Drug
Efinaconazole
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 | Aspiration | 150 | 152.3 | 165.0 | signal |
| 2 | Sputum Discoloured | 121 | 140.7 | 150.0 | signal |
| 3 | Obstructive Airways Disorder | 121 | 118.9 | 126.7 | signal |
| 4 | Blood Test Abnormal | 140 | 109.3 | 117.7 | signal |
| 5 | Pulmonary Fibrosis | 125 | 71.4 | 76.3 | signal |
| 6 | Pulmonary Mass | 94 | 69.0 | 72.5 | signal |
| 7 | Transaminases Increased | 139 | 68.3 | 73.5 | signal |
| 8 | Liver Function Test Increased | 120 | 61.4 | 65.4 | signal |
| 9 | Haemoptysis | 122 | 47.5 | 50.7 | signal |
| 10 | Full Blood Count Abnormal | 40 | 41.3 | 42.2 | signal |
| 11 | Hypercholesterolaemia | 36 | 41.0 | 41.7 | signal |
| 12 | Hyperlipidaemia | 44 | 40.0 | 40.9 | signal |
| 13 | Hypoxia | 120 | 37.2 | 39.6 | signal |
| 14 | Lower Respiratory Tract Infection | 152 | 36.5 | 39.5 | signal |
| 15 | Upper Respiratory Tract Infection | 152 | 35.8 | 38.8 | signal |
| 16 | Micturition Urgency | 37 | 35.5 | 36.2 | signal |
| 17 | Incorrect Route Of Product Administration | 52 | 33.7 | 34.6 | signal |
| 18 | Bacterial Infection | 53 | 31.0 | 31.9 | signal |
| 19 | Ulcer | 45 | 30.7 | 31.4 | signal |
| 20 | Application Site Pain | 60 | 29.6 | 30.6 | signal |
| 21 | Gout | 44 | 26.6 | 27.2 | signal |
| 22 | End Stage Renal Disease | 44 | 26.0 | 26.6 | signal |
| 23 | Appendicitis | 22 | 25.7 | 26.0 | signal |
| 24 | Blood Creatinine Increased | 148 | 24.6 | 26.6 | signal |
| 25 | Neuralgia | 52 | 23.3 | 23.9 | signal |
| 26 | Ventricular Fibrillation | 23 | 22.4 | 22.7 | signal |
| 27 | Pleural Effusion | 122 | 21.8 | 23.2 | signal |
| 28 | Joint Injury | 41 | 20.8 | 21.3 | signal |
| 29 | Wheezing | 113 | 20.8 | 22.0 | signal |
| 30 | Application Site Erythema | 50 | 20.6 | 21.2 | signal |
| 31 | Multiple Organ Dysfunction Syndrome | 49 | 19.1 | 19.5 | signal |
| 32 | Musculoskeletal Stiffness | 152 | 18.8 | 20.4 | signal |
| 33 | Gastrooesophageal Reflux Disease | 133 | 18.0 | 19.3 | signal |
| 34 | Product Packaging Quantity Issue | 18 | 17.9 | 18.1 | signal |
| 35 | Intervertebral Disc Degeneration | 15 | 17.5 | 17.6 | signal |
| 36 | Blister | 89 | 17.3 | 18.0 | signal |
| 37 | Cardiogenic Shock | 22 | 16.7 | 16.9 | signal |
| 38 | Oedema Peripheral | 170 | 15.1 | 16.5 | signal |
| 39 | Asthma | 154 | 14.9 | 16.1 | signal |
| 40 | Coronary Artery Disease | 40 | 14.2 | 14.5 | signal |
| 41 | Cardiovascular Disorder | 33 | 14.0 | 14.2 | signal |
| 42 | Brain Fog | 18 | 13.4 | 13.5 | signal |
| 43 | Blood Pressure Fluctuation | 28 | 12.6 | 12.8 | signal |
