OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Tiotropium Bromide And Olodaterol

194 flagged reaction(s) · 6,238 total co-reports · max PRR 16.3
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 Chronic Obstructive Pulmonary Disease 201 16.3 16.9 signal
2 Emphysema 26 10.8 10.9 signal
3 Productive Cough 99 8.8 9.0 signal
4 Respiratory Tract Congestion 32 8.5 8.5 signal
5 Acute Respiratory Failure 37 8.1 8.2 signal
6 Dyspnoea Exertional 72 8.1 8.2 signal
7 Candida Infection 30 7.6 7.6 signal
8 Dry Throat 18 7.5 7.5 signal
9 Choking 34 7.4 7.4 signal
10 Oral Discomfort 23 7.0 7.0 signal
11 Oxygen Saturation Decreased 91 6.9 7.0 signal
12 Dyspnoea 910 6.8 8.1 signal
13 Pulmonary Congestion 21 6.7 6.7 signal
14 Seasonal Allergy 22 6.6 6.6 signal
15 Dysphonia 88 6.3 6.4 signal
16 Aphonia 21 6.3 6.4 signal
17 Throat Irritation 65 6.1 6.2 signal
18 Cough 405 6.1 6.5 signal
19 Hospice Care 14 6.0 6.0 signal
20 Laryngitis 15 5.8 5.8 signal
21 Secretion Discharge 17 5.8 5.8 signal
22 Pulmonary Mass 20 5.7 5.7 signal
23 Device Delivery System Issue 35 5.6 5.7 signal
24 Extra Dose Administered 51 5.4 5.4 signal
25 Product Quality Issue 170 5.3 5.5 signal
26 Lung Neoplasm Malignant 50 5.1 5.1 signal
27 Retching 25 4.9 5.0 signal
28 Macular Degeneration 14 4.9 5.0 signal
29 Wheezing 68 4.8 4.9 signal
30 Heart Rate Irregular 26 4.8 4.8 signal
31 Pneumothorax 17 4.5 4.5 signal
32 Infusion Site Pain 13 4.3 4.3 signal
33 Product Packaging Quantity Issue 11 4.2 4.2 signal
34 Respiratory Tract Infection 26 4.2 4.2 signal
35 Device Malfunction 66 4.1 4.2 signal
36 Oropharyngeal Pain 90 4.1 4.1 signal
37 Sputum Discoloured 9 4.0 4.0 signal
38 Bronchitis 70 4.0 4.0 signal
39 Dizziness Postural 9 3.9 3.9 signal
40 Rhinorrhoea 60 3.9 4.0 signal
41 Sinus Disorder 18 3.8 3.8 signal
42 Musculoskeletal Chest Pain 14 3.8 3.8 signal
43 Lung Disorder 43 3.7 3.7 signal
44 Insurance Issue 13 3.7 3.7 signal
45 Product Packaging Issue 8 3.6 3.6 signal
46 Hypoacusis 37 3.6 3.6 signal
47 Chest Discomfort 86 3.5 3.6 signal
48 Dry Mouth 68 3.5 3.6 signal
49 Bronchospasm 12 3.5 3.5 signal
50 Nasal Congestion 49 3.5 3.5 signal
51 Ocular Discomfort 9 3.5 3.5 signal
52 Product Dispensing Error 17 3.3 3.3 signal
53 Intentional Dose Omission 21 3.2 3.2 signal
54 Urinary Retention 25 3.2 3.2 signal
55 Back Disorder 12 3.1 3.1 signal
56 Feeling Jittery 14 3.1 3.1 signal
57 Pulmonary Hypertension 15 3.0 3.0 signal
58 Ear Infection 19 3.0 3.0 signal
59 Oral Pain 16 3.0 3.0 signal
60 Dysuria 26 3.0 3.0 signal
61 Upper Respiratory Tract Infection 32 2.9 2.9 signal
62 Rib Fracture 14 2.9 2.9 signal
63 Pulmonary Fibrosis 13 2.9 2.9 signal
64 Device Issue 58 2.8 2.8 signal
65 Device Failure 10 2.8 2.8 signal
