Hydroxychloroquine vs Sulfasalazine: side effects in FDA adverse event reports
At a glance
| Hydroxychloroquine | Sulfasalazine | |
|---|---|---|
| Drug class | – | Aminosalicylate |
| Brand names | – | – |
| FAERS reports | 90,536 | 77,779 |
| Serious | 75% | 84% |
| Death outcome | 6,265 | 7,233 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Hydroxychloroquine | Sulfasalazine | Label screen (A / B) |
|---|---|---|---|
| Pericarditis | 5,077 · PRR 101.6 | 5,998 · PRR 152.1 | Not in label — unassessed / Labeled adverse reaction |
| Muscle injury | 3,019 · PRR 135.1 | 3,407 · PRR 192.4 | Labeled (related wording) / Not in label — unassessed |
| Sleep disorder due to general medical condition, insomnia type | 2,401 · PRR 138.1 | 2,798 · PRR 208.5 | Labeled (related wording) / Not in label — unassessed |
| Subcutaneous drug absorption impaired | 170 · PRR 105.1 | 228 · PRR 194.9 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 8,328 · PRR 199.7 | 9,222 · PRR 284.5 | Not in label — unassessed / Not in label — unassessed |
| Pemphigus | 7,446 · PRR 351.1 | 8,068 · PRR 508.9 | Not in label — unassessed / Not in label — unassessed |
| Hand deformity | 6,673 · PRR 243.2 | 7,498 · PRR 367.0 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 3,923 · PRR 145.4 | 4,755 · PRR 237.5 | Not in label — unassessed / Not in label — unassessed |
| Duodenal ulcer perforation | 3,870 · PRR 260.7 | 4,720 · PRR 495.2 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 3,344 · PRR 111.0 | 3,905 · PRR 164.5 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 2,381 · PRR 280.5 | 3,055 · PRR 644.1 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,242 · PRR 151.1 | 1,686 · PRR 313.3 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,129 · PRR 108.4 | 1,423 · PRR 181.8 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,022 · PRR 254.3 | 1,252 · PRR 485.1 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 854 · PRR 144.7 | 1,073 · PRR 253.2 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 787 · PRR 148.8 | 969 · PRR 251.5 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 626 · PRR 259.4 | 844 · PRR 675.8 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 537 · PRR 109.9 | 743 · PRR 217.6 | Not in label — unassessed / Not in label — unassessed |
| Granuloma skin | 364 · PRR 182.4 | 507 · PRR 432.0 | Not in label — unassessed / Not in label — unassessed |
| Musculoskeletal deformity | 120 · PRR 241.5 | 138 · PRR 385.0 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Hydroxychloroquine
- Glossodynia — n=6,867, PRR 102.8 Labeled (related wording)
Labeled signals distinctive to Sulfasalazine
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Hydroxychloroquine or Sulfasalazine?
Hydroxychloroquine has 90,536 FAERS reports and Sulfasalazine 77,779. 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 (75% vs 84%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Hydroxychloroquine and Sulfasalazine share?
Both drugs carry disproportionality signals for pericarditis, muscle injury, sleep disorder due to general medical condition, insomnia type, subcutaneous drug absorption impaired, synovitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Hydroxychloroquine or Sulfasalazine 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.