Drug
Miconazole
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 | International Normalised Ratio Increased | 127 | 38.5 | 40.6 | signal |
| 2 | Oral Candidiasis | 38 | 25.4 | 25.8 | signal |
| 3 | Drug Interaction | 238 | 13.0 | 14.4 | signal |
| 4 | Haematuria | 48 | 12.2 | 12.4 | signal |
| 5 | Candida Infection | 21 | 10.9 | 11.0 | signal |
| 6 | Full Blood Count Abnormal | 13 | 10.7 | 10.8 | signal |
| 7 | Haematoma | 30 | 10.0 | 10.1 | signal |
| 8 | Vaginal Discharge | 11 | 9.5 | 9.6 | signal |
| 9 | Eosinophilia | 19 | 9.5 | 9.5 | signal |
| 10 | Cytomegalovirus Infection | 17 | 8.9 | 8.9 | signal |
| 11 | Stevens-johnson Syndrome | 21 | 8.2 | 8.3 | signal |
| 12 | Pericardial Effusion | 21 | 7.9 | 8.0 | signal |
| 13 | Application Site Pain | 19 | 7.5 | 7.6 | signal |
| 14 | Premature Baby | 26 | 7.5 | 7.6 | signal |
| 15 | Clostridium Difficile Colitis | 9 | 7.4 | 7.4 | signal |
| 16 | Upper Gastrointestinal Haemorrhage | 14 | 7.2 | 7.2 | signal |
| 17 | End Stage Renal Disease | 15 | 7.1 | 7.1 | signal |
| 18 | Hyponatraemia | 45 | 7.0 | 7.1 | signal |
| 19 | Toxic Epidermal Necrolysis | 12 | 6.9 | 6.9 | signal |
| 20 | Hypokalaemia | 36 | 6.8 | 6.9 | signal |
| 21 | Acute Respiratory Failure | 15 | 6.8 | 6.8 | signal |
| 22 | Economic Problem | 12 | 6.8 | 6.8 | signal |
| 23 | Adrenal Insufficiency | 9 | 6.5 | 6.6 | signal |
| 24 | Fungal Infection | 25 | 6.5 | 6.6 | signal |
| 25 | Haematemesis | 19 | 6.5 | 6.5 | signal |
| 26 | Hepatic Cytolysis | 9 | 6.4 | 6.4 | signal |
| 27 | Pharyngeal Swelling | 7 | 6.4 | 6.4 | signal |
| 28 | Conjunctivitis | 13 | 6.1 | 6.2 | signal |
| 29 | Drug Level Increased | 11 | 5.8 | 5.8 | signal |
| 30 | Glomerular Filtration Rate Decreased | 8 | 5.7 | 5.8 | signal |
| 31 | Pericarditis | 11 | 5.7 | 5.8 | signal |
| 32 | Urosepsis | 6 | 5.7 | 5.7 | signal |
| 33 | Lip Swelling | 21 | 5.5 | 5.5 | signal |
| 34 | Orthostatic Hypotension | 11 | 5.5 | 5.5 | signal |
| 35 | Skin Infection | 7 | 5.5 | 5.5 | signal |
| 36 | Multi-organ Failure | 11 | 5.4 | 5.5 | signal |
| 37 | Acute Respiratory Distress Syndrome | 11 | 5.4 | 5.4 | signal |
| 38 | Mouth Ulceration | 13 | 5.4 | 5.4 | signal |
| 39 | Cellulitis | 31 | 5.3 | 5.4 | signal |
| 40 | Drug Exposure During Pregnancy | 21 | 5.3 | 5.3 | signal |
| 41 | Chronic Kidney Disease | 46 | 5.2 | 5.3 | signal |
| 42 | Haemorrhage Intracranial | 9 | 5.2 | 5.2 | signal |
| 43 | Hypotonia | 6 | 5.2 | 5.2 | signal |
| 44 | Agranulocytosis | 11 | 5.2 | 5.2 | signal |
| 45 | Dermatitis | 12 | 5.0 | 5.1 | signal |
| 46 | Petechiae | 6 | 5.0 | 5.0 | signal |
| 47 | Pancytopenia | 31 | 4.8 | 4.9 | signal |
| 48 | Melaena | 12 | 4.7 | 4.7 | signal |
| 49 | Increased Tendency To Bruise | 5 | 4.7 | 4.7 | signal |
| 50 | Liver Function Test Abnormal | 15 | 4.5 | 4.5 | signal |
| 51 | Cyanosis | 8 | 4.4 | 4.4 | signal |
| 52 | Cytopenia | 6 | 4.4 | 4.4 | signal |
