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Drug

Formoterol Fumarate

312 flagged reaction(s) · 21,812 total co-reports · max PRR 242.3
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 Obstructive Airways Disorder 415 242.3 276.5 signal
2 Full Blood Count Abnormal 316 193.8 214.0 signal
3 Sputum Discoloured 189 128.0 135.6 signal
4 Sleep Disorder Due To A General Medical Condition 252 99.3 107.3 signal
5 Blood Test Abnormal 197 89.3 94.8 signal
6 Emphysema 136 85.4 89.0 signal
7 Vasculitis 124 67.4 70.0 signal
8 Sleep Apnoea Syndrome 201 66.6 70.8 signal
9 Asthma 1,074 60.7 88.9 signal
10 Wheezing 563 60.3 72.3 signal
11 Arteriosclerosis 88 59.1 60.7 signal
12 Pulmonary Mass 135 57.5 59.8 signal
13 Pulmonary Fibrosis 152 50.3 52.6 signal
14 Nodule 94 45.5 46.8 signal
15 Haemoptysis 191 43.1 45.7 signal
16 Hypothyroidism 212 42.0 44.8 signal
17 Carpal Tunnel Syndrome 91 40.9 42.0 signal
18 Therapeutic Product Effect Incomplete 440 39.3 45.1 signal
19 Aspiration 65 37.9 38.6 signal
20 Productive Cough 258 34.4 37.2 signal
21 Iron Deficiency Anaemia 50 34.3 34.8 signal
22 Loss Of Personal Independence In Daily Activities 245 32.5 35.0 signal
23 Gastrooesophageal Reflux Disease 383 30.1 33.9 signal
24 Hypoxia 160 28.7 30.1 signal
25 Nephropathy 41 27.5 27.8 signal
26 Hiatus Hernia 53 25.7 26.1 signal
27 Fibromyalgia 95 24.6 25.3 signal
28 Lower Respiratory Tract Infection 166 23.1 24.2 signal
29 Skin Laceration 38 22.1 22.4 signal
30 Blood Iron Decreased 37 19.7 20.0 signal
31 Sinus Disorder 62 19.7 20.0 signal
32 Candida Infection 52 19.6 19.9 signal
33 Blood Pressure Systolic Increased 61 19.6 19.9 signal
34 Body Temperature Decreased 30 19.0 19.2 signal
35 Abscess 48 18.9 19.2 signal
36 Respiratory Disorder 87 18.2 18.7 signal
37 Osteopenia 44 18.1 18.4 signal
38 Hypoaesthesia Oral 41 17.1 17.3 signal
39 Liver Function Test Increased 58 17.1 17.4 signal
40 Pulmonary Congestion 36 17.1 17.3 signal
41 Transaminases Increased 60 17.0 17.3 signal
42 Chronic Obstructive Pulmonary Disease 140 16.9 17.6 signal
43 Skin Lesion 73 16.9 17.2 signal
44 Upper Respiratory Tract Infection 123 16.8 17.4 signal
45 Respiratory Tract Infection 69 16.7 17.0 signal
46 Dyspnoea Exertional 99 16.6 17.1 signal
47 Restless Legs Syndrome 48 16.6 16.8 signal
48 Hypokinesia 38 16.4 16.6 signal
49 Eosinophilia 45 16.2 16.4 signal
50 Lung Disorder 126 16.2 16.8 signal
51 Type 2 Diabetes Mellitus 86 16.0 16.4 signal
52 Ear Pain 49 15.8 16.1 signal
53 Limb Injury 66 15.3 15.6 signal
54 Coronary Artery Disease 73 15.0 15.4 signal
55 Joint Injury 51 15.0 15.2 signal
56 Blood Count Abnormal 36 14.7 14.9 signal
57 Eczema 116 14.5 15.0 signal
58 Cough 628 14.1 17.1 signal
59 Osteoporosis 90 13.7 14.1 signal
60 Chest Discomfort 210 12.9 13.7 signal
61 Blood Urine Present 39 12.9 13.0 signal
62 Disability 40 12.7 12.8 signal
63 Nasal Congestion 118 12.7 13.1 signal
64 Oral Candidiasis 26 12.6 12.6 signal
65 Sinus Congestion 27 12.5 12.6 signal
66 Procedural Pain 55 12.5 12.7 signal
67 Eyelid Ptosis 20 12.4 12.4 signal
68 Dyspnoea 1,106 12.3 17.9 signal
69 Body Temperature Increased 40 12.3 12.4 signal
70 Renal Disorder 91 12.2 12.6 signal
