Drug
Difluprednate
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 |