Corticosteroid side effects compared: 33 drugs, 2,393,948 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Prednisone | 499,794 | 79% | 52,153 | – | Duodenal ulcer perforation; Nocardiosis; Steroid diabetes | Glossodynia; Hand deformity |
| Dexamethasone | 294,871 | 84% | 47,727 | – | Secondary immunodeficiency | Plasma cell myeloma; Febrile neutropenia |
| Prednisolone | 179,389 | 96% | 28,710 | – | Nocardiosis; Bk virus infection; Varicella zoster virus infection | Transplant rejection; Kidney transplant rejection |
| Prednisolone | 179,371 | 96% | 28,710 | – | Nocardiosis; Bk virus infection; Varicella zoster virus infection | Transplant rejection; Kidney transplant rejection |
| Prednisolone | 179,370 | 96% | 28,710 | – | Nocardiosis; Bk virus infection; Varicella zoster virus infection | Transplant rejection; Kidney transplant rejection |
| Methylprednisolone | 137,404 | 90% | 23,035 | – | Graft versus host disease in gastrointestinal tract; Steroid diabetes; Secondary immunodeficiency | Facet joint syndrome; Cytomegalovirus viraemia |
| Hydrocortisone | 88,710 | 82% | 11,614 | – | Duodenal ulcer perforation; Steroid withdrawal syndrome; Secondary immunodeficiency | Hand deformity; Helicobacter infection |
| Hydrocortisone | 72,236 | 83% | 10,727 | – | Duodenal ulcer perforation; Steroid withdrawal syndrome; Topical steroid withdrawal reaction | Hand deformity; Helicobacter infection |
| Hydrocortisone Cream | 66,971 | 83% | 9,817 | – | – | – |
| Hydrocortisone 1% (Hydrocortisone) | 66,703 | 83% | 9,800 | – | – | – |
| Hydrocortisone Cream 1% | 66,664 | 83% | 9,795 | – | – | – |
| Hydrocortisone Lotion (Hydrocortisone) | 66,636 | 83% | 9,796 | – | – | – |
| Hydrocortisone Spray (Hydrocortisone) | 66,627 | 83% | 9,795 | – | – | – |
| Hydrocortisone Continuous Spray (Hydrocortisone) | 66,627 | 83% | 9,795 | – | – | – |
| Drs. Hydrocortisone (Hydrocortisone) | 66,627 | 83% | 9,795 | – | – | – |
| Anti-Pruritic (Hydrocortisone) | 66,627 | 83% | 9,795 | – | – | – |
| Budesonide (Pulmicort Flexhaler) | 58,545 | 65% | 3,687 | – | Chronic sinusitis; Conjunctivitis allergic; Respiratory symptom | Dust allergy; Mycotic allergy |
| Methylprednisolone | 46,150 | 89% | 8,762 | – | Duodenal ulcer perforation | Helicobacter infection; Folliculitis |
| Triamcinolone Acetonide | 30,695 | 46% | 3,066 | – | Duodenal ulcer perforation; Subcutaneous drug absorption impaired; Hypothalamic pituitary adrenal axis suppression | Facet joint syndrome; Peripheral venous disease |
| Desoximetasone | 18,941 | 95% | 5,061 | – | Folliculitis | Systemic lupus erythematosus; Pemphigus |
| Budesonide (Pulmicort Flexhaler) | 10,306 | 42% | 1,280 | – | Chronic obstructive pulmonary disease; Candida infection; Pulmonary pain | Drug dose omission by device; Dysphonia |
| Prednisolone | 10,281 | 52% | 552 | – | Cataract subcapsular; Eye infection fungal | Endophthalmitis; Eyelid pain |
| Dexamethasone | 10,095 | 93% | 1,763 | – | Steroid diabetes; Jc virus infection; Secondary immunodeficiency | Myelosuppression; Hypoalbuminaemia |
| Hydrocortisone | 9,343 | 91% | 2,383 | – | Duodenal ulcer perforation; Wound infection; Drug tolerance decreased | Hand deformity; Helicobacter infection |
| Methylprednisolone | 7,959 | 85% | 1,003 | – | – | Immunodeficiency; Coeliac disease |
| Deflazacort (Emflaza) | 6,356 | 51% | 306 | – | Weight increased; Influenza; Increased appetite | Abnormal behaviour; Anger |
| Fluocinonide | 5,565 | 43% | 259 | boxed | Psoriasis; Pruritus; Dermatitis atopic | Chronic kidney disease; Eczema |
| Desonide | 4,949 | 55% | 195 | – | – | – |
| Fluocinolone Acetonide | 3,734 | 40% | 69 | – | Dermatitis atopic; Glaucoma; Eczema | Circumstance or information capable of leading to medication error; Needle issue |
