Drug
Fludrocortisone Acetate
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Orthostatic Hypotension | 40 | 22.0 | 22.4 | signal |
| 2 | Adrenal Insufficiency | 26 | 20.9 | 21.1 | signal |
| 3 | Infusion Site Pain | 21 | 15.8 | 15.9 | signal |
| 4 | Blood Potassium Decreased | 32 | 10.2 | 10.4 | signal |
| 5 | Hospice Care | 10 | 9.8 | 9.8 | signal |
| 6 | Autoimmune Disorder | 9 | 9.0 | 9.1 | signal |
| 7 | Hypomagnesaemia | 13 | 9.0 | 9.0 | signal |
| 8 | Dermatitis Contact | 10 | 8.5 | 8.5 | signal |
| 9 | Insurance Issue | 13 | 8.4 | 8.4 | signal |
| 10 | Blood Pressure Fluctuation | 21 | 8.4 | 8.5 | signal |
| 11 | Weight Fluctuation | 9 | 8.3 | 8.3 | signal |
| 12 | Ataxia | 10 | 8.1 | 8.1 | signal |
| 13 | Eosinophilia | 14 | 7.7 | 7.7 | signal |
| 14 | Neuralgia | 19 | 7.5 | 7.6 | signal |
| 15 | Tooth Infection | 10 | 7.3 | 7.3 | signal |
| 16 | Clostridium Difficile Colitis | 8 | 7.2 | 7.3 | signal |
| 17 | Wrist Fracture | 9 | 7.2 | 7.2 | signal |
| 18 | Presyncope | 18 | 7.1 | 7.2 | signal |
| 19 | Skin Laceration | 8 | 7.1 | 7.1 | signal |
| 20 | Hallucination | 55 | 7.0 | 7.2 | signal |
| 21 | Blood Pressure Decreased | 48 | 6.9 | 7.1 | signal |
| 22 | Ligament Sprain | 7 | 6.8 | 6.8 | signal |
| 23 | Ventricular Extrasystoles | 7 | 6.5 | 6.5 | signal |
| 24 | Dyskinesia | 27 | 6.4 | 6.5 | signal |
| 25 | Heart Rate Irregular | 15 | 6.3 | 6.4 | signal |
| 26 | Urosepsis | 6 | 6.2 | 6.3 | signal |
| 27 | Syncope | 63 | 6.0 | 6.2 | signal |
| 28 | Parkinsonism | 6 | 5.9 | 5.9 | signal |
| 29 | Hypoaesthesia Oral | 9 | 5.7 | 5.8 | signal |
| 30 | Dysarthria | 22 | 5.6 | 5.7 | signal |
| 31 | Mental Status Changes | 16 | 5.5 | 5.6 | signal |
| 32 | Serotonin Syndrome | 11 | 5.5 | 5.5 | signal |
| 33 | Dementia | 16 | 5.5 | 5.5 | signal |
| 34 | Speech Disorder | 30 | 5.5 | 5.6 | signal |
| 35 | Hallucination, Visual | 12 | 5.5 | 5.5 | signal |
| 36 | International Normalised Ratio Increased | 16 | 5.3 | 5.4 | signal |
| 37 | Gastroenteritis Viral | 10 | 5.3 | 5.3 | signal |
| 38 | Gastroenteritis | 8 | 5.3 | 5.3 | signal |
| 39 | Loss Of Consciousness | 70 | 5.2 | 5.4 | signal |
| 40 | Ventricular Tachycardia | 9 | 5.2 | 5.2 | signal |
| 41 | Anorexia | 7 | 5.1 | 5.2 | signal |
| 42 | Eye Infection | 6 | 5.1 | 5.1 | signal |
| 43 | Nephropathy | 5 | 5.1 | 5.1 | signal |
| 44 | Fistula | 6 | 5.1 | 5.1 | signal |
| 45 | Spinal Disorder | 5 | 5.1 | 5.1 | signal |
| 46 | Posterior Reversible Encephalopathy Syndrome | 5 | 5.0 | 5.1 | signal |
| 47 | Blood Pressure Abnormal | 10 | 4.8 | 4.9 | signal |
| 48 | Body Temperature Decreased | 5 | 4.8 | 4.8 | signal |
| 49 | Bladder Disorder | 5 | 4.8 | 4.8 | signal |
| 50 | Disorientation | 19 | 4.6 | 4.6 | signal |
| 51 | Pallor | 13 | 4.6 | 4.6 | signal |
| 52 | Impaired Gastric Emptying | 6 | 4.5 | 4.5 | signal |
| 53 | Dystonia | 9 | 4.4 | 4.5 | signal |
| 54 | Fall | 151 | 4.4 | 4.6 | signal |
| 55 | Dental Caries | 5 | 4.3 | 4.4 | signal |
