Drug
Fluorometholone
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 | Autoimmune Disorder | 107 | 75.2 | 77.8 | signal |
| 2 | Helicobacter Infection | 107 | 70.6 | 73.0 | signal |
| 3 | Folliculitis | 107 | 69.6 | 72.1 | signal |
| 4 | Bursitis | 99 | 55.0 | 56.8 | signal |
| 5 | Hypercholesterolaemia | 75 | 52.6 | 53.8 | signal |
| 6 | Hand Deformity | 96 | 49.2 | 50.7 | signal |
| 7 | Foot Deformity | 79 | 47.7 | 48.9 | signal |
| 8 | Pemphigus | 82 | 44.2 | 45.3 | signal |
| 9 | Laryngitis | 68 | 41.9 | 42.8 | signal |
| 10 | Wound Infection | 63 | 38.8 | 39.6 | signal |
| 11 | Glossodynia | 109 | 32.6 | 33.7 | signal |
| 12 | Pericarditis | 78 | 31.3 | 32.1 | signal |
| 13 | Joint Range Of Motion Decreased | 61 | 30.5 | 31.1 | signal |
| 14 | Treatment Failure | 364 | 29.6 | 33.4 | signal |
| 15 | Sleep Disorder Due To A General Medical Condition | 71 | 29.3 | 30.0 | signal |
| 16 | Hepatic Cirrhosis | 82 | 29.3 | 30.1 | signal |
| 17 | Sciatica | 65 | 27.4 | 27.9 | signal |
| 18 | Eye Pain | 221 | 26.7 | 28.7 | signal |
| 19 | Intraocular Pressure Increased | 50 | 26.0 | 26.4 | signal |
| 20 | Synovitis | 70 | 25.9 | 26.5 | signal |
| 21 | Ocular Discomfort | 40 | 24.6 | 24.9 | signal |
| 22 | Fibromyalgia | 87 | 23.9 | 24.6 | signal |
| 23 | Irritable Bowel Syndrome | 74 | 23.1 | 23.7 | signal |
| 24 | Weight Fluctuation | 36 | 23.1 | 23.3 | signal |
| 25 | Obesity | 54 | 22.6 | 23.0 | signal |
| 26 | Pulmonary Fibrosis | 64 | 22.4 | 22.8 | signal |
| 27 | Impaired Healing | 108 | 22.0 | 22.7 | signal |
| 28 | Ear Infection | 87 | 21.9 | 22.5 | signal |
| 29 | Eye Inflammation | 29 | 20.5 | 20.7 | signal |
| 30 | Frequent Bowel Movements | 81 | 20.1 | 20.6 | signal |
| 31 | Eye Irritation | 166 | 19.9 | 20.9 | signal |
| 32 | Wound | 82 | 19.7 | 20.2 | signal |
| 33 | Lower Limb Fracture | 55 | 19.2 | 19.5 | signal |
| 34 | Liver Injury | 67 | 18.5 | 18.9 | signal |
| 35 | Eye Discharge | 28 | 18.3 | 18.4 | signal |
| 36 | Delirium | 91 | 17.6 | 18.0 | signal |
| 37 | Photophobia | 43 | 15.4 | 15.6 | signal |
| 38 | Prescribed Overdose | 44 | 15.2 | 15.4 | signal |
| 39 | Ocular Hyperaemia | 105 | 15.0 | 15.5 | signal |
| 40 | Lacrimation Increased | 67 | 15.0 | 15.3 | signal |
| 41 | Systemic Lupus Erythematosus | 78 | 14.7 | 15.1 | signal |
| 42 | Type 2 Diabetes Mellitus | 74 | 14.6 | 14.9 | signal |
| 43 | Arthropathy | 121 | 14.5 | 15.0 | signal |
| 44 | Blood Cholesterol Increased | 99 | 14.2 | 14.6 | signal |
| 45 | Laboratory Test Abnormal | 61 | 13.8 | 14.0 | signal |
