097 FAERS reports and Hydroxychloroquine 90,536. 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 75%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Methotrexate and Hydroxychloroquine share?
Both drugs carry disproportionality signals for pericarditis, duodenal ulcer perforation, muscle injury, sleep disorder due to general medical condition, insomnia type, bone erosion. Shared signals often reflect a shared drug class or the condition both are used for.
Is Methotrexate or Hydroxychloroquine 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.