What the label lists and what reports show
Fludrocortisone side effects
Fludrocortisone's FDA label lists its adverse reactions in its own words. FAERS holds 2,184 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (156 reports).
- Generic listed
Check it at the source: the fludrocortisone FDA label on DailyMed (effective October 29, 2024, Zydus Lifesciences Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis. When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however, the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid. Musculoskeletal –muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures. …
Source: FDA drug label, Zydus Lifesciences Limited, effective October 29, 2024 (SPL set 6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,184 reports list fludrocortisone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 263 are coded as a death and 867 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fludrocortisone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions