Drug
Fluocinolone Acetonide
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 | Intraocular Pressure Increased | 203 | 90.2 | 95.3 | signal |
| 2 | Device Failure | 151 | 56.4 | 58.8 | signal |
| 3 | Circumstance Or Information Capable Of Leading To Medication Error | 141 | 23.7 | 24.6 | signal |
| 4 | Device Dislocation | 157 | 20.4 | 21.2 | signal |
| 5 | Product Administration Error | 70 | 19.8 | 20.1 | signal |
| 6 | Needle Issue | 97 | 19.1 | 19.6 | signal |
| 7 | Glaucoma | 59 | 17.2 | 17.5 | signal |
| 8 | Vitreous Floaters | 26 | 15.0 | 15.1 | signal |
| 9 | Retinal Detachment | 22 | 13.5 | 13.5 | signal |
| 10 | Sleep Disorder Due To A General Medical Condition | 36 | 12.5 | 12.6 | signal |
| 11 | Eye Inflammation | 20 | 11.9 | 12.0 | signal |
| 12 | Scratch | 19 | 10.3 | 10.4 | signal |
| 13 | Complication Of Device Insertion | 32 | 9.7 | 9.8 | signal |
| 14 | Dermatitis Atopic | 86 | 9.7 | 9.9 | signal |
| 15 | Visual Acuity Reduced | 40 | 6.7 | 6.8 | signal |
| 16 | Blindness | 46 | 6.3 | 6.4 | signal |
| 17 | Dermatitis | 23 | 6.2 | 6.3 | signal |
| 18 | Eczema | 55 | 6.1 | 6.2 | signal |
| 19 | Scab | 12 | 5.9 | 6.0 | signal |
| 20 | Uveitis | 14 | 5.8 | 5.8 | signal |
| 21 | Psoriasis | 133 | 5.7 | 5.9 | signal |
| 22 | Skin Haemorrhage | 14 | 5.4 | 5.5 | signal |
| 23 | Skin Fissures | 18 | 5.4 | 5.4 | signal |
| 24 | Skin Exfoliation | 77 | 5.2 | 5.3 | signal |
| 25 | Ear Discomfort | 9 | 4.9 | 4.9 | signal |
| 26 | Conjunctivitis | 16 | 4.9 | 4.9 | signal |
| 27 | Cataract | 51 | 4.8 | 4.9 | signal |
| 28 | Erythema Multiforme | 8 | 4.8 | 4.8 | signal |
| 29 | Discomfort | 52 | 4.8 | 4.9 | signal |
| 30 | Blindness Unilateral | 12 | 4.8 | 4.8 | signal |
| 31 | Seasonal Allergy | 12 | 4.8 | 4.8 | signal |
| 32 | Eye Pain | 46 | 4.7 | 4.7 | signal |
| 33 | Eye Haemorrhage | 11 | 4.6 | 4.6 | signal |
| 34 | Eye Infection | 9 | 4.5 | 4.5 | signal |
| 35 | Skin Discolouration | 35 | 4.3 | 4.3 | signal |
| 36 | No Adverse Event | 132 | 4.2 | 4.3 | signal |
| 37 | Product Dose Omission Issue | 209 | 4.1 | 4.3 | signal |
| 38 | Ear Pain | 14 | 4.0 | 4.1 | signal |
| 39 | Vitamin D Deficiency | 7 | 4.0 | 4.0 | signal |
| 40 | Skin Disorder | 23 | 3.9 | 3.9 | signal |
| 41 | Off Label Use | 598 | 3.9 | 4.4 | signal |
| 42 | Sleep Disorder | 48 | 3.9 | 3.9 | signal |
| 43 | Secretion Discharge | 8 | 3.6 | 3.6 | signal |
| 44 | Photophobia | 12 | 3.6 | 3.6 | signal |
| 45 | Visual Impairment | 79 | 3.6 | 3.7 | signal |
| 46 | Skin Reaction | 9 | 3.6 | 3.6 | signal |
| 47 | Eye Pruritus | 21 | 3.6 | 3.6 | signal |
| 48 | Application Site Pain | 14 | 3.6 | 3.6 | signal |
