Drug · FAERS side-effect profile with label screen
Fludrocortisone side effects: what 2,184 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Fludrocortisone Acetate (Fludrocortisone Acetate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,184 reports · 72% serious · 263 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
FDA label, Indications and Usage
What it is
DESCRIPTION Fludrocortisone Acetate Tablets USP, 0.1 mg contain fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 7Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 27
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 68 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Orthostatic hypotension (dizziness on standing) | 40 | 22.0 16.2–30.0ROR 22.4 · χ² 782 / p 3e-172 | 21.8 EB05 16.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 | no trial data cached |
| Adrenal insufficiency | 26 | 20.9 14.2–30.6ROR 21.1 · χ² 472 / p 7e-105 | 20.5 EB05 14.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 16.3 | no trial data cached |
| Infusion site pain | 21 | 15.8 10.3–24.2ROR 15.9 · χ² 276 / p 2e-62 | 15.3 EB05 10.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=16 · ♀ 100% (drug 52%) · 71% consumer | no trial data cached |
| Blood potassium decreased | 32 | 10.2 7.2–14.4ROR 10.4 · χ² 257 / p 4e-58 | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Hospice care | 10 | 9.8 5.3–18.1ROR 9.8 · χ² 70 / p 3e-17 | 7.7 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Hypomagnesaemia | 13 | 9.0 5.2–15.5ROR 9.0 · χ² 85 / p 2e-20 | 7.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Dermatitis contact | 10 | 8.5 4.6–15.7ROR 8.5 · χ² 58 / p 1e-14 | 6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Insurance issue | 13 | 8.4 4.9–14.5ROR 8.4 · χ² 78 / p 6e-19 | 6.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Blood pressure fluctuation | 21 | 8.4 5.5–12.8ROR 8.5 · χ² 129 / p 3e-30 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Ataxia | 10 | 8.1 4.3–15.0ROR 8.1 · χ² 55 / p 6e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Eosinophilia | 14 | 7.7 4.6–13.0ROR 7.7 · χ² 75 / p 2e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Neuralgia | 19 | 7.5 4.8–11.8ROR 7.6 · χ² 101 / p 4e-24 | 6.6 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Tooth infection | 10 | 7.3 3.9–13.5ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Presyncope (near-fainting) | 18 | 7.1 4.5–11.3ROR 7.2 · χ² 89 / p 2e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Hallucination (hallucinations) | 55 | 7.0 5.4–9.1ROR 7.2 · χ² 280 / p 4e-63 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Blood pressure decreased | 48 | 6.9 5.3–9.2ROR 7.1 · χ² 239 / p 3e-54 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Dyskinesia (involuntary movements) | 27 | 6.4 4.4–9.3ROR 6.5 · χ² 118 / p 1e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Heart rate irregular | 15 | 6.3 3.8–10.5ROR 6.4 · χ² 62 / p 2e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 | no trial data cached |
| Syncope (fainting) | 63 | 6.0 4.7–7.7ROR 6.2 · χ² 261 / p 5e-59 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Dysarthria (slurred speech) | 22 | 5.6 3.7–8.5ROR 5.7 · χ² 79 / p 3e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 29% (drug 52%) | no trial data cached |
| Mental status changes | 16 | 5.5 3.4–9.0ROR 5.6 · χ² 55 / p 6e-14 | 4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Serotonin syndrome | 11 | 5.5 3.1–10.0ROR 5.5 · χ² 36 / p 8e-10 | 4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Dementia | 16 | 5.5 3.4–9.0ROR 5.5 · χ² 55 / p 7e-14 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Speech disorder | 30 | 5.5 3.9–7.8ROR 5.6 · χ² 106 / p 3e-25 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 26% (drug 52%) | no trial data cached |
| Hallucination, visual | 12 | 5.5 3.1–9.7ROR 5.5 · χ² 40 / p 1e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| International normalised ratio increased | 16 | 5.3 3.3–8.7ROR 5.4 · χ² 52 / p 3e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Gastroenteritis viral | 10 | 5.3 2.9–9.8ROR 5.3 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Loss of consciousness | 70 | 5.2 4.2–6.6ROR 5.4 · χ² 237 / p 7e-54 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Blood pressure abnormal | 10 | 4.8 2.6–9.0ROR 4.9 · χ² 27 / p 1e-7 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.0 | no trial data cached |
