PROVENTIL HFA

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?

Therapeutic And Nontherapeutic Effe...	233 (17.56%)
Respiratory	121 (9.12%)
Bronchial Disorders	101 (7.61%)
Product Quality Issues	99 (7.46%)
Neurological	59 (4.45%)
Procedural And Device Related Injur...	42 (3.17%)
Cardiac And Vascular Investigations	33 (2.49%)
Anxiety Disorders	30 (2.26%)
Medication Errors	30 (2.26%)
Allergic Conditions	29 (2.19%)
Headaches	29 (2.19%)
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Infections - Pathogen Unspecified	29 (2.19%)
Gastrointestinal Signs	23 (1.73%)
Fatal Outcomes	21 (1.58%)
Sleep Disorders	18 (1.36%)
Upper Respiratory Tract Disorders	18 (1.36%)
Cardiac Arrhythmias	17 (1.28%)
Epidermal And Dermal Conditions	16 (1.21%)
Cardiac Disorder Signs	12 (.9%)
Injuries	10 (.75%)
Movement Disorders	10 (.75%)
Lower Respiratory Tract Disorders	9 (.68%)
Metabolic, Nutritional And Blood Ga...	9 (.68%)
Musculoskeletal And Connective Tiss...	8 (.6%)
Oral Soft Tissue Conditions	8 (.6%)
Viral Infectious	8 (.6%)
Central Nervous System Vascular	7 (.53%)
Chemical Injury And Poisoning	7 (.53%)
Economic And Housing Issues	7 (.53%)
Seizures	7 (.53%)
Therapeutic Procedures And Supporti...	7 (.53%)
Deliria	6 (.45%)
Heart Failures	6 (.45%)
Investigations, Imaging And Histopa...	6 (.45%)
Lifestyle Issues	6 (.45%)
Joint	5 (.38%)
Muscle	5 (.38%)
Physical Examination Topics	5 (.38%)
Depressed Mood Disorders	4 (.3%)
Mood Disorders	4 (.3%)
Tongue Conditions	4 (.3%)
Uterine, Pelvic And Broad Ligament	4 (.3%)
Aural	3 (.23%)
Coronary Artery	3 (.23%)
Gastrointestinal Motility And Defec...	3 (.23%)
Hepatobiliary Therapeutic Procedure...	3 (.23%)
Injuries By Physical Agents	3 (.23%)
Inner Ear And Viiith Cranial Nerve	3 (.23%)
Lipid Analyses	3 (.23%)
Renal Disorders	3 (.23%)
Skin Appendage Conditions	3 (.23%)
Vascular	3 (.23%)
Angiedema And Urticaria	2 (.15%)
Appetite And General Nutritional	2 (.15%)
Bone And Joint Injuries	2 (.15%)
Dissociative	2 (.15%)
Electrolyte And Fluid Balance Condi...	2 (.15%)
Gastrointestinal Stenosis And Obstr...	2 (.15%)
Head And Neck Therapeutic Procedure...	2 (.15%)
Maternal Complications Of Pregnancy	2 (.15%)
Mental Impairment	2 (.15%)
Miscellaneous And Site Unspecified ...	2 (.15%)
Musculoskeletal And Connective Tiss...	2 (.15%)
Musculoskeletal And Connective Tiss...	2 (.15%)
Neonatal And Perinatal Conditions	2 (.15%)
Peripheral Neuropathies	2 (.15%)
Personality Disorders	2 (.15%)
Renal And Urinary Tract Disorders C...	2 (.15%)
Respiratory And Pulmonary Investiga...	2 (.15%)
Suicidal And Self-injurious Behavio...	2 (.15%)
Vascular Hypertensive	2 (.15%)
Vision	2 (.15%)
Bladder And Bladder Neck Disorders	1 (.08%)
Changes In Physical Activity	1 (.08%)
Congenital And Hereditary	1 (.08%)
Decreased And Nonspecific Blood Pre...	1 (.08%)
Disturbances In Thinking	1 (.08%)
Enzyme	1 (.08%)
External Ear Disorders	1 (.08%)
Eye	1 (.08%)
Fetal Complications	1 (.08%)
Fungal Infectious	1 (.08%)
Gastrointestinal Inflammatory Condi...	1 (.08%)
Glucose Metabolism Disorders	1 (.08%)
Immunology And Allergy	1 (.08%)
Manic And Bipolar Mood Disorders	1 (.08%)
Maternal Complications Of Labour An...	1 (.08%)
Mesotheliomas	1 (.08%)
Neonatal Respiratory	1 (.08%)
Ocular Infections, Irritations And ...	1 (.08%)
Placental, Amniotic And Cavity Diso...	1 (.08%)
Psychiatric	1 (.08%)
Psychiatric And Behavioural Symptom...	1 (.08%)
Reproductive Tract And Breast Disor...	1 (.08%)
Respiratory And Mediastinal Neoplas...	1 (.08%)
Schizophrenia And Other Psychotic	1 (.08%)
Sexual Function And Fertility	1 (.08%)
Thoracic Disorders	1 (.08%)

Share/Embed Graph Export Data

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.