| 53 | Disseminated Intravascular Coagulation | 7 | 4.3 | 4.3 | signal |
| 54 | Anhedonia | 13 | 4.3 | 4.3 | signal |
| 55 | Application Site Pruritus | 11 | 4.2 | 4.2 | signal |
| 56 | Myelodysplastic Syndrome | 7 | 4.2 | 4.2 | signal |
| 57 | Coagulopathy | 8 | 4.2 | 4.2 | signal |
| 58 | Pulmonary Hypertension | 10 | 4.2 | 4.2 | signal |
| 59 | Hypocalcaemia | 9 | 4.1 | 4.2 | signal |
| 60 | Swelling Face | 31 | 4.1 | 4.2 | signal |
| 61 | Hereditary Angioedema | 5 | 4.1 | 4.1 | signal |
| 62 | Fluid Overload | 7 | 4.1 | 4.1 | signal |
| 63 | Serotonin Syndrome | 9 | 4.1 | 4.1 | signal |
| 64 | Breast Cancer Metastatic | 5 | 4.0 | 4.1 | signal |
| 65 | Rectal Haemorrhage | 20 | 4.0 | 4.1 | signal |
| 66 | Gastrointestinal Haemorrhage | 39 | 4.0 | 4.1 | signal |
| 67 | Thrombocytopenia | 50 | 3.9 | 4.0 | signal |
| 68 | Rash Erythematous | 21 | 3.9 | 3.9 | signal |
| 69 | Basal Cell Carcinoma | 7 | 3.9 | 3.9 | signal |
| 70 | Pancreatitis Acute | 10 | 3.9 | 3.9 | signal |
| 71 | Bone Marrow Failure | 9 | 3.8 | 3.8 | signal |
| 72 | Oral Discomfort | 6 | 3.7 | 3.8 | signal |
| 73 | Rash Pruritic | 23 | 3.7 | 3.7 | signal |
| 74 | Cerebral Haemorrhage | 15 | 3.6 | 3.7 | signal |
| 75 | Hospice Care | 4 | 3.5 | 3.5 | signal |
| 76 | Pneumocystis Jirovecii Pneumonia | 4 | 3.5 | 3.5 | signal |
| 77 | Burning Sensation | 28 | 3.5 | 3.5 | signal |
| 78 | Febrile Neutropenia | 26 | 3.4 | 3.4 | signal |
| 79 | Acute Myeloid Leukaemia | 6 | 3.3 | 3.4 | signal |
| 80 | Angioedema | 17 | 3.3 | 3.4 | signal |
| 81 | Hallucination, Auditory | 6 | 3.3 | 3.3 | signal |
| 82 | Pharyngitis Streptococcal | 4 | 3.2 | 3.2 | signal |
| 83 | Dementia | 10 | 3.1 | 3.1 | signal |
| 84 | Intestinal Perforation | 4 | 3.1 | 3.1 | no signal |
| 85 | Paranoia | 6 | 3.0 | 3.0 | signal |
| 86 | Pregnancy | 7 | 3.0 | 3.0 | signal |
| 87 | Application Site Irritation | 4 | 2.8 | 2.8 | no signal |
| 88 | Foetal Exposure During Pregnancy | 26 | 2.8 | 2.8 | signal |
| 89 | Drug Resistance | 8 | 2.7 | 2.7 | signal |
| 90 | Tuberculosis | 4 | 2.7 | 2.7 | no signal |
| 91 | Convulsion | 18 | 2.7 | 2.7 | signal |
| 92 | Metastases To Bone | 5 | 2.7 | 2.7 | no signal |
| 93 | Vaginal Haemorrhage | 13 | 2.7 | 2.7 | signal |
| 94 | Drug Level Decreased | 3 | 2.5 | 2.6 | no signal |
| 95 | Exposure During Pregnancy | 18 | 2.5 | 2.5 | signal |
| 96 | Anosmia | 4 | 2.4 | 2.4 | no signal |
| 97 | Sedation | 7 | 2.3 | 2.3 | signal |
| 98 | Cytokine Release Syndrome | 5 | 2.3 | 2.3 | no signal |
| 99 | Product Physical Issue | 5 | 2.2 | 2.2 | no signal |
| 100 | Activities Of Daily Living Impaired | 5 | 2.2 | 2.2 | no signal |
| 101 | Abnormal Weight Gain | 3 | 2.1 | 2.1 | no signal |
| 102 | Drug Toxicity | 3 | 1.9 | 1.9 | no signal |
| 103 | Drug Prescribing Error | 4 | 1.8 | 1.8 | no signal |
| 104 | Plasma Cell Myeloma | 7 | 1.6 | 1.6 | no signal |
| 105 | Extrapyramidal Disorder | 4 | 1.4 | 1.4 | no signal |