| 44 | Application Site Irritation | 14 | 12.2 | 12.3 | signal |
| 45 | Immunodeficiency | 16 | 11.8 | 11.9 | signal |
| 46 | Rotator Cuff Syndrome | 14 | 11.8 | 11.9 | signal |
| 47 | Transient Ischaemic Attack | 36 | 11.5 | 11.7 | signal |
| 48 | Drug Effect Incomplete | 39 | 11.5 | 11.7 | signal |
| 49 | Insurance Issue | 15 | 11.0 | 11.0 | signal |
| 50 | Blood Pressure Systolic Increased | 19 | 10.5 | 10.6 | signal |
| 51 | Chronic Obstructive Pulmonary Disease | 50 | 10.4 | 10.7 | signal |
| 52 | Application Site Rash | 13 | 10.2 | 10.3 | signal |
| 53 | General Physical Health Deterioration | 108 | 10.2 | 10.8 | signal |
| 54 | Drug Administered At Inappropriate Site | 10 | 10.1 | 10.2 | signal |
| 55 | Tremor | 154 | 10.1 | 10.8 | signal |
| 56 | Application Site Pruritus | 21 | 10.0 | 10.1 | signal |
| 57 | Inability To Afford Medication | 9 | 9.9 | 10.0 | signal |
| 58 | Apathy | 13 | 9.7 | 9.8 | signal |
| 59 | Drug Hypersensitivity | 173 | 9.7 | 10.5 | signal |
| 60 | Sciatica | 14 | 9.6 | 9.6 | signal |
| 61 | Swelling | 82 | 9.5 | 9.9 | signal |
| 62 | Hyponatraemia | 49 | 9.5 | 9.7 | signal |
| 63 | Anaemia | 162 | 9.2 | 10.0 | signal |
| 64 | Eructation | 16 | 9.1 | 9.2 | signal |
| 65 | Liver Disorder | 37 | 9.1 | 9.2 | signal |
| 66 | Stress | 59 | 8.9 | 9.2 | signal |
| 67 | Bone Disorder | 15 | 8.9 | 8.9 | signal |
| 68 | Dermatitis Contact | 9 | 8.6 | 8.6 | signal |
| 69 | Ascites | 23 | 8.5 | 8.6 | signal |
| 70 | Body Temperature Increased | 15 | 8.0 | 8.0 | signal |
| 71 | Mouth Ulceration | 15 | 7.7 | 7.8 | signal |
| 72 | Feeding Disorder | 14 | 7.6 | 7.7 | signal |
| 73 | Sleep Disorder | 48 | 7.4 | 7.6 | signal |
| 74 | Diabetes Mellitus | 51 | 7.2 | 7.4 | signal |
| 75 | Abdominal Pain Upper | 136 | 7.2 | 7.7 | signal |
| 76 | Constipation | 142 | 7.1 | 7.6 | signal |
| 77 | Secretion Discharge | 8 | 7.0 | 7.1 | signal |
| 78 | Lung Disorder | 31 | 6.9 | 7.0 | signal |
| 79 | Fungal Infection | 21 | 6.8 | 6.9 | signal |
| 80 | Hypersomnia | 18 | 6.8 | 6.9 | signal |
| 81 | Thrombosis | 48 | 6.5 | 6.6 | signal |
| 82 | Frequent Bowel Movements | 16 | 6.5 | 6.5 | signal |
| 83 | Tenderness | 6 | 6.2 | 6.3 | signal |
| 84 | Cough | 158 | 6.1 | 6.6 | signal |
| 85 | Intentional Product Misuse | 48 | 6.0 | 6.1 | signal |
| 86 | Product Dose Omission Issue | 157 | 6.0 | 6.4 | signal |
| 87 | Product Administered At Inappropriate Site | 10 | 6.0 | 6.0 | signal |
| 88 | Product Prescribing Error | 13 | 6.0 | 6.0 | signal |
| 89 | Asthenia | 201 | 5.8 | 6.4 | signal |
| 90 | Dermatitis | 11 | 5.8 | 5.8 | signal |
| 91 | Skin Fissures | 10 | 5.7 | 5.8 | signal |