71 Burning Sensation 135 12.1 12.6 signal
72 Disease Recurrence 90 11.9 12.2 signal
73 Bronchospasm 27 11.9 11.9 signal
74 Respiratory Tract Congestion 30 11.8 11.9 signal
75 Oedema 100 11.6 11.9 signal
76 Pulmonary Embolism 174 11.5 12.0 signal
77 Hypercholesterolaemia 17 11.2 11.2 signal
78 Bronchitis 131 11.1 11.5 signal
79 Middle Insomnia 30 10.1 10.2 signal
80 Hypertensive Crisis 18 10.1 10.2 signal
81 Throat Irritation 72 10.1 10.3 signal
82 Fungal Infection 53 10.0 10.1 signal
83 Wound 44 9.9 10.1 signal
84 Feeling Cold 44 9.9 10.0 signal
85 Oedema Peripheral 189 9.7 10.2 signal
86 Thrombosis 122 9.5 9.8 signal
87 Rhinorrhoea 95 9.3 9.5 signal
88 Cardiac Disorder 138 9.2 9.6 signal
89 Oesophagitis 16 9.2 9.2 signal
90 Therapy Partial Responder 22 9.2 9.2 signal
91 Secretion Discharge 18 9.1 9.2 signal
92 Hypertension 304 9.0 9.8 signal
93 Dysuria 52 8.9 9.0 signal
94 Sinusitis 145 8.9 9.2 signal
95 Brain Injury 14 8.8 8.8 signal
96 Oropharyngeal Pain 128 8.7 9.0 signal
97 Hypoacusis 59 8.6 8.8 signal
98 Seasonal Allergy 19 8.5 8.5 signal
99 Wrist Fracture 16 8.4 8.4 signal
100 Pneumonia 430 8.4 9.4 signal
101 Blood Pressure Fluctuation 32 8.3 8.4 signal
102 Paralysis 19 8.3 8.3 signal
103 Acute Respiratory Failure 25 8.2 8.3 signal
104 Bacterial Infection 24 8.1 8.2 signal
105 Eye Haemorrhage 17 8.0 8.0 signal
106 Movement Disorder 41 8.0 8.1 signal
107 Urinary Retention 42 7.9 8.0 signal
108 Panic Attack 46 7.9 8.0 signal
109 Choking 24 7.8 7.8 signal
110 Aphonia 17 7.7 7.7 signal
111 Ligament Sprain 12 7.6 7.7 signal
112 Osteoarthritis 51 7.5 7.6 signal
113 Blood Creatinine Increased 76 7.3 7.4 signal
114 Conjunctivitis 21 7.2 7.2 signal
115 Lung Infection 18 7.2 7.2 signal
116 Glaucoma 22 7.2 7.2 signal
117 Haematuria 39 7.1 7.2 signal
118 Pollakiuria 47 7.1 7.2 signal
119 Sneezing 25 7.0 7.1 signal
120 Gout 20 7.0 7.0 signal
121 Transient Ischaemic Attack 37 6.9 6.9 signal
122 Pleural Effusion 66 6.8 6.9 signal
123 Oxygen Saturation Decreased 60 6.7 6.9 signal
124 Nephrolithiasis 49 6.7 6.8 signal
125 Influenza 119 6.7 6.9 signal
126 Sinus Tachycardia 15 6.6 6.7 signal
127 Immunodeficiency 15 6.4 6.4 signal
128 Sleep Disorder 71 6.4 6.5 signal
129 Cellulitis 51 6.3 6.4 signal
130 Dysarthria 38 6.3 6.4 signal
131 Hyperglycaemia 36 6.2 6.3 signal
132 Acute Myocardial Infarction 29 6.1 6.2 signal
133 Heart Rate Increased 95 6.0 6.2 signal
134 Cardiac Failure 76 5.9 6.1 signal
135 Dysphonia 54 5.8 5.9 signal
136 Diabetes Mellitus 69 5.7 5.8 signal
137 Salivary Hypersecretion 9 5.7 5.7 signal
138 Tooth Abscess 9 5.5 5.5 signal
139 Pallor 24 5.5 5.6 signal
140 Cardiomyopathy 13 5.5 5.5 signal
141 Blood Pressure Increased 134 5.5 5.7 signal
142 Blister 49 5.5 5.6 signal
143 Syncope 86 5.4 5.5 signal
144 Accident 10 5.3 5.3 signal
145 Basal Cell Carcinoma 13 5.2 5.2 signal
146 Musculoskeletal Stiffness 72 5.2 5.2 signal
147 Myocardial Infarction 144 5.1 5.3 signal
148 Deep Vein Thrombosis 53 5.1 5.2 signal
149 Hospitalisation 123 5.1 5.2 signal
150 Lacrimation Increased 24 5.0 5.1 signal
151 Rebound Effect 9 5.0 5.0 signal
152 Ear Infection 21 5.0 5.0 signal
153 Initial Insomnia 8 4.9 4.9 signal
154 Urinary Incontinence 23 4.9 4.9 signal