| 49 | Impaired Quality Of Life | 9 | 3.5 | 3.5 | signal |
| 50 | Dermatitis Contact | 7 | 3.5 | 3.5 | signal |
| 51 | Therapy Non-responder | 27 | 3.4 | 3.4 | signal |
| 52 | Ear Infection | 16 | 3.4 | 3.4 | signal |
| 53 | Dry Skin | 76 | 3.2 | 3.3 | signal |
| 54 | Pruritus | 216 | 3.2 | 3.3 | signal |
| 55 | Dermatitis Allergic | 7 | 3.2 | 3.2 | signal |
| 56 | Skin Cancer | 12 | 3.1 | 3.1 | signal |
| 57 | Sinus Disorder | 11 | 3.1 | 3.1 | signal |
| 58 | Photosensitivity Reaction | 9 | 3.1 | 3.1 | signal |
| 59 | Rash Macular | 19 | 3.1 | 3.1 | signal |
| 60 | Pain Of Skin | 14 | 2.9 | 2.9 | signal |
| 61 | Oral Herpes | 10 | 2.9 | 2.9 | signal |
| 62 | Ocular Hyperaemia | 24 | 2.9 | 2.9 | signal |
| 63 | Bladder Disorder | 5 | 2.8 | 2.8 | signal |
| 64 | Hypotonia | 5 | 2.8 | 2.8 | signal |
| 65 | Eye Disorder | 16 | 2.7 | 2.7 | signal |
| 66 | Application Site Pruritus | 11 | 2.7 | 2.7 | signal |
| 67 | Device Difficult To Use | 32 | 2.7 | 2.7 | signal |
| 68 | Injection Site Discolouration | 6 | 2.7 | 2.7 | signal |
| 69 | Drug Dose Omission By Device | 36 | 2.6 | 2.7 | signal |
| 70 | Therapeutic Response Decreased | 28 | 2.6 | 2.6 | signal |
| 71 | Device Use Issue | 8 | 2.6 | 2.6 | signal |
| 72 | Pharyngitis Streptococcal | 5 | 2.6 | 2.6 | no signal |
| 73 | Tooth Infection | 6 | 2.6 | 2.6 | signal |
| 74 | Sars-cov-2 Test Positive | 6 | 2.5 | 2.5 | signal |
| 75 | Lacrimation Increased | 13 | 2.4 | 2.4 | signal |
| 76 | Dry Eye | 21 | 2.4 | 2.4 | signal |
| 77 | Product Quality Issue | 58 | 2.4 | 2.4 | signal |
| 78 | Carpal Tunnel Syndrome | 6 | 2.4 | 2.4 | no signal |
| 79 | Rash Erythematous | 20 | 2.4 | 2.4 | signal |
| 80 | Increased Appetite | 8 | 2.4 | 2.4 | signal |
| 81 | Drug Effect Less Than Expected | 6 | 2.4 | 2.4 | no signal |
| 82 | Pharyngeal Swelling | 4 | 2.3 | 2.3 | no signal |
| 83 | Skin Irritation | 19 | 2.3 | 2.3 | signal |
| 84 | Product Dose Omission In Error | 11 | 2.3 | 2.3 | signal |
| 85 | Hepatitis C | 5 | 2.3 | 2.3 | no signal |
| 86 | Cyst | 5 | 2.3 | 2.3 | no signal |
| 87 | Device Issue | 35 | 2.3 | 2.3 | signal |
| 88 | Syringe Issue | 7 | 2.2 | 2.2 | no signal |
| 89 | Psoriatic Arthropathy | 16 | 2.2 | 2.2 | signal |
| 90 | Eye Irritation | 22 | 2.2 | 2.2 | signal |
| 91 | Dry Throat | 4 | 2.2 | 2.2 | no signal |
| 92 | Eye Discharge | 4 | 2.2 | 2.2 | no signal |
| 93 | Product Use Complaint | 6 | 2.2 | 2.2 | no signal |
| 94 | Product Odour Abnormal | 4 | 2.2 | 2.2 | no signal |
| 95 | Breast Pain | 4 | 2.1 | 2.1 | no signal |
| 96 | Device Defective | 6 | 2.1 | 2.1 | no signal |
