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PROVENTIL HFA

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Proventil Hfa Adverse Events Reported to the FDA Over Time

How are Proventil Hfa adverse event reports trending over time?

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

Most Common Proventil Hfa Adverse Events Reported to the FDA

What are the most common Proventil Hfa adverse events reported to the FDA?

Drug Ineffective
152 (11.45%)
Product Quality Issue
74 (5.58%)
Asthma
70 (5.28%)
Dyspnoea
59 (4.45%)
Condition Aggravated
43 (3.24%)
Drug Effect Decreased
39 (2.94%)
Headache
26 (1.96%)
Death
21 (1.58%)
Loss Of Consciousness
21 (1.58%)
Heart Rate Increased
19 (1.43%)
Dizziness
18 (1.36%)
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Device Failure
17 (1.28%)
Device Malfunction
17 (1.28%)
Therapeutic Response Unexpected Wit...
17 (1.28%)
Chest Discomfort
13 (.98%)
Product Substitution Issue
13 (.98%)
Cough
12 (.9%)
Asthenia
11 (.83%)
Chronic Obstructive Pulmonary Disea...
11 (.83%)
Palpitations
11 (.83%)
Pneumonia
11 (.83%)
Feeling Abnormal
10 (.75%)
Wheezing
10 (.75%)
Anaphylactic Reaction
9 (.68%)
Bronchitis
9 (.68%)
Bronchospasm
9 (.68%)
Chest Pain
9 (.68%)
Fear
9 (.68%)
Malaise
9 (.68%)
Nausea
9 (.68%)
No Therapeutic Response
9 (.68%)
Anxiety
8 (.6%)
Hypersensitivity
8 (.6%)
Lung Disorder
8 (.6%)
Vomiting
8 (.6%)
Blood Pressure Increased
7 (.53%)
Cerebrovascular Accident
7 (.53%)
Drug Hypersensitivity
7 (.53%)
Economic Problem
7 (.53%)
Pharyngeal Oedema
7 (.53%)
Respiratory Arrest
7 (.53%)
Stress
7 (.53%)
Therapeutic Product Ineffective
7 (.53%)
Throat Irritation
7 (.53%)
Tremor
7 (.53%)
Emphysema
6 (.45%)
Incorrect Dose Administered
6 (.45%)
Nightmare
6 (.45%)
Product Packaging Quantity Issue
6 (.45%)
Quality Of Life Decreased
6 (.45%)
Abnormal Dreams
5 (.38%)
Atrial Fibrillation
5 (.38%)
Cardiac Failure
5 (.38%)
Disorientation
5 (.38%)
Fall
5 (.38%)
Medical Device Complication
5 (.38%)
Overdose
5 (.38%)
Oxygen Saturation Decreased
5 (.38%)
Viral Infection
5 (.38%)
Wrong Technique In Drug Usage Proce...
5 (.38%)
Back Pain
4 (.3%)
Hypoaesthesia Oral
4 (.3%)
Ill-defined Disorder
4 (.3%)
Increased Upper Airway Secretion
4 (.3%)
Insomnia
4 (.3%)
Product Formulation Issue
4 (.3%)
Pruritus
4 (.3%)
Rash
4 (.3%)
Reaction To Drug Excipients
4 (.3%)
Swollen Tongue
4 (.3%)
Uterine Disorder
4 (.3%)
Activities Of Daily Living Impaired
3 (.23%)
Blood Glucose Abnormal
3 (.23%)
Burning Sensation
3 (.23%)
Convulsion
3 (.23%)
Device Ineffective
3 (.23%)
Drug Exposure During Pregnancy
3 (.23%)
Foreign Body Trauma
3 (.23%)
General Physical Health Deteriorati...
3 (.23%)
Hyperhidrosis
3 (.23%)
Influenza
3 (.23%)
Lip Swelling
3 (.23%)
Medication Error
3 (.23%)
Muscle Spasms
3 (.23%)
Myocardial Infarction
3 (.23%)
Nasal Congestion
3 (.23%)
Nervous System Disorder
3 (.23%)
Oedema Peripheral
3 (.23%)
Off Label Use
3 (.23%)
Oropharyngeal Pain
3 (.23%)
Pain In Extremity
3 (.23%)
Stevens-johnson Syndrome
3 (.23%)
Swelling Face
3 (.23%)
Tachycardia
3 (.23%)
Treatment Noncompliance
3 (.23%)
Underdose
3 (.23%)
Weight Increased
3 (.23%)
Aggression
2 (.15%)
Antepartum Haemorrhage
2 (.15%)
Aphonia
2 (.15%)
Apnoea
2 (.15%)

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This graph shows the top adverse events submitted to the FDA for Proventil Hfa, 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 Proventil Hfa 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 Proventil Hfa

What are the most common Proventil Hfa adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Proventil Hfa, 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 Proventil Hfa 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 Proventil Hfa According to Those Reporting Adverse Events

Why are people taking Proventil Hfa, according to those reporting adverse events to the FDA?

Asthma
293
Drug Use For Unknown Indication
132
Chronic Obstructive Pulmonary Disea...
61
Dyspnoea
34
Product Used For Unknown Indication
32
Wheezing
22
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Emphysema
7
Bronchitis
7
Cough
5
Asthma Exercise Induced
4
Multiple Allergies
3
Pulmonary Congestion
3
Respiratory Disorder
3
Lung Disorder
2
Chronic Obstructive Airways Disease
2
Bronchospasm
2
Bronchitis Chronic
2
Inhalation Therapy
2
Hypersensitivity
2
Asbestosis
2
Asthmatic Crisis
1
Asthenia
1
Lung Neoplasm Malignant
1
Lower Respiratory Tract Infection
1
Bronchial Hyperreactivity
1
Ill-defined Disorder
1
Sarcoidosis
1
Obstructive Airways Disorder
1
Panic Attack
1
Drug Hypersensitivity
1
Seasonal Allergy
1

Drug Labels

LabelLabelerEffective
Proventil HfaPhysicians Total Care, Inc.30-OCT-09
Proventil HfaLake Erie Medical DBA Quality Care Products LLC17-JAN-11
Proventil HfaRebel Distributors Corp.04-OCT-11
Proventil HfaMerck Sharp & Dohme Corp.02-JUL-12

Proventil Hfa Case Reports

What Proventil Hfa 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 Proventil Hfa. 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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