| 56 | Feeding Disorder | 9 | 4.3 | 4.3 | signal |
| 57 | Product Administration Error | 9 | 4.3 | 4.3 | signal |
| 58 | Fungal Infection | 15 | 4.3 | 4.3 | signal |
| 59 | Hip Fracture | 14 | 4.2 | 4.2 | signal |
| 60 | Grand Mal Convulsion | 4 | 4.1 | 4.1 | signal |
| 61 | Leukaemia | 4 | 4.1 | 4.1 | signal |
| 62 | Laceration | 4 | 4.0 | 4.0 | signal |
| 63 | Muscle Rigidity | 5 | 4.0 | 4.0 | signal |
| 64 | Circulatory Collapse | 7 | 3.9 | 3.9 | signal |
| 65 | Coeliac Disease | 4 | 3.9 | 3.9 | signal |
| 66 | Tooth Disorder | 9 | 3.9 | 3.9 | signal |
| 67 | Seizure | 46 | 3.8 | 3.9 | signal |
| 68 | Multi-organ Failure | 7 | 3.8 | 3.8 | signal |
| 69 | Hypoglycaemia | 19 | 3.8 | 3.8 | signal |
| 70 | Ear Discomfort | 4 | 3.8 | 3.8 | signal |
| 71 | Poor Venous Access | 4 | 3.7 | 3.7 | signal |
| 72 | Delusion | 6 | 3.7 | 3.7 | signal |
| 73 | Product Use Complaint | 6 | 3.7 | 3.7 | signal |
| 74 | Ankylosing Spondylitis | 5 | 3.7 | 3.7 | signal |
| 75 | Transient Ischaemic Attack | 13 | 3.7 | 3.7 | signal |
| 76 | Hereditary Angioedema | 4 | 3.7 | 3.7 | signal |
| 77 | Illness | 38 | 3.6 | 3.7 | signal |
| 78 | Sudden Death | 4 | 3.6 | 3.6 | signal |
| 79 | Pharyngitis Streptococcal | 4 | 3.5 | 3.6 | signal |
| 80 | Ocular Discomfort | 4 | 3.5 | 3.5 | signal |
| 81 | Pulmonary Thrombosis | 4 | 3.5 | 3.5 | signal |
| 82 | Musculoskeletal Disorder | 7 | 3.5 | 3.5 | signal |
| 83 | Device Occlusion | 5 | 3.5 | 3.5 | signal |
| 84 | Blood Glucose Decreased | 17 | 3.4 | 3.4 | signal |
| 85 | Cerebrovascular Accident | 59 | 3.3 | 3.4 | signal |
| 86 | Macular Degeneration | 4 | 3.2 | 3.2 | signal |
| 87 | Femur Fracture | 10 | 3.1 | 3.1 | signal |
| 88 | Therapeutic Response Shortened | 9 | 2.7 | 2.7 | signal |
| 89 | Osteonecrosis Of Jaw | 6 | 2.3 | 2.3 | no signal |
| 90 | Cytomegalovirus Infection | 4 | 2.3 | 2.3 | no signal |
| 91 | Tooth Loss | 5 | 2.3 | 2.3 | no signal |
| 92 | Aggression | 12 | 2.3 | 2.3 | signal |
| 93 | Metastases To Central Nervous System | 3 | 2.2 | 2.2 | no signal |
| 94 | Device Use Issue | 4 | 2.2 | 2.2 | no signal |
| 95 | Product Substitution Issue | 13 | 2.2 | 2.2 | signal |
| 96 | Product Physical Issue | 4 | 1.9 | 1.9 | no signal |
| 97 | Device Failure | 3 | 1.9 | 1.9 | no signal |
| 98 | Device Dislocation | 8 | 1.8 | 1.8 | no signal |
| 99 | Device Issue | 15 | 1.6 | 1.7 | no signal |
| 100 | Palmar-plantar Erythrodysaesthesia Syndrome | 4 | 1.6 | 1.6 | no signal |
| 101 | Injection Site Urticaria | 4 | 1.6 | 1.6 | no signal |
| 102 | Drug Effect Incomplete | 6 | 1.6 | 1.6 | no signal |
| 103 | Injection Site Warmth | 3 | 1.4 | 1.4 | no signal |
| 104 | Intentional Drug Misuse | 3 | 1.4 | 1.4 | no signal |
| 105 | Device Breakage | 5 | 1.2 | 1.2 | no signal |
| 106 | Wrong Technique In Device Usage Process | 5 | 1.0 | 1.0 | no signal |
| 107 | Tardive Dyskinesia | 3 | 1.0 | 1.0 | no signal |
| 108 | Device Difficult To Use | 3 | 0.4 | 0.4 | no signal |