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FORMOTEROL FUMARATE

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Formoterol Fumarate Adverse Events Reported to the FDA Over Time

How are Formoterol Fumarate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Formoterol Fumarate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Formoterol Fumarate is flagged as the suspect drug causing the adverse event.

Most Common Formoterol Fumarate Adverse Events Reported to the FDA

What are the most common Formoterol Fumarate adverse events reported to the FDA?

Dyspnoea
3119 (6.99%)
Drug Dose Omission
1660 (3.72%)
Asthma
1149 (2.57%)
Malaise
949 (2.13%)
Drug Ineffective
893 (2%)
Cough
883 (1.98%)
Chronic Obstructive Pulmonary Disea...
828 (1.86%)
Pneumonia
748 (1.68%)
Dysphonia
490 (1.1%)
Intentional Drug Misuse
458 (1.03%)
Wheezing
454 (1.02%)
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Off Label Use
445 (1%)
Incorrect Dose Administered
417 (.93%)
Headache
402 (.9%)
Chest Discomfort
376 (.84%)
Fatigue
370 (.83%)
Tremor
359 (.8%)
Death
357 (.8%)
Chest Pain
353 (.79%)
Dizziness
332 (.74%)
Bronchitis
319 (.71%)
Hypertension
300 (.67%)
Insomnia
298 (.67%)
Oropharyngeal Pain
294 (.66%)
Fall
268 (.6%)
Weight Increased
268 (.6%)
Nasopharyngitis
262 (.59%)
Throat Irritation
257 (.58%)
Nausea
249 (.56%)
Pain
245 (.55%)
Emphysema
213 (.48%)
Diabetes Mellitus
211 (.47%)
Oedema Peripheral
210 (.47%)
Nervousness
209 (.47%)
Gastrooesophageal Reflux Disease
208 (.47%)
Condition Aggravated
207 (.46%)
Muscle Spasms
205 (.46%)
Blood Pressure Increased
204 (.46%)
Feeling Abnormal
199 (.45%)
Palpitations
193 (.43%)
Back Pain
190 (.43%)
Dry Mouth
187 (.42%)
Anxiety
185 (.41%)
Cerebrovascular Accident
180 (.4%)
Asthenia
176 (.39%)
Myocardial Infarction
176 (.39%)
Tachycardia
176 (.39%)
Pyrexia
175 (.39%)
Vomiting
171 (.38%)
Cardiac Disorder
168 (.38%)
Lung Disorder
164 (.37%)
Heart Rate Increased
162 (.36%)
Lung Neoplasm Malignant
162 (.36%)
Cataract
161 (.36%)
Respiratory Disorder
158 (.35%)
Aphonia
155 (.35%)
Weight Decreased
142 (.32%)
Hypersensitivity
141 (.32%)
Increased Upper Airway Secretion
140 (.31%)
Adverse Event
138 (.31%)
Depression
134 (.3%)
Influenza
134 (.3%)
Sinusitis
130 (.29%)
Abdominal Pain Upper
129 (.29%)
Rash
129 (.29%)
Feeling Jittery
127 (.28%)
Pain In Extremity
126 (.28%)
Syncope
124 (.28%)
Dysgeusia
123 (.28%)
Vision Blurred
122 (.27%)
Memory Impairment
119 (.27%)
Diarrhoea
118 (.26%)
Pruritus
116 (.26%)
Circumstance Or Information Capable...
114 (.26%)
Candidiasis
112 (.25%)
Neoplasm Malignant
109 (.24%)
Gait Disturbance
107 (.24%)
Nasal Congestion
107 (.24%)
Drug Effect Decreased
106 (.24%)
Inappropriate Schedule Of Drug Admi...
106 (.24%)
Arthralgia
104 (.23%)
Hallucination
104 (.23%)
Oral Candidiasis
103 (.23%)
Somnolence
102 (.23%)
Bronchospasm
98 (.22%)
Device Malfunction
97 (.22%)
Dyspnoea Exertional
96 (.22%)
Hypoaesthesia
95 (.21%)
Visual Impairment
95 (.21%)
Respiratory Failure
94 (.21%)
Pulmonary Congestion
93 (.21%)
Wrong Technique In Drug Usage Proce...
93 (.21%)
Productive Cough
91 (.2%)
Cardiac Failure Congestive
90 (.2%)
Dyspepsia
90 (.2%)
Drug Exposure During Pregnancy
89 (.2%)
Laryngitis
89 (.2%)
Rhinorrhoea
88 (.2%)
Urticaria
84 (.19%)
Swelling Face
83 (.19%)
Loss Of Consciousness
82 (.18%)

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This graph shows the top adverse events submitted to the FDA for Formoterol Fumarate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Formoterol Fumarate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Formoterol Fumarate

What are the most common Formoterol Fumarate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Formoterol Fumarate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Formoterol Fumarate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Formoterol Fumarate According to Those Reporting Adverse Events

Why are people taking Formoterol Fumarate, according to those reporting adverse events to the FDA?

Asthma
4534
Chronic Obstructive Pulmonary Disea...
3102
Product Used For Unknown Indication
1015
Drug Use For Unknown Indication
804
Emphysema
493
Dyspnoea
368
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Bronchitis
319
Cough
133
Lung Disorder
99
Bronchitis Chronic
93
Respiratory Disorder
63
Wheezing
61
Pneumonia
46
Hypersensitivity
43
Bronchospasm
39
Bronchiectasis
35
Pulmonary Fibrosis
30
Chronic Obstructive Airways Disease
28
Multiple Allergies
21
Obstructive Airways Disorder
20
Ill-defined Disorder
20
Asthma Exercise Induced
19
Bronchial Hyperreactivity
17
Nasopharyngitis
16
Bronchopneumopathy
14
Respiratory Failure
14
Bronchial Disorder
14
Sarcoidosis
9
Interstitial Lung Disease
9
Lung Neoplasm Malignant
8
Foetal Exposure During Pregnancy
8
Fatigue
8
Upper Respiratory Tract Infection
8
Asbestosis
7
Respiratory Tract Infection
7
Pulmonary Congestion
7
Seasonal Allergy
7
Allergic Bronchitis
7
Cystic Fibrosis
7
Hypertension
6
Sinusitis
6
Dyspnoea Exertional
6
Pulmonary Hypertension
6
Pulmonary Oedema
6
Rheumatoid Arthritis
5
Total Lung Capacity Decreased
5
Lung Carcinoma Cell Type Unspecifie...
5
Lung Infection
5
Sleep Apnoea Syndrome
5
Infection
5
Prophylaxis
4

Drug Labels

LabelLabelerEffective
SymbicortAstraZeneca LP17-JUN-10
ForadilMerck Sharp & Dohme Corp.30-NOV-12
DuleraMerck Sharp & Dohme Corp.15-JAN-13
PerforomistMylan Specialty30-JAN-13

Formoterol Fumarate Case Reports

What Formoterol Fumarate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Formoterol Fumarate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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