| 46 | Hip Arthroplasty | 30 | 13.2 | 13.3 | signal |
| 47 | Psoriatic Arthropathy | 78 | 12.9 | 13.2 | signal |
| 48 | Colitis Ulcerative | 86 | 12.9 | 13.2 | signal |
| 49 | Night Sweats | 62 | 12.8 | 13.1 | signal |
| 50 | Lower Respiratory Tract Infection | 85 | 12.5 | 12.8 | signal |
| 51 | Blister | 104 | 12.4 | 12.8 | signal |
| 52 | Conjunctivitis | 34 | 12.3 | 12.5 | signal |
| 53 | Discomfort | 112 | 12.3 | 12.7 | signal |
| 54 | Dry Eye | 89 | 12.2 | 12.6 | signal |
| 55 | Ill-defined Disorder | 107 | 11.7 | 12.1 | signal |
| 56 | Joint Dislocation | 18 | 11.4 | 11.5 | signal |
| 57 | Road Traffic Accident | 71 | 11.3 | 11.5 | signal |
| 58 | White Blood Cell Count Increased | 65 | 11.3 | 11.5 | signal |
| 59 | Glaucoma | 32 | 11.1 | 11.2 | signal |
| 60 | Pregnancy | 33 | 10.9 | 11.0 | signal |
| 61 | Osteoarthritis | 69 | 10.8 | 11.0 | signal |
| 62 | Eye Swelling | 60 | 10.8 | 11.0 | signal |
| 63 | Rectal Haemorrhage | 69 | 10.7 | 10.9 | signal |
| 64 | Eye Pruritus | 52 | 10.5 | 10.7 | signal |
| 65 | Liver Disorder | 68 | 10.2 | 10.4 | signal |
| 66 | Lung Disorder | 75 | 10.2 | 10.4 | signal |
| 67 | Infusion Related Reaction | 101 | 10.2 | 10.5 | signal |
| 68 | Stomatitis | 91 | 10.0 | 10.3 | signal |
| 69 | Hepatic Enzyme Increased | 100 | 9.8 | 10.1 | signal |
| 70 | Osteoporosis | 60 | 9.7 | 9.9 | signal |
| 71 | Red Blood Cell Sedimentation Rate Increased | 16 | 9.6 | 9.7 | signal |
| 72 | Inflammation | 74 | 9.6 | 9.8 | signal |
| 73 | Knee Arthroplasty | 30 | 9.6 | 9.7 | signal |
| 74 | Dry Mouth | 116 | 9.5 | 9.9 | signal |
| 75 | Eye Infection | 16 | 9.5 | 9.5 | signal |
| 76 | Feeling Hot | 84 | 9.1 | 9.3 | signal |
| 77 | Musculoskeletal Pain | 72 | 9.1 | 9.3 | signal |
| 78 | Maternal Exposure During Pregnancy | 120 | 9.1 | 9.4 | signal |
| 79 | Amnesia | 88 | 9.0 | 9.2 | signal |
| 80 | Pancreatitis | 71 | 8.9 | 9.1 | signal |
| 81 | Uveitis | 18 | 8.9 | 8.9 | signal |
| 82 | Gastrointestinal Disorder | 113 | 8.5 | 8.8 | signal |
| 83 | Joint Stiffness | 33 | 8.4 | 8.5 | signal |
| 84 | Prescribed Underdose | 25 | 8.3 | 8.4 | signal |
| 85 | Oedema | 67 | 8.2 | 8.4 | signal |
| 86 | Respiratory Disorder | 36 | 8.0 | 8.1 | signal |
| 87 | Madarosis | 14 | 8.0 | 8.0 | signal |
| 88 | Arthritis | 94 | 7.9 | 8.2 | signal |
| 89 | Contusion | 112 | 7.8 | 8.0 | signal |
| 90 | Wheezing | 67 | 7.5 | 7.7 | signal |
| 91 | Injury | 80 | 7.5 | 7.7 | signal |
| 92 | Eye Disorder | 37 | 7.5 | 7.6 | signal |
| 93 | Contraindicated Product Administered | 34 | 7.5 | 7.6 | signal |