155 Injection Site Discomfort 8 4.9 4.9 signal
156 Clostridium Difficile Colitis 8 4.7 4.7 signal
157 Intervertebral Disc Degeneration 7 4.7 4.7 signal
158 Obesity 12 4.7 4.7 signal
159 Dysstasia 22 4.7 4.7 signal
160 Quality Of Life Decreased 10 4.7 4.7 signal
161 Multi-organ Failure 13 4.7 4.7 signal
162 Tachypnoea 10 4.6 4.6 signal
163 Spinal Disorder 7 4.6 4.6 signal
164 Illness 74 4.6 4.7 signal
165 Tooth Fracture 8 4.6 4.6 signal
166 Road Traffic Accident 30 4.5 4.5 signal
167 Pulmonary Oedema 32 4.5 4.5 signal
168 Anxiety 203 4.5 4.7 signal
169 Condition Aggravated 212 4.4 4.6 signal
170 Lung Neoplasm Malignant 29 4.4 4.4 signal
171 Pain In Extremity 206 4.4 4.6 signal
172 Anaphylactic Reaction 38 4.3 4.4 signal
173 Chest Pain 128 4.3 4.5 signal
174 Inappropriate Antidiuretic Hormone Secretion 7 4.3 4.3 signal
175 Weight Increased 153 4.3 4.5 signal
176 Heart Rate Decreased 24 4.3 4.3 signal
177 Skin Exfoliation 56 4.2 4.3 signal
178 Electrocardiogram Qt Prolonged 24 4.2 4.2 signal
179 Influenza Like Illness 55 4.2 4.2 signal
180 Renal Pain 7 4.2 4.2 signal
181 Schizophrenia 8 4.1 4.1 signal
182 Respiratory Failure 48 4.1 4.2 signal
183 Limb Discomfort 20 4.1 4.1 signal
184 Depression 147 4.0 4.2 signal
185 Tooth Extraction 8 4.0 4.0 signal
186 Nasopharyngitis 118 4.0 4.1 signal
187 Drug Hypersensitivity 124 4.0 4.1 signal
188 Balance Disorder 55 4.0 4.0 signal
189 Fracture 12 4.0 4.0 signal
190 Hepatotoxicity 14 4.0 4.0 signal
191 General Physical Health Deterioration 72 3.9 4.0 signal
192 Paraesthesia 98 3.9 4.0 signal
193 Micturition Urgency 7 3.9 3.9 signal
194 Chills 72 3.8 3.9 signal
195 Platelet Count Increased 8 3.8 3.8 signal
196 Adverse Event 56 3.8 3.9 signal
197 Pyrexia 210 3.8 4.0 signal
198 Mobility Decreased 43 3.8 3.8 signal
199 Back Pain 139 3.8 3.9 signal
200 Adrenal Insufficiency 7 3.7 3.7 signal
201 Contusion 56 3.7 3.7 signal
202 Myalgia 99 3.7 3.7 signal
203 Weight Decreased 162 3.6 3.8 signal
204 Paranoia 10 3.6 3.6 signal
205 Abdominal Distension 60 3.6 3.7 signal
206 Lethargy 33 3.6 3.6 signal
207 Gait Disturbance 110 3.6 3.7 signal
208 Blood Pressure Decreased 38 3.6 3.6 signal
209 Heart Rate Irregular 13 3.6 3.6 signal
210 Mass 8 3.6 3.6 signal
211 Joint Dislocation 6 3.6 3.6 signal
212 Migraine 54 3.6 3.6 signal
213 Oral Herpes 11 3.5 3.6 signal
214 Angina Pectoris 16 3.5 3.5 signal
215 Gastroenteritis 8 3.4 3.5 signal
216 Tremor 91 3.4 3.5 signal
217 Retinal Detachment 5 3.4 3.4 signal
218 Respiratory Distress 15 3.4 3.4 signal
219 Headache 338 3.4 3.7 signal
220 Hypersensitivity 100 3.4 3.5 signal
221 Skin Infection 6 3.4 3.4 signal
222 Hepatic Encephalopathy 5 3.4 3.4 signal
223 Urinary Tract Infection 90 3.3 3.4 signal
224 Cataract 31 3.3 3.3 signal
225 Tinnitus 24 3.3 3.3 signal
226 Cholelithiasis 17 3.3 3.3 signal
227 Cardiac Failure Congestive 42 3.2 3.3 signal
228 Hypoaesthesia 77 3.2 3.3 signal
229 Diverticulitis 14 3.2 3.2 signal
230 Polyneuropathy 6 3.2 3.2 signal
231 Fall 167 3.2 3.3 signal
232 Cystitis 16 3.1 3.2 signal
233 Diplopia 13 3.1 3.1 signal
234 Hypotonia 5 3.1 3.1 signal
235 Gastroenteritis Viral 9 3.1 3.1 signal
236 Back Disorder 8 3.1 3.1 signal
237 Hypercalcaemia 6 3.1 3.1 signal