| 92 | Disease Recurrence | 25 | 5.7 | 5.7 | signal |
| 93 | Pulmonary Embolism | 50 | 5.7 | 5.8 | signal |
| 94 | Femur Fracture | 16 | 5.6 | 5.6 | signal |
| 95 | Product Use Issue | 94 | 5.5 | 5.7 | signal |
| 96 | Skin Exfoliation | 41 | 5.4 | 5.4 | signal |
| 97 | Muscle Atrophy | 6 | 5.2 | 5.2 | signal |
| 98 | Erythema | 95 | 5.0 | 5.2 | signal |
| 99 | Burning Sensation | 32 | 5.0 | 5.0 | signal |
| 100 | Economic Problem | 7 | 4.9 | 4.9 | signal |
| 101 | Skin Disorder | 15 | 4.9 | 4.9 | signal |
| 102 | Mass | 6 | 4.6 | 4.7 | signal |
| 103 | Accidental Exposure To Product | 42 | 4.6 | 4.6 | signal |
| 104 | Mood Swings | 13 | 4.4 | 4.4 | signal |
| 105 | Lactic Acidosis | 13 | 4.4 | 4.4 | signal |
| 106 | Rash Macular | 14 | 4.4 | 4.4 | signal |
| 107 | Eye Irritation | 22 | 4.3 | 4.3 | signal |
| 108 | Drug Level Decreased | 4 | 4.2 | 4.3 | signal |
| 109 | Incorrect Drug Administration Duration | 11 | 4.2 | 4.2 | signal |
| 110 | Drug Administration Error | 12 | 4.2 | 4.2 | signal |
| 111 | Red Blood Cell Sedimentation Rate Increased | 4 | 3.9 | 3.9 | signal |
| 112 | Product Quality Issue | 48 | 3.9 | 3.9 | signal |
| 113 | No Adverse Event | 62 | 3.8 | 3.9 | signal |
| 114 | Skin Irritation | 16 | 3.8 | 3.8 | signal |
| 115 | Medication Error | 19 | 3.7 | 3.7 | signal |
| 116 | Arthropathy | 19 | 3.7 | 3.7 | signal |
| 117 | Anhedonia | 9 | 3.7 | 3.7 | signal |
| 118 | Local Swelling | 6 | 3.7 | 3.7 | signal |
| 119 | Device Leakage | 14 | 3.6 | 3.6 | signal |
| 120 | Extra Dose Administered | 13 | 3.5 | 3.6 | signal |
| 121 | Inflammatory Bowel Disease | 3 | 3.3 | 3.3 | no signal |
| 122 | Incorrect Product Administration Duration | 6 | 3.2 | 3.2 | signal |
| 123 | Device Delivery System Issue | 7 | 2.9 | 2.9 | signal |
| 124 | Therapy Interrupted | 17 | 2.7 | 2.7 | signal |
| 125 | Expired Product Administered | 8 | 2.6 | 2.6 | signal |
| 126 | Drug Dose Omission | 40 | 2.6 | 2.6 | signal |
| 127 | Product Availability Issue | 5 | 2.4 | 2.4 | no signal |
| 128 | Exposure Via Skin Contact | 5 | 2.4 | 2.4 | no signal |
| 129 | Device Issue | 18 | 2.2 | 2.2 | signal |
| 130 | Product Physical Issue | 4 | 2.2 | 2.2 | no signal |
| 131 | Drug Dispensing Error | 3 | 2.1 | 2.1 | no signal |
| 132 | Wrong Technique In Product Usage Process | 33 | 1.8 | 1.8 | no signal |
| 133 | Incorrect Route Of Drug Administration | 5 | 1.5 | 1.5 | no signal |
| 134 | Skin Burning Sensation | 9 | 1.4 | 1.4 | no signal |
| 135 | Dermatitis Atopic | 5 | 1.1 | 1.1 | no signal |
| 136 | Device Breakage | 3 | 0.8 | 0.8 | no signal |