OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Ketotifen Fumarate

156 flagged reaction(s) · 9,426 total co-reports · max PRR 101.3
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 2,496 101.3 164.0 signal
2 Eye Irritation 637 37.3 41.3 signal
3 Eye Pruritus 214 21.1 21.8 signal
4 Eye Pain 276 16.2 16.9 signal
5 Ocular Hyperaemia 226 15.7 16.2 signal
6 Eye Discharge 44 14.0 14.1 signal
7 Eye Inflammation 35 12.0 12.1 signal
8 Eyelid Oedema 40 11.1 11.1 signal
9 Tenderness 34 10.6 10.6 signal
10 Photophobia 52 9.0 9.1 signal
11 Lacrimation Increased 83 9.0 9.1 signal
12 Skin Reaction 39 9.0 9.0 signal
13 Ocular Discomfort 30 8.9 9.0 signal
14 Eye Swelling 101 8.8 9.0 signal
15 Hereditary Angioedema 25 7.7 7.7 signal
16 Foot Deformity 26 7.6 7.6 signal
17 Dry Eye 111 7.4 7.5 signal
18 Scratch 23 7.2 7.2 signal
19 Ankle Fracture 29 6.1 6.1 signal
20 Seasonal Allergy 26 6.0 6.0 signal
21 Paraesthesia Oral 26 5.9 5.9 signal
22 Ear Pain 35 5.8 5.9 signal
23 Sneezing 39 5.6 5.7 signal
24 Synovitis 28 5.0 5.0 signal
25 Paralysis 22 5.0 5.0 signal
26 Foot Fracture 29 4.9 5.0 signal
27 Osteoarthritis 64 4.9 4.9 signal
28 Muscle Tightness 24 4.8 4.8 signal
29 Pharyngeal Swelling 14 4.7 4.7 signal
30 Thinking Abnormal 27 4.7 4.7 signal
31 Oral Pain 32 4.6 4.6 signal
32 Eye Disorder 42 4.1 4.2 signal
33 Expired Product Administered 41 4.0 4.0 signal
34 Anaphylactic Reaction 66 3.9 3.9 signal
35 Temperature Intolerance 12 3.8 3.8 signal
36 Angioedema 51 3.7 3.8 signal
37 Conjunctivitis 21 3.7 3.7 signal
38 Obesity 18 3.6 3.7 signal
39 Eye Infection 12 3.5 3.5 signal
40 Vision Blurred 146 3.5 3.5 signal
41 Clostridium Difficile Infection 22 3.3 3.3 signal
42 Wheezing 59 3.2 3.2 signal
43 Skin Disorder 33 3.2 3.2 signal
44 Generalised Oedema 12 3.2 3.2 signal
45 Dermatitis Contact 11 3.1 3.1 signal
46 Middle Insomnia 18 3.1 3.1 signal
47 Hypersensitivity 174 3.0 3.1 signal
48 Intraocular Pressure Increased 12 3.0 3.0 signal
49 Blister 50 2.9 2.9 signal
50 Wound 23 2.7 2.7 signal
51 Rhinorrhoea 53 2.7 2.7 signal
52 Psoriatic Arthropathy 33 2.7 2.7 signal
53 Urticaria 134 2.6 2.6 signal
54 Injection Site Extravasation 10 2.6 2.6 signal
55 Viral Infection 26 2.5 2.5 signal
56 Gastroenteritis Viral 14 2.5 2.5 signal
57 Dysphagia 72 2.5 2.5 signal
58 Product Packaging Issue 7 2.4 2.4 signal
59 Eye Haemorrhage 10 2.4 2.4 signal
60 Intestinal Obstruction 28 2.4 2.4 signal
61 Asthma 83 2.4 2.4 signal
62 Vitreous Floaters 7 2.3 2.3 signal
63 Neck Pain 40 2.3 2.3 signal
64 Burning Sensation 50 2.3 2.3 signal
65 Body Temperature Decreased 7 2.3 2.3 no signal
66 Drug Ineffective 915 2.2 2.5 signal
67 Visual Impairment 85 2.2 2.2 signal
68 Eyelid Ptosis 7 2.2 2.2 no signal
69 Oedema 37 2.2 2.2 signal
70 Adverse Reaction 9 2.2 2.2 signal
71 Poor Venous Access 7 2.2 2.2 no signal
72 Glaucoma 13 2.2 2.2 signal
73 Speech Disorder 35 2.2 2.2 signal
74 Hypoaesthesia Oral 10 2.1 2.1 signal
75 Drug Hypersensitivity 126 2.1 2.1 signal
76 Product Use Complaint 10 2.1 2.1 signal
77 Interstitial Lung Disease 31 2.1 2.1 signal
78 Nephropathy 6 2.1 2.1 no signal
79 Dysphonia 37 2.0 2.1 signal
80 Mydriasis 8 2.0 2.0 no signal
81 Ligament Sprain 6 2.0 2.0 no signal
82 Osteoporosis 24 1.9 1.9 no signal
83 Pruritus 218 1.9 1.9 no signal
84 Blood Pressure Increased 87 1.8 1.8 no signal