238 Throat Tightness 13 3.0 3.0 signal
239 Pneumonitis 13 3.0 3.0 signal
240 Peripheral Swelling 73 3.0 3.0 signal
241 Mouth Ulceration 10 3.0 3.0 signal
242 Malaise 208 3.0 3.1 signal
243 Retching 10 2.9 3.0 signal
244 Infusion Site Pain 6 2.9 3.0 signal
245 Drug Dependence 76 2.9 3.0 signal
246 Body Height Decreased 5 2.9 2.9 signal
247 Discomfort 28 2.9 2.9 signal
248 Ocular Discomfort 5 2.9 2.9 signal
249 Palpitations 53 2.8 2.9 signal
250 Foot Deformity 5 2.8 2.8 signal
251 Rash Erythematous 21 2.8 2.8 signal
252 Urticaria 74 2.8 2.8 signal
253 Inappropriate Schedule Of Product Administration 78 2.8 2.8 signal
254 Psychotic Disorder 13 2.8 2.8 signal
255 Aggression 22 2.8 2.8 signal
256 Gastrointestinal Carcinoma 4 2.7 2.7 no signal
257 Coronary Artery Occlusion 6 2.7 2.7 signal
258 Oral Discomfort 6 2.7 2.7 signal
259 Leukaemia 4 2.7 2.7 no signal
260 Feeling Hot 26 2.7 2.7 signal
261 Thyroid Cancer 5 2.6 2.6 no signal
262 Wrong Technique In Drug Usage Process 15 2.6 2.6 signal
263 Lactic Acidosis 13 2.5 2.5 signal
264 Muscle Spasticity 5 2.5 2.5 no signal
265 Dermatitis Allergic 5 2.5 2.5 no signal
266 Dry Throat 4 2.5 2.5 no signal
267 Covid-19 69 2.4 2.5 signal
268 Tuberculosis 5 2.4 2.4 no signal
269 Tendonitis 6 2.4 2.4 no signal
270 Swollen Tongue 12 2.4 2.4 signal
271 Product Dose Omission Issue 104 2.3 2.3 signal
272 Respiratory Arrest 10 2.3 2.3 signal
273 Adverse Drug Reaction 32 2.2 2.3 signal
274 Withdrawal Syndrome 15 2.2 2.2 signal
275 Neoplasm 4 2.2 2.2 no signal
276 Therapeutic Response Shortened 11 2.2 2.2 signal
277 Maternal Exposure During Pregnancy 30 2.1 2.1 signal
278 Haemorrhage 34 2.0 2.1 signal
279 Tendon Rupture 4 2.0 2.0 no signal
280 Femur Fracture 10 2.0 2.0 signal
281 Drug Exposure During Pregnancy 11 2.0 2.0 signal
282 Injection Site Swelling 24 2.0 2.0 no signal
283 Colitis Ulcerative 14 2.0 2.0 no signal
284 Injection Site Bruising 24 1.9 1.9 no signal
285 Angioedema 13 1.8 1.9 no signal
286 Hepatocellular Injury 4 1.8 1.8 no signal
287 Extrapyramidal Disorder 7 1.8 1.8 no signal
288 Anosmia 4 1.7 1.7 no signal
289 Eye Pruritus 9 1.7 1.7 no signal
290 Injection Site Pain 82 1.7 1.7 no signal
291 Blood Glucose Abnormal 5 1.7 1.7 no signal
292 Incorrect Dose Administered 60 1.7 1.7 no signal
293 Rheumatoid Arthritis 30 1.7 1.7 no signal
294 Internal Haemorrhage 3 1.6 1.6 no signal
295 Injection Site Pruritus 17 1.6 1.6 no signal
296 Device Malfunction 17 1.6 1.6 no signal
297 Metastases To Central Nervous System 3 1.5 1.5 no signal
298 Complication Associated With Device 3 1.4 1.4 no signal
299 Incorrect Route Of Drug Administration 8 1.4 1.4 no signal
300 Myelosuppression 7 1.3 1.3 no signal
301 Abortion Spontaneous 8 1.2 1.2 no signal
302 Premature Baby 6 1.2 1.2 no signal
303 Injection Site Erythema 23 1.2 1.2 no signal
304 Dystonia 3 1.0 1.0 no signal
305 Injection Site Warmth 3 0.9 0.9 no signal
306 Exposure Via Skin Contact 3 0.8 0.8 no signal
307 Gastric Cancer 3 0.7 0.7 no signal
308 Dependence 6 0.7 0.7 no signal
309 Completed Suicide 9 0.7 0.7 no signal
310 Device Dislocation 4 0.6 0.6 no signal
311 Wrong Technique In Device Usage Process 4 0.5 0.5 no signal
312 Bladder Cancer 3 0.3 0.3 no signal