OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Olopatadine Hydrochloride Ophthalmic

129 flagged reaction(s) · 3,910 total co-reports · max PRR 126.3
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 Treatment Failure 1,933 126.3 243.2 signal
2 Erythema Multiforme 20 11.3 11.3 signal
3 Seasonal Allergy 25 9.3 9.3 signal
4 Drug Eruption 30 8.9 9.0 signal
5 Infusion Site Pain 20 8.2 8.2 signal
6 Conjunctivitis 24 6.8 6.9 signal
7 Adrenal Insufficiency 15 6.6 6.6 signal
8 Eye Pruritus 40 6.4 6.4 signal
9 Body Temperature Decreased 11 5.8 5.8 signal
10 Hepatic Function Abnormal 40 5.7 5.7 signal
11 Eye Discharge 11 5.6 5.7 signal
12 Eye Infection 12 5.6 5.6 signal
13 Blood Pressure Fluctuation 25 5.4 5.5 signal
14 Ocular Discomfort 10 4.8 4.8 signal
15 Pharyngitis 11 4.6 4.6 signal
16 Eye Irritation 49 4.6 4.6 signal
17 Eye Pain 47 4.5 4.5 signal
18 Disseminated Intravascular Coagulation 12 4.5 4.5 signal
19 Sinusitis 84 4.3 4.4 signal
20 Ligament Sprain 8 4.2 4.3 signal
21 Pulmonary Mass 12 4.2 4.2 signal
22 Ear Infection 21 4.1 4.2 signal
23 Poor Venous Access 8 4.1 4.1 signal
24 Blood Pressure Systolic Increased 15 4.0 4.0 signal
25 Pneumonia Aspiration 19 4.0 4.0 signal
26 Productive Cough 36 4.0 4.0 signal
27 Skin Ulcer 19 3.9 3.9 signal
28 Product Packaging Quantity Issue 8 3.8 3.8 signal
29 Interstitial Lung Disease 35 3.8 3.8 signal
30 Diverticulitis 20 3.8 3.8 signal
31 Viral Infection 24 3.8 3.8 signal
32 Dermatitis Contact 8 3.7 3.7 signal
33 Oral Candidiasis 9 3.6 3.6 signal
34 Pulmonary Arterial Hypertension 10 3.6 3.6 signal
35 Ocular Hyperaemia 31 3.5 3.5 signal
36 Dry Eye 32 3.5 3.5 signal
37 Bacterial Infection 12 3.4 3.4 signal
38 Bronchitis 48 3.4 3.4 signal
39 Injection Site Extravasation 8 3.4 3.4 signal
40 Fungal Infection 21 3.3 3.3 signal
41 Autoimmune Disorder 6 3.3 3.3 signal
42 Myelodysplastic Syndrome 9 3.3 3.3 signal
43 Altered State Of Consciousness 13 3.2 3.2 signal
44 Pneumocystis Jirovecii Pneumonia 6 3.1 3.1 signal
45 Candida Infection 10 3.1 3.1 signal
46 Neutrophil Count Decreased 24 3.1 3.1 signal
47 Neuralgia 14 3.0 3.0 signal
48 Hereditary Angioedema 6 3.0 3.0 signal
49 Secretion Discharge 7 3.0 3.0 signal
50 Blood Lactate Dehydrogenase Increased 9 3.0 3.0 signal
51 Blood Cholesterol Increased 26 2.9 2.9 signal
52 Body Height Decreased 6 2.9 2.9 signal
53 Pharyngitis Streptococcal 6 2.9 2.9 signal
54 Asthma 60 2.8 2.8 signal
55 Tooth Infection 7 2.8 2.8 signal
56 Uveitis 7 2.7 2.7 signal
57 Sinus Congestion 7 2.7 2.7 signal
58 Lacrimation Increased 15 2.6 2.6 signal
59 Stevens-johnson Syndrome 11 2.6 2.6 signal
60 Cerebral Infarction 12 2.6 2.6 signal
61 Drug-induced Liver Injury 15 2.5 2.6 signal
62 Febrile Neutropenia 32 2.5 2.5 signal
63 Rhinorrhoea 31 2.5 2.5 signal
64 Brain Fog 7 2.5 2.5 signal
65 Cytokine Release Syndrome 9 2.5 2.5 signal
