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Drug

Fluocinolone Acetonide

140 flagged reaction(s) · 4,367 total co-reports · max PRR 90.2
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