| 94 | Asthma | 126 | 7.5 | 7.8 | signal |
| 95 | Loss Of Personal Independence In Daily Activities | 53 | 7.4 | 7.5 | signal |
| 96 | Hepatomegaly | 11 | 7.4 | 7.4 | signal |
| 97 | Eyelid Oedema | 13 | 7.4 | 7.4 | signal |
| 98 | Photosensitivity Reaction | 18 | 7.3 | 7.3 | signal |
| 99 | Retinal Detachment | 10 | 7.2 | 7.3 | signal |
| 100 | Cataract | 59 | 6.6 | 6.7 | signal |
| 101 | Mobility Decreased | 71 | 6.6 | 6.7 | signal |
| 102 | Visual Impairment | 115 | 6.2 | 6.4 | signal |
| 103 | Visual Acuity Reduced | 31 | 6.2 | 6.2 | signal |
| 104 | Vision Blurred | 123 | 6.0 | 6.2 | signal |
| 105 | Sinusitis | 92 | 6.0 | 6.1 | signal |
| 106 | Blood Urine Present | 17 | 5.9 | 6.0 | signal |
| 107 | Dyspepsia | 85 | 5.8 | 5.9 | signal |
| 108 | Infusion Site Pain | 11 | 5.7 | 5.8 | signal |
| 109 | Skin Laceration | 9 | 5.5 | 5.6 | signal |
| 110 | Swelling | 77 | 5.5 | 5.6 | signal |
| 111 | Product Packaging Quantity Issue | 9 | 5.5 | 5.5 | signal |
| 112 | General Physical Health Deterioration | 92 | 5.3 | 5.5 | signal |
| 113 | Taste Disorder | 16 | 5.3 | 5.3 | signal |
| 114 | Rheumatoid Arthritis | 90 | 5.3 | 5.4 | signal |
| 115 | Therapy Non-responder | 35 | 5.2 | 5.3 | signal |
| 116 | Muscular Weakness | 86 | 5.0 | 5.2 | signal |
| 117 | Joint Swelling | 91 | 5.0 | 5.1 | signal |
| 118 | Hepatic Steatosis | 14 | 5.0 | 5.0 | signal |
| 119 | Intervertebral Disc Degeneration | 7 | 5.0 | 5.0 | signal |
| 120 | Therapeutic Product Effect Decreased | 33 | 5.0 | 5.0 | signal |
| 121 | Confusional State | 119 | 4.9 | 5.0 | signal |
| 122 | Musculoskeletal Stiffness | 64 | 4.9 | 4.9 | signal |
| 123 | Abdominal Discomfort | 122 | 4.9 | 5.0 | signal |
| 124 | Infection | 103 | 4.8 | 4.9 | signal |
| 125 | Hypoaesthesia | 107 | 4.8 | 4.9 | signal |
| 126 | Product Use Complaint | 11 | 4.7 | 4.7 | signal |
| 127 | Hypersensitivity | 130 | 4.7 | 4.8 | signal |
| 128 | Chest Pain | 128 | 4.6 | 4.7 | signal |
| 129 | Migraine | 65 | 4.6 | 4.6 | signal |
| 130 | Tooth Abscess | 7 | 4.6 | 4.6 | signal |
| 131 | Ear Pain | 13 | 4.5 | 4.5 | signal |
| 132 | Toothache | 12 | 4.4 | 4.4 | signal |
| 133 | C-reactive Protein Increased | 24 | 4.4 | 4.4 | signal |
| 134 | Iron Deficiency Anaemia | 6 | 4.3 | 4.4 | signal |
| 135 | Back Injury | 7 | 4.3 | 4.3 | signal |
| 136 | Alopecia | 127 | 4.3 | 4.4 | signal |
| 137 | Peripheral Swelling | 99 | 4.3 | 4.4 | signal |
| 138 | Erythema Multiforme | 6 | 4.3 | 4.3 | signal |
| 139 | Exposure During Pregnancy | 40 | 4.3 | 4.3 | signal |