| 97 | Hair Texture Abnormal | 5 | 2.1 | 2.1 | no signal |
| 98 | Ocular Discomfort | 4 | 2.1 | 2.1 | no signal |
| 99 | Alopecia | 69 | 2.0 | 2.0 | no signal |
| 100 | Irritability | 20 | 1.9 | 1.9 | no signal |
| 101 | Acne | 25 | 1.8 | 1.8 | no signal |
| 102 | Device Malfunction | 22 | 1.8 | 1.8 | no signal |
| 103 | Brain Neoplasm | 3 | 1.8 | 1.8 | no signal |
| 104 | Expired Product Administered | 10 | 1.7 | 1.7 | no signal |
| 105 | Hunger | 4 | 1.7 | 1.7 | no signal |
| 106 | Poor Quality Product Administered | 3 | 1.6 | 1.6 | no signal |
| 107 | Prostatic Specific Antigen Increased | 4 | 1.6 | 1.6 | no signal |
| 108 | Hereditary Angioedema | 3 | 1.6 | 1.6 | no signal |
| 109 | Therapeutic Response Shortened | 9 | 1.6 | 1.6 | no signal |
| 110 | Product Administered At Inappropriate Site | 5 | 1.5 | 1.5 | no signal |
| 111 | Suicidal Ideation | 25 | 1.5 | 1.5 | no signal |
| 112 | Suicide Attempt | 16 | 1.5 | 1.5 | no signal |
| 113 | Madarosis | 3 | 1.4 | 1.4 | no signal |
| 114 | Skin Burning Sensation | 17 | 1.3 | 1.3 | no signal |
| 115 | Hair Colour Changes | 3 | 1.3 | 1.3 | no signal |
| 116 | Injection Site Irritation | 3 | 1.3 | 1.3 | no signal |
| 117 | Injection Site Reaction | 16 | 1.3 | 1.3 | no signal |
| 118 | Anorexia | 3 | 1.3 | 1.3 | no signal |
| 119 | Dysmenorrhoea | 3 | 1.3 | 1.3 | no signal |
| 120 | Device Breakage | 9 | 1.3 | 1.3 | no signal |
| 121 | Injection Site Swelling | 17 | 1.3 | 1.3 | no signal |
| 122 | Product Dose Omission | 14 | 1.2 | 1.2 | no signal |
| 123 | Drug Prescribing Error | 4 | 1.2 | 1.2 | no signal |
| 124 | Extra Dose Administered | 8 | 1.1 | 1.1 | no signal |
| 125 | Extrapyramidal Disorder | 5 | 1.1 | 1.1 | no signal |
| 126 | Bone Loss | 3 | 1.1 | 1.1 | no signal |
| 127 | Injection Site Pain | 57 | 1.1 | 1.1 | no signal |
| 128 | Exposure Via Skin Contact | 4 | 1.0 | 1.0 | no signal |
| 129 | Tardive Dyskinesia | 5 | 1.0 | 1.0 | no signal |
| 130 | Injection Site Pruritus | 11 | 0.9 | 0.9 | no signal |
| 131 | Injection Site Urticaria | 4 | 0.9 | 0.9 | no signal |
| 132 | Multiple Sclerosis | 7 | 0.8 | 0.8 | no signal |
| 133 | Product Preparation Error | 3 | 0.8 | 0.8 | no signal |
| 134 | Injection Site Bruising | 11 | 0.8 | 0.8 | no signal |
| 135 | Drug Effective For Unapproved Indication | 4 | 0.8 | 0.8 | no signal |
| 136 | Injection Site Mass | 5 | 0.8 | 0.8 | no signal |
| 137 | Injection Site Erythema | 15 | 0.7 | 0.7 | no signal |
| 138 | Application Site Erythema | 3 | 0.6 | 0.6 | no signal |
| 139 | Breast Cancer Female | 3 | 0.6 | 0.6 | no signal |
| 140 | Accidental Exposure To Product | 9 | 0.5 | 0.5 | no signal |