66 Hip Fracture 21 2.8 2.8 signal
67 Taste Disorder 13 2.7 2.7 signal
68 Skin Laceration 7 2.7 2.7 signal
69 Haemoptysis 18 2.7 2.7 signal
70 Pneumonia 208 2.7 2.8 signal
71 Urinary Incontinence 19 2.7 2.7 signal
72 Cataract 38 2.7 2.7 signal
73 Nervousness 33 2.6 2.7 signal
74 Impaired Quality Of Life 9 2.6 2.6 signal
75 Eye Infection 7 2.6 2.6 signal
76 Post Procedural Complication 12 2.6 2.6 signal
77 Neoplasm 7 2.6 2.6 signal
78 Feeding Disorder 12 2.5 2.5 signal
79 Pollakiuria 25 2.5 2.5 signal
80 Respiratory Disorder 18 2.5 2.5 signal
81 Hypoaesthesia Oral 9 2.5 2.5 signal
82 Sinus Congestion 8 2.5 2.5 signal
83 Tooth Abscess 6 2.5 2.5 no signal
84 Musculoskeletal Discomfort 10 2.4 2.4 signal
85 Foot Fracture 11 2.4 2.4 signal
86 Illness 58 2.4 2.4 signal
87 Heart Rate Increased 57 2.4 2.4 signal
88 Atrial Fibrillation 56 2.4 2.4 signal
89 Hereditary Angioedema 6 2.4 2.4 no signal
90 Glaucoma 11 2.4 2.4 signal
91 Intentional Product Use Issue 50 2.4 2.4 signal
92 Sinusitis 58 2.4 2.4 signal
93 Influenza 63 2.4 2.4 signal
94 Decreased Activity 6 2.4 2.4 no signal
95 Asthma 62 2.3 2.3 signal
96 Fluid Retention 28 2.3 2.3 signal
97 Upper Limb Fracture 11 2.3 2.3 signal
98 Brain Fog 8 2.3 2.3 signal
99 Obstructive Airways Disorder 6 2.3 2.3 no signal
100 Nephropathy 5 2.2 2.2 no signal
101 Cardiac Failure Congestive 43 2.2 2.2 signal
102 Pharyngeal Swelling 5 2.2 2.2 no signal
103 Epistaxis 39 2.2 2.2 signal
104 Hernia 10 2.2 2.2 signal
105 Drug Effect Incomplete 19 2.2 2.2 signal
106 Peripheral Swelling 79 2.2 2.2 signal
107 Pulmonary Oedema 23 2.2 2.2 signal
108 Back Pain 118 2.1 2.2 signal
109 Covid-19 Pneumonia 6 2.1 2.1 no signal
110 Bladder Disorder 5 2.1 2.1 no signal
111 Product Physical Issue 10 2.1 2.1 signal
112 Covid-19 88 2.1 2.1 signal
113 Sleep Disorder Due To A General Medical Condition 8 2.1 2.1 no signal
114 Initial Insomnia 5 2.1 2.1 no signal
115 Eye Discharge 5 2.1 2.1 no signal
116 Ear Discomfort 5 2.1 2.1 no signal
117 Eye Disorder 16 2.1 2.1 signal
118 Poor Venous Access 5 2.0 2.0 no signal
119 Scratch 5 2.0 2.0 no signal
120 Product Odour Abnormal 5 2.0 2.0 no signal
121 Throat Tightness 13 2.0 2.0 signal
122 Product Complaint 12 2.0 2.0 signal
123 Pulmonary Arterial Hypertension 7 2.0 2.0 no signal
124 Renal Pain 5 2.0 2.0 no signal
125 Pulmonary Thrombosis 5 1.9 1.9 no signal
126 Immune System Disorder 6 1.9 1.9 no signal
127 Eye Pain 25 1.9 1.9 no signal
128 Limb Discomfort 14 1.9 1.9 no signal
129 Medication Error 25 1.9 1.9 no signal
130 Therapy Interrupted 31 1.9 1.9 no signal
131 Swollen Tongue 14 1.9 1.9 no signal
132 Sneezing 10 1.9 1.9 no signal
133 Product Taste Abnormal 6 1.9 1.9 no signal
134 Therapeutic Response Unexpected 20 1.9 1.9 no signal
