PRIMATENE MIST

Primatene Mist Adverse Events Reported to the FDA Over Time

How are Primatene Mist adverse event reports trending over time?

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

Most Common Primatene Mist Adverse Events Reported to the FDA

What are the most common Primatene Mist adverse events reported to the FDA?

Drug Ineffective	44 (9.8%)
Asthma	18 (4.01%)
Dyspnoea	16 (3.56%)
Chest Pain	14 (3.12%)
Heart Rate Increased	14 (3.12%)
Drug Effect Decreased	11 (2.45%)
Dizziness	9 (2%)
Headache	8 (1.78%)
Incorrect Dose Administered	8 (1.78%)
Cough	7 (1.56%)
Drug Screen Positive	7 (1.56%)
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No Therapeutic Response	7 (1.56%)
Overdose	7 (1.56%)
Vomiting	7 (1.56%)
Condition Aggravated	6 (1.34%)
Drug Dependence	6 (1.34%)
Loss Of Consciousness	6 (1.34%)
Throat Irritation	6 (1.34%)
Lung Disorder	5 (1.11%)
Malaise	5 (1.11%)
Nausea	5 (1.11%)
Nervousness	5 (1.11%)
Anxiety	4 (.89%)
Blood Pressure Increased	4 (.89%)
Death	4 (.89%)
Device Failure	4 (.89%)