| 140 | Drug Hypersensitivity | 124 | 4.3 | 4.4 | signal |
| 141 | Seasonal Allergy | 9 | 4.2 | 4.3 | signal |
| 142 | Gait Inability | 21 | 4.2 | 4.2 | signal |
| 143 | Sleep Apnoea Syndrome | 12 | 4.2 | 4.2 | signal |
| 144 | Rotator Cuff Syndrome | 8 | 4.1 | 4.1 | signal |
| 145 | Mouth Ulceration | 13 | 4.1 | 4.1 | signal |
| 146 | Dermatitis Contact | 7 | 4.1 | 4.1 | signal |
| 147 | Vitreous Floaters | 6 | 4.1 | 4.1 | signal |
| 148 | Nasopharyngitis | 111 | 4.0 | 4.1 | signal |
| 149 | Sleep Disorder | 42 | 4.0 | 4.0 | signal |
| 150 | Poor Quality Product Administered | 6 | 3.9 | 3.9 | signal |
| 151 | Adrenal Insufficiency | 7 | 3.9 | 3.9 | signal |
| 152 | Gait Disturbance | 112 | 3.9 | 4.0 | signal |
| 153 | Decreased Appetite | 135 | 3.9 | 4.0 | signal |
| 154 | Depression | 133 | 3.9 | 4.0 | signal |
| 155 | Basal Cell Carcinoma | 9 | 3.8 | 3.8 | signal |
| 156 | Memory Impairment | 78 | 3.8 | 3.8 | signal |
| 157 | Pharyngitis | 7 | 3.7 | 3.7 | signal |
| 158 | Underdose | 40 | 3.6 | 3.7 | signal |
| 159 | Muscle Spasms | 99 | 3.6 | 3.7 | signal |
| 160 | Diplopia | 14 | 3.6 | 3.6 | signal |
| 161 | Sneezing | 12 | 3.6 | 3.6 | signal |
| 162 | Oral Pain | 12 | 3.6 | 3.6 | signal |
| 163 | Dermatitis | 11 | 3.5 | 3.5 | signal |
| 164 | Skin Fissures | 10 | 3.5 | 3.5 | signal |
| 165 | Abdominal Pain Upper | 108 | 3.5 | 3.6 | signal |
| 166 | Swollen Tongue | 16 | 3.4 | 3.4 | signal |
| 167 | Anxiety | 143 | 3.3 | 3.4 | signal |
| 168 | Febrile Neutropenia | 33 | 3.3 | 3.3 | signal |
| 169 | Blindness Unilateral | 7 | 3.3 | 3.3 | signal |
| 170 | Eyelid Ptosis | 5 | 3.3 | 3.3 | signal |
| 171 | Blindness | 20 | 3.3 | 3.3 | signal |
| 172 | Ear Discomfort | 5 | 3.3 | 3.3 | signal |
| 173 | Muscle Spasticity | 6 | 3.2 | 3.2 | signal |
| 174 | Paraesthesia | 76 | 3.2 | 3.3 | signal |
| 175 | Choking | 9 | 3.1 | 3.1 | signal |
| 176 | Weight Increased | 103 | 3.1 | 3.1 | signal |
| 177 | Skin Disorder | 15 | 3.0 | 3.0 | signal |
| 178 | Quality Of Life Decreased | 6 | 3.0 | 3.0 | signal |
| 179 | Urticaria | 72 | 2.9 | 2.9 | signal |
| 180 | Oral Discomfort | 6 | 2.9 | 2.9 | signal |
| 181 | Squamous Cell Carcinoma | 4 | 2.8 | 2.8 | no signal |
| 182 | Cytopenia | 5 | 2.8 | 2.8 | signal |
| 183 | Wrist Fracture | 5 | 2.8 | 2.8 | signal |
| 184 | Skin Haemorrhage | 6 | 2.8 | 2.8 | signal |
| 185 | Spinal Operation | 5 | 2.7 | 2.8 | no signal |
| 186 | Coeliac Disease | 4 | 2.7 | 2.7 | no signal |
| 187 | Arthralgia | 167 | 2.7 | 2.8 | signal |