| Fluorometholone | 3,150 | 51% | 292 | – | Eye pain; Eye irritation; Ear infection | Glossodynia; Autoimmune disorder |
| Prednisolone | 2,446 | 87% | 461 | – | Osteoporosis; Skin haemorrhage; Eating disorder | Wheezing; Acute hepatic failure |
| Fluocinolone Acetonide | 544 | 9% | 0 | – | Dry skin; Skin irritation; Dermatitis | Erythema; Skin burning sensation |
| Fluorometholone | 262 | 39% | 8 | – | Eye pain; Eye irritation | – |
Class-wide signals (flagged in at least 17 of 33 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Deep vein thrombosis postoperative | 20/33 | 184.3 | 13,360 | 0/20 members' labels |
| Lupus vulgaris | 19/33 | 178.6 | 7,956 | 0/19 members' labels |
| Adjustment disorder with depressed mood | 19/33 | 120.6 | 10,329 | 0/19 members' labels |
| Facet joint syndrome | 17/33 | 150.4 | 16,912 | 0/17 members' labels |
| Mycobacterium chelonae infection | 17/33 | 81.4 | 2,419 | 0/17 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Anticipatory anxiety | Desoximetasone | 98 | 632.9 | Not in label — unassessed |
| Congenital hiatus hernia | Budesonide | 129 | 504.9 | Not in label — unassessed |
| Tenosynovitis stenosans | Methylprednisolone | 79 | 434.0 | Likely indication confounding |
| Systemic lupus erythematosus | Desoximetasone | 8,263 | 338.4 | Not in label — unassessed |
| Mite allergy | Budesonide | 300 | 320.2 | Not in label — unassessed |
| Macular degeneration | Desonide | 787 | 299.8 | No label text to screen |
| Porphyria acute | Hydrocortisone | 159 | 292.3 | Not in label — unassessed |
| Arachnoiditis | Methylprednisolone | 63 | 264.0 | Not in label — unassessed |
| Corneal epithelium defect | Prednisolone | 62 | 246.8 | Likely indication confounding |
| Allergy to chemicals | Methylprednisolone | 105 | 242.7 | Likely indication confounding |
| Pulmonary vasculitis | Budesonide | 201 | 220.6 | Labeled (related wording) |
| Total lung capacity abnormal | Budesonide | 140 | 209.0 | Not in label — unassessed |
| Eosinophilic bronchitis | Budesonide | 74 | 206.9 | Likely indication confounding |
| Mycotic allergy | Budesonide | 303 | 201.8 | Not in label — unassessed |
| Coagulation factor deficiency | Budesonide | 55 | 184.5 | Not in label — unassessed |
| Food allergy | Methylprednisolone | 480 | 178.8 | Likely indication confounding |
| Rheumatoid lung | Methylprednisolone | 60 | 175.0 | Likely indication confounding |
| Personality disorder | Methylprednisolone | 152 | 161.2 | Not in label — unassessed |
| Tenosynovitis | Methylprednisolone | 159 | 160.7 | Likely indication confounding |
| Malignant melanoma stage 0 | Budesonide | 55 | 156.3 | Not in label — unassessed |
| Drug delivery system issue | Budesonide | 132 | 152.4 | Not in label — unassessed |
| Bronchopulmonary aspergillosis allergic | Budesonide | 269 | 149.0 | Likely indication confounding |
| Rheumatoid nodule | Methylprednisolone | 139 | 138.4 | Likely indication confounding |
| Scleritis | Methylprednisolone | 78 | 135.3 | Not in label — unassessed |
| Crepitations | Methylprednisolone | 145 | 133.7 | Not in label — unassessed |
Common questions
Which corticosteroid has the most FDA adverse event reports?
Prednisone has the most FAERS co-reports in this class (499,794), followed by Dexamethasone (294,871). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across corticosteroid drugs?
Reaction terms flagged in at least half of the 33 members include deep vein thrombosis postoperative, lupus vulgaris, adjustment disorder with depressed mood, facet joint syndrome, mycobacterium chelonae infection. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.