| Disorientation | 19 | 4.6 2.9–7.2ROR 4.6 · χ² 50 / p 8e-13 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Pallor | 13 | 4.6 2.7–7.9ROR 4.6 · χ² 33 / p 5e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Fall | 151 | 4.4 3.7–5.1ROR 4.6 · χ² 394 / p 6e-88 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Fungal infection | 15 | 4.3 2.6–7.2ROR 4.3 · χ² 35 / p 2e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Hip fracture | 14 | 4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Seizure | 46 | 3.8 2.9–5.1ROR 3.9 · χ² 95 / p 1e-22 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 19 | 3.8 2.4–5.9ROR 3.8 · χ² 36 / p 1e-9 | 3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 13 | 3.7 2.1–6.3ROR 3.7 · χ² 23 / p 9e-7 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Illness | 38 | 3.6 2.6–5.0ROR 3.7 · χ² 70 / p 3e-17 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · ♀ 81% (drug 52%) | no trial data cached |
| Blood glucose decreased | 17 | 3.4 2.1–5.4ROR 3.4 · χ² 26 / p 1e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | no trial data cached |
| Cerebrovascular accident (stroke) | 59 | 3.3 2.6–4.3ROR 3.4 · χ² 95 / p 1e-22 | 3.3 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fall | 151 | 4.4 3.7–5.1ROR 4.6 · χ² 394 / p 6e-88 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Loss of consciousness | 70 | 5.2 4.2–6.6ROR 5.4 · χ² 237 / p 7e-54 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Syncope (fainting) | 63 | 6.0 4.7–7.7ROR 6.2 · χ² 261 / p 5e-59 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cerebrovascular accident (stroke) | 59 | 3.3 2.6–4.3ROR 3.4 · χ² 95 / p 1e-22 | 3.3 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Hallucination (hallucinations) | 55 | 7.0 5.4–9.1ROR 7.2 · χ² 280 / p 4e-63 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Blood pressure decreased | 48 | 6.9 5.3–9.2ROR 7.1 · χ² 239 / p 3e-54 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Seizure | 46 | 3.8 2.9–5.1ROR 3.9 · χ² 95 / p 1e-22 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 40 | 22.0 16.2–30.0ROR 22.4 · χ² 782 / p 3e-172 | 21.8 EB05 16.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 | no trial data cached |
| Illness | 38 | 3.6 2.6–5.0ROR 3.7 · χ² 70 / p 3e-17 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · ♀ 81% (drug 52%) | no trial data cached |
| Blood potassium decreased | 32 | 10.2 7.2–14.4ROR 10.4 · χ² 257 / p 4e-58 | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Speech disorder | 30 | 5.5 3.9–7.8ROR 5.6 · χ² 106 / p 3e-25 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 26% (drug 52%) | no trial data cached |
| Dyskinesia (involuntary movements) | 27 | 6.4 4.4–9.3ROR 6.5 · χ² 118 / p 1e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Adrenal insufficiency | 26 | 20.9 14.2–30.6ROR 21.1 · χ² 472 / p 7e-105 | 20.5 EB05 14.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 16.3 | no trial data cached |
| Dysarthria (slurred speech) | 22 | 5.6 3.7–8.5ROR 5.7 · χ² 79 / p 3e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 29% (drug 52%) | no trial data cached |
| Blood pressure fluctuation | 21 | 8.4 5.5–12.8ROR 8.5 · χ² 129 / p 3e-30 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Orthostatic hypotension — n=40, PRR 22.0
- Infusion site pain — n=21, PRR 15.8
- Hallucination — n=55, PRR 7.0
- Dyskinesia — n=27, PRR 6.4
- Syncope — n=63, PRR 6.0
- Dysarthria — n=22, PRR 5.6
- Speech disorder — n=30, PRR 5.5
- Loss of consciousness — n=70, PRR 5.2
- Fall — n=151, PRR 4.4
- Cerebrovascular accident — n=59, PRR 3.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Fludrocortisone?
In FDA FAERS, the most frequently co-reported reaction terms for Fludrocortisone are fall, loss of consciousness, syncope, cerebrovascular accident, hallucination, blood pressure decreased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Fludrocortisone have an FDA boxed warning?
No. The FDA label retrieved for Fludrocortisone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fludrocortisone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2cd3965d-cab9-a97c-db61-7d03ced154f3, effective 20260108; matched on
openfda.generic_name.exact:"FLUDROCORTISONE ACETATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 108 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.