66 Localised Infection 11 2.4 2.4 signal
67 Melaena 10 2.4 2.4 signal
68 Product Use Complaint 7 2.4 2.4 signal
69 Prescribed Underdose 9 2.4 2.4 signal
70 Acute Myeloid Leukaemia 7 2.4 2.4 signal
71 Sars-cov-2 Test Positive 6 2.4 2.4 no signal
72 Hypersensitivity 83 2.3 2.4 signal
73 Influenza 50 2.3 2.4 signal
74 Intestinal Perforation 5 2.3 2.3 no signal
75 Nasal Congestion 26 2.3 2.3 signal
76 Scab 5 2.3 2.3 no signal
77 Neoplasm 5 2.3 2.3 no signal
78 Eye Swelling 16 2.3 2.3 signal
79 Device Defective 7 2.3 2.3 no signal
80 Middle Insomnia 8 2.3 2.3 signal
81 Eyelid Oedema 5 2.2 2.2 no signal
82 Infusion Related Reaction 28 2.2 2.2 signal
83 Skin Fissures 8 2.2 2.2 signal
84 Covid-19 Pneumonia 5 2.2 2.2 no signal
85 Eczema 21 2.2 2.2 signal
86 Oral Herpes 8 2.2 2.2 no signal
87 Insurance Issue 6 2.1 2.1 no signal
88 Anaphylactic Reaction 22 2.1 2.1 signal
89 Herpes Zoster 23 2.1 2.1 signal
90 Toxic Skin Eruption 4 2.1 2.1 no signal
91 Initial Insomnia 4 2.1 2.1 no signal
92 Euphoric Mood 4 2.0 2.0 no signal
93 Illness 39 2.0 2.0 signal
94 Blood Glucose Abnormal 7 2.0 2.0 no signal
95 Intentional Dose Omission 10 1.9 1.9 no signal
96 Drug Effect Less Than Expected 5 1.9 1.9 no signal
97 Rebound Effect 4 1.8 1.8 no signal
98 Internal Haemorrhage 4 1.8 1.8 no signal
99 Spinal Operation 4 1.7 1.7 no signal
100 Blood Count Abnormal 5 1.7 1.7 no signal
101 Blood Thyroid Stimulating Hormone Increased 3 1.7 1.7 no signal
102 Therapeutic Response Shortened 10 1.6 1.6 no signal
103 Product Availability Issue 7 1.6 1.6 no signal
104 Injection Site Induration 4 1.6 1.6 no signal
105 Rash Generalised 8 1.6 1.6 no signal
106 Cytomegalovirus Infection 5 1.6 1.6 no signal
107 Cardiac Disorder 27 1.5 1.5 no signal
108 Myelosuppression 9 1.4 1.4 no signal
109 Dermatitis Atopic 13 1.4 1.4 no signal
110 Device Leakage 11 1.4 1.4 no signal
111 Caesarean Section 3 1.3 1.3 no signal
112 Sleep Disorder Due To A General Medical Condition 4 1.3 1.3 no signal
113 Incorrect Product Administration Duration 5 1.3 1.3 no signal
114 Injection Site Discolouration 3 1.3 1.3 no signal
115 Ankylosing Spondylitis 3 1.2 1.2 no signal
116 Malignant Neoplasm Progression 22 1.1 1.1 no signal
117 Expired Product Administered 7 1.1 1.1 no signal
118 Injection Site Pruritus 14 1.1 1.1 no signal
119 Device Failure 3 1.0 1.0 no signal
120 No Adverse Event 34 1.0 1.0 no signal
121 Product Substitution Issue 11 1.0 1.0 no signal
122 Injection Site Swelling 14 1.0 1.0 no signal
123 Injection Site Mass 6 0.9 0.9 no signal
124 Gastric Cancer 4 0.8 0.8 no signal
125 Injection Site Rash 4 0.7 0.7 no signal
126 Device Breakage 5 0.7 0.7 no signal
127 Injection Site Urticaria 3 0.6 0.6 no signal
128 Injection Site Erythema 15 0.6 0.6 no signal
129 Drug Exposure During Pregnancy 4 0.6 0.6 no signal