135 Speech Disorder 23 1.8 1.8 no signal
136 Product Dose Omission Issue 123 1.8 1.8 no signal
137 Vision Blurred 59 1.8 1.8 no signal
138 Blood Test Abnormal 6 1.8 1.8 no signal
139 Muscle Spasms 77 1.8 1.8 no signal
140 Wrist Fracture 5 1.8 1.8 no signal
141 Anhedonia 11 1.7 1.7 no signal
142 Localised Infection 10 1.7 1.7 no signal
143 Dry Eye 20 1.7 1.7 no signal
144 Oral Herpes 8 1.7 1.7 no signal
145 Decreased Immune Responsiveness 4 1.7 1.7 no signal
146 Cardiac Disorder 38 1.7 1.7 no signal
147 Glossodynia 9 1.7 1.7 no signal
148 Spinal Fracture 8 1.7 1.7 no signal
149 Product Administration Error 8 1.7 1.7 no signal
150 Lip Swelling 13 1.6 1.6 no signal
151 Neoplasm Malignant 26 1.6 1.6 no signal
152 Unevaluable Event 29 1.6 1.6 no signal
153 Hallucination, Visual 8 1.6 1.6 no signal
154 Complication Associated With Device 5 1.6 1.6 no signal
155 Therapy Cessation 19 1.6 1.6 no signal
156 Device Defective 6 1.6 1.6 no signal
157 Dementia 10 1.5 1.5 no signal
158 Intentional Product Misuse 30 1.5 1.5 no signal
159 Product Prescribing Error 8 1.4 1.4 no signal
160 Product Dose Omission In Error 9 1.4 1.4 no signal
161 Spinal Operation 4 1.4 1.4 no signal
162 Blood Count Abnormal 5 1.4 1.4 no signal
163 Device Use Error 11 1.4 1.4 no signal
164 Lymphoma 5 1.4 1.4 no signal
165 Device Mechanical Issue 4 1.3 1.3 no signal
166 Metastases To Bone 5 1.3 1.3 no signal
167 Hunger 4 1.2 1.3 no signal
168 Procedural Pain 8 1.2 1.2 no signal
169 Breast Cancer Metastatic 3 1.2 1.2 no signal
170 Anosmia 4 1.2 1.2 no signal
171 Dry Skin 35 1.1 1.1 no signal
172 Drug Dispensing Error 4 1.1 1.1 no signal
173 Drug Dose Omission By Device 18 1.0 1.0 no signal
174 Device Use Issue 4 1.0 1.0 no signal
175 Blood Glucose Decreased 11 1.0 1.0 no signal
176 Myocardial Infarction 40 1.0 1.0 no signal
177 Therapeutic Response Shortened 7 0.9 0.9 no signal
178 Wrong Technique In Device Usage Process 10 0.9 0.9 no signal
179 Prostatic Specific Antigen Increased 3 0.9 0.9 no signal
180 Device Leakage 9 0.9 0.9 no signal
181 Intentional Overdose 13 0.9 0.9 no signal
182 Incorrect Dose Administered By Device 5 0.8 0.8 no signal
183 Accidental Exposure To Product 18 0.8 0.8 no signal
184 Exposure Via Skin Contact 4 0.7 0.7 no signal
185 Application Site Pruritus 4 0.7 0.7 no signal
186 Gastric Cancer 4 0.7 0.7 no signal
187 Breast Cancer Female 4 0.6 0.6 no signal
188 Product Preparation Error 3 0.6 0.6 no signal
189 Injection Site Rash 4 0.6 0.6 no signal
190 Gynaecomastia 4 0.5 0.5 no signal
191 Device Breakage 5 0.5 0.5 no signal
192 Device Difficult To Use 8 0.5 0.5 no signal
193 Application Site Erythema 3 0.5 0.5 no signal
194 Bladder Cancer 5 0.4 0.4 no signal