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Drug

Difluprednate

103 flagged reaction(s) · 3,542 total co-reports · max PRR 237.0
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 528 237.0 275.2 signal
2 Eye Inflammation 94 55.6 57.0 signal
3 Uveitis 97 40.0 41.0 signal
4 Therapy Partial Responder 105 38.8 39.9 signal
5 Ocular Discomfort 49 25.0 25.4 signal
6 Eye Pain 231 23.2 24.6 signal
7 Glaucoma 69 19.9 20.2 signal
8 Blindness Unilateral 50 19.7 19.9 signal
9 Vitreous Floaters 31 17.6 17.8 signal
10 Eye Infection 35 17.3 17.4 signal
11 Eye Irritation 167 16.6 17.3 signal
12 Photophobia 53 15.7 15.9 signal
13 Cataract 158 14.8 15.4 signal
14 Eye Discharge 27 14.6 14.7 signal
15 Retinal Detachment 24 14.5 14.5 signal
16 Lacrimation Increased 57 10.6 10.7 signal
17 Product Availability Issue 41 10.1 10.2 signal
18 Ocular Hyperaemia 85 10.1 10.3 signal
19 Blindness 74 10.1 10.2 signal
20 Eye Swelling 65 9.7 9.9 signal
21 Product Administration Error 30 8.3 8.4 signal
22 Eye Haemorrhage 20 8.3 8.3 signal
23 Eye Disorder 48 8.1 8.2 signal
24 Vision Blurred 186 7.5 7.9 signal
25 End Stage Renal Disease 24 7.2 7.2 signal
26 Visual Acuity Reduced 42 6.9 7.0 signal
27 Visual Impairment 153 6.9 7.1 signal
28 Chronic Kidney Disease 87 6.3 6.4 signal
29 Eye Pruritus 36 6.0 6.1 signal
30 Dry Eye 47 5.4 5.4 signal
31 Product Use Complaint 14 5.0 5.0 signal
32 Eyelid Oedema 10 4.7 4.7 signal
33 Macular Degeneration 10 4.6 4.6 signal
34 Autoimmune Disorder 8 4.6 4.6 signal
35 Rebound Effect 9 4.4 4.4 signal
36 Treatment Failure 65 4.4 4.4 signal
37 Product Packaging Issue 7 4.2 4.2 signal
38 Post Procedural Complication 13 3.7 3.7 signal
39 Adrenal Insufficiency 8 3.7 3.7 signal
40 Iron Deficiency Anaemia 6 3.6 3.6 signal
41 Intervertebral Disc Degeneration 6 3.6 3.6 signal
42 Erythema Multiforme 6 3.6 3.6 signal
43 Product Packaging Quantity Issue 7 3.5 3.5 signal
44 Scar 11 3.5 3.6 signal
45 Seasonal Allergy 9 3.5 3.5 signal
46 Blood Lactate Dehydrogenase Increased 10 3.5 3.5 signal
47 Oral Pain 14 3.4 3.5 signal
48 Inflammation 31 3.3 3.4 signal
49 Sinus Congestion 8 3.3 3.3 signal
50 Expired Product Administered 18 3.0 3.0 signal
51 Nephropathy 5 2.9 2.9 signal
52 Mouth Ulceration 11 2.9 2.9 signal
53 Drug Eruption 9 2.8 2.8 signal
54 Hip Fracture 16 2.8 2.8 signal
55 Eyelid Ptosis 5 2.7 2.7 no signal
56 Dermatitis 10 2.7 2.7 signal
57 Paranoia 8 2.6 2.6 signal
58 Blood Pressure Systolic Increased 9 2.5 2.5 signal
59 Stevens-johnson Syndrome 10 2.5 2.5 signal
60 Nerve Injury 5 2.5 2.5 no signal
61 Rash Papular 10 2.5 2.5 signal
62 Conjunctivitis 8 2.4 2.4 signal
63 Movement Disorder 14 2.4 2.4 signal
64 Device Defective 7 2.4 2.4 signal
65 Deformity 4 2.4 2.4 no signal
66 Accident 5 2.3 2.3 no signal
67 Inappropriate Antidiuretic Hormone Secretion 4 2.2 2.2 no signal
68 Drug Reaction With Eosinophilia And Systemic Symptoms 10 2.2 2.2 signal
69 Hypoacusis 16 2.1 2.1 signal
70 Intestinal Perforation 4 2.0 2.0 no signal
71 Product Quality Issue 47 1.9 1.9 no signal
72 Skin Haemorrhage 5 1.9 1.9 no signal
73 Product Dose Omission 22 1.8 1.8 no signal
74 Leukaemia 3 1.8 1.8 no signal
75 No Adverse Event 56 1.7 1.8 no signal
76 Mydriasis 4 1.7 1.7 no signal
77 Knee Operation 3 1.7 1.7 no signal
78 Full Blood Count Decreased 6 1.6 1.6 no signal
79 Toxic Skin Eruption 3 1.6 1.6 no signal
80 Device Use Issue 5 1.6 1.6 no signal
81 Therapy Interrupted 19 1.5 1.5 no signal
82 Systemic Lupus Erythematosus 9 1.4 1.4 no signal
83 Diabetic Ketoacidosis 6 1.4 1.4 no signal
84 Inappropriate Schedule Of Drug Administration 18 1.4 1.4 no signal
85 Acne 19 1.4 1.4 no signal
86 Device Breakage 9 1.3 1.3 no signal
87 Product Administered At Inappropriate Site 4 1.2 1.2 no signal
88 Prostatic Specific Antigen Increased 3 1.2 1.2 no signal
89 Device Dislocation 9 1.1 1.1 no signal
90 Incorrect Dose Administered 46 1.1 1.1 no signal
91 Drug Effect Decreased 11 1.1 1.1 no signal
92 Injury Associated With Device 4 1.1 1.1 no signal
93 Incorrect Product Administration Duration 4 1.1 1.1 no signal
94 Bone Density Decreased 6 1.0 1.0 no signal
95 Accidental Exposure To Product 18 1.0 1.0 no signal
96 Device Issue 13 0.8 0.8 no signal
97 Incorrect Drug Administration Duration 4 0.8 0.8 no signal
98 Needle Issue 4 0.8 0.8 no signal
99 Injection Site Bruising 11 0.8 0.8 no signal
100 Gastric Cancer 3 0.6 0.6 no signal
101 Wrong Technique In Drug Usage Process 4 0.6 0.6 no signal
102 Injection Site Haemorrhage 8 0.6 0.6 no signal
103 Device Difficult To Use 3 0.3 0.3 no signal