85 Rash Pruritic 30 1.8 1.8 no signal
86 Inappropriate Schedule Of Product Administration 98 1.8 1.8 no signal
87 Product Packaging Quantity Issue 6 1.8 1.8 no signal
88 Anaphylactic Shock 14 1.8 1.8 no signal
89 Bone Pain 32 1.8 1.8 no signal
90 Tuberculosis 7 1.8 1.8 no signal
91 Swollen Tongue 17 1.8 1.8 no signal
92 Joint Swelling 65 1.7 1.8 no signal
93 Chest Discomfort 55 1.7 1.7 no signal
94 Rash Erythematous 25 1.7 1.7 no signal
95 Face Oedema 9 1.7 1.7 no signal
96 Therapy Partial Responder 8 1.7 1.7 no signal
97 Contusion 51 1.7 1.7 no signal
98 Contraindicated Product Administered 16 1.7 1.7 no signal
99 Musculoskeletal Stiffness 45 1.7 1.7 no signal
100 Arthritis 39 1.6 1.6 no signal
101 Sleep Disorder Due To A General Medical Condition 8 1.6 1.6 no signal
102 Initial Insomnia 5 1.6 1.6 no signal
103 Product Quality Issue 66 1.6 1.6 no signal
104 Tooth Abscess 5 1.6 1.6 no signal
105 Erythema 99 1.6 1.6 no signal
106 Illness 48 1.5 1.5 no signal
107 Mobility Decreased 34 1.5 1.5 no signal
108 Infusion Site Pain 6 1.5 1.5 no signal
109 Abdominal Discomfort 78 1.5 1.5 no signal
110 Blood Pressure Systolic Increased 9 1.5 1.5 no signal
111 Dry Skin 60 1.5 1.5 no signal
112 Aphonia 6 1.4 1.4 no signal
113 Madarosis 5 1.4 1.4 no signal
114 Hallucination 32 1.4 1.4 no signal
115 Hepatocellular Injury 6 1.4 1.4 no signal
116 Product Dose Omission In Error 11 1.3 1.3 no signal
117 Insurance Issue 6 1.3 1.3 no signal
118 Product Availability Issue 9 1.3 1.3 no signal
119 Hair Colour Changes 5 1.3 1.3 no signal
120 Lip Swelling 13 1.3 1.3 no signal
121 Product Odour Abnormal 4 1.2 1.2 no signal
122 Bone Disorder 7 1.2 1.2 no signal
123 Body Height Decreased 4 1.2 1.2 no signal
124 Pharyngitis Streptococcal 4 1.2 1.2 no signal
125 Injection Site Pruritus 24 1.2 1.2 no signal
126 Therapeutic Product Effect Decreased 16 1.2 1.2 no signal
127 Oral Discomfort 5 1.2 1.2 no signal
128 Visual Acuity Reduced 12 1.2 1.2 no signal
129 Throat Irritation 16 1.2 1.2 no signal
130 Rash Papular 8 1.2 1.2 no signal
131 Rheumatoid Arthritis 37 1.1 1.1 no signal
132 Product Complaint 8 1.0 1.0 no signal
133 Eczema 16 1.0 1.0 no signal
134 Product Dose Omission Issue 90 1.0 1.0 no signal
135 Exposure Via Skin Contact 7 1.0 1.0 no signal
136 Poor Quality Product Administered 3 0.9 0.9 no signal
137 Extra Dose Administered 11 0.9 0.9 no signal
138 Drug Effect Decreased 14 0.8 0.8 no signal
139 Therapeutic Response Shortened 8 0.8 0.8 no signal
140 Needle Issue 7 0.8 0.8 no signal
141 Dermatitis Atopic 12 0.8 0.8 no signal
142 Skin Irritation 11 0.8 0.8 no signal
143 Blood Glucose Increased 44 0.8 0.7 no signal
144 Product Dispensing Error 5 0.7 0.7 no signal
145 Anorexia 3 0.7 0.7 no signal
146 Product Taste Abnormal 3 0.7 0.7 no signal
147 Hair Texture Abnormal 3 0.7 0.7 no signal
148 Injection Site Mass 8 0.7 0.7 no signal
149 Injection Site Rash 6 0.6 0.6 no signal
150 Injection Site Urticaria 4 0.5 0.5 no signal
151 Drug Effect Incomplete 6 0.5 0.5 no signal
152 Accidental Exposure To Product 16 0.5 0.5 no signal
153 Wrong Technique In Drug Usage Process 5 0.4 0.4 no signal
154 Injection Site Swelling 9 0.4 0.4 no signal
155 Pharmaceutical Product Complaint 3 0.4 0.4 no signal
156 Incorrect Route Of Drug Administration 4 0.4 0.4 no signal