Prednisone vs Hydroxychloroquine: side effects in FDA adverse event reports
At a glance
| Prednisone | Hydroxychloroquine | |
|---|---|---|
| Drug class | Corticosteroid | – |
| Brand names | – | – |
| FAERS reports | 499,794 | 90,536 |
| Serious | 79% | 75% |
| Death outcome | 52,153 | 6,265 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Prednisone | Hydroxychloroquine | Label screen (A / B) |
|---|---|---|---|
| Glossodynia | 8,626 · PRR 25.9 | 6,867 · PRR 102.8 | Not in label — unassessed / Labeled (related wording) |
| Duodenal ulcer perforation | 4,860 · PRR 82.3 | 3,870 · PRR 260.7 | Labeled (related wording) / Not in label — unassessed |
| Muscle injury | 4,043 · PRR 40.2 | 3,019 · PRR 135.1 | Not in label — unassessed / Labeled (related wording) |
| Sleep disorder due to general medical condition, insomnia type | 3,038 · PRR 37.0 | 2,401 · PRR 138.1 | Not in label — unassessed / Labeled (related wording) |
| Synovitis | 8,900 · PRR 40.3 | 8,328 · PRR 199.7 | Likely indication confounding / Not in label — unassessed |
| Pemphigus | 9,174 · PRR 119.7 | 7,446 · PRR 351.1 | Likely indication confounding / Not in label — unassessed |
| Hand deformity | 7,949 · PRR 64.7 | 6,673 · PRR 243.2 | Not in label — unassessed / Not in label — unassessed |
| Pericarditis | 6,736 · PRR 28.0 | 5,077 · PRR 101.6 | Not in label — unassessed / Not in label — unassessed |
| Helicobacter infection | 5,030 · PRR 40.4 | 3,923 · PRR 145.4 | Not in label — unassessed / Not in label — unassessed |
| Folliculitis | 4,563 · PRR 32.7 | 3,344 · PRR 111.0 | Not in label — unassessed / Not in label — unassessed |
| Rheumatic fever | 3,108 · PRR 104.3 | 2,381 · PRR 280.5 | Likely indication confounding / Likely indication confounding |
| Facet joint syndrome | 1,801 · PRR 55.5 | 1,242 · PRR 151.1 | Not in label — unassessed / Not in label — unassessed |
| Bone erosion | 1,189 · PRR 20.8 | 1,129 · PRR 108.4 | Not in label — unassessed / Not in label — unassessed |
| Deep vein thrombosis postoperative | 1,287 · PRR 80.1 | 1,022 · PRR 254.3 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,083 · PRR 39.3 | 854 · PRR 144.7 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,072 · PRR 47.2 | 787 · PRR 148.8 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 814 · PRR 91.1 | 626 · PRR 259.4 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 721 · PRR 31.4 | 537 · PRR 109.9 | Likely indication confounding / Not in label — unassessed |
| Granuloma skin | 482 · PRR 57.9 | 364 · PRR 182.4 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Prednisone
- Nocardiosis — n=888, PRR 21.9 Labeled (related wording)
- Steroid diabetes — n=492, PRR 21.0 Labeled (related wording)
- Secondary immunodeficiency — n=420, PRR 22.4 Labeled (related wording)
Labeled signals distinctive to Hydroxychloroquine
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Prednisone or Hydroxychloroquine?
Prednisone has 499,794 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 (79% vs 75%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Prednisone and Hydroxychloroquine share?
Both drugs carry disproportionality signals for glossodynia, duodenal ulcer perforation, muscle injury, sleep disorder due to general medical condition, insomnia type, synovitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Prednisone 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.