| 188 | Speech Disorder | 21 | 2.7 | 2.7 | signal |
| 189 | Poor Venous Access | 4 | 2.6 | 2.6 | no signal |
| 190 | Hallucination, Auditory | 6 | 2.5 | 2.5 | signal |
| 191 | Drug Administered At Inappropriate Site | 4 | 2.5 | 2.5 | no signal |
| 192 | Cerebral Infarction | 9 | 2.4 | 2.5 | signal |
| 193 | Dermatitis Atopic | 18 | 2.4 | 2.4 | signal |
| 194 | Stevens-johnson Syndrome | 8 | 2.4 | 2.4 | signal |
| 195 | Eczema | 18 | 2.4 | 2.4 | signal |
| 196 | Product Administration Error | 7 | 2.3 | 2.3 | signal |
| 197 | Interstitial Lung Disease | 16 | 2.2 | 2.2 | signal |
| 198 | Blood Thyroid Stimulating Hormone Increased | 3 | 2.2 | 2.2 | no signal |
| 199 | Skin Cancer | 7 | 2.2 | 2.2 | no signal |
| 200 | Cytokine Release Syndrome | 6 | 2.1 | 2.1 | no signal |
| 201 | Inflammatory Bowel Disease | 3 | 2.0 | 2.0 | no signal |
| 202 | Eye Haemorrhage | 4 | 2.0 | 2.0 | no signal |
| 203 | Ovarian Cyst | 3 | 2.0 | 2.0 | no signal |
| 204 | Breast Cancer Metastatic | 3 | 1.9 | 1.9 | no signal |
| 205 | No Adverse Event | 49 | 1.8 | 1.9 | no signal |
| 206 | Drug Resistance | 7 | 1.8 | 1.8 | no signal |
| 207 | Dry Skin | 35 | 1.8 | 1.8 | no signal |
| 208 | Schizophrenia | 3 | 1.6 | 1.6 | no signal |
| 209 | Incorrect Product Administration Duration | 5 | 1.6 | 1.6 | no signal |
| 210 | Product Preparation Error | 5 | 1.6 | 1.6 | no signal |
| 211 | Application Site Irritation | 3 | 1.6 | 1.6 | no signal |
| 212 | Device Use Issue | 4 | 1.5 | 1.5 | no signal |
| 213 | Device Delivery System Issue | 6 | 1.5 | 1.5 | no signal |
| 214 | Application Site Pain | 5 | 1.5 | 1.5 | no signal |
| 215 | Wrong Technique In Product Usage Process | 45 | 1.5 | 1.5 | no signal |
| 216 | Hair Texture Abnormal | 3 | 1.5 | 1.5 | no signal |
| 217 | Expired Product Administered | 7 | 1.4 | 1.4 | no signal |
| 218 | Acne | 16 | 1.4 | 1.4 | no signal |
| 219 | Product Substitution Issue | 12 | 1.4 | 1.4 | no signal |
| 220 | Product Complaint | 5 | 1.3 | 1.3 | no signal |
| 221 | Accidental Exposure To Product | 20 | 1.3 | 1.3 | no signal |
| 222 | Multiple Sclerosis | 9 | 1.2 | 1.2 | no signal |
| 223 | Multiple Fractures | 3 | 1.2 | 1.2 | no signal |
| 224 | Product Quality Issue | 24 | 1.2 | 1.2 | no signal |
| 225 | Drug Prescribing Error | 3 | 1.0 | 1.0 | no signal |
| 226 | Application Site Erythema | 4 | 1.0 | 1.0 | no signal |
| 227 | Device Breakage | 5 | 0.8 | 0.8 | no signal |
| 228 | Incorrect Dose Administered By Device | 3 | 0.8 | 0.8 | no signal |
| 229 | Device Leakage | 4 | 0.6 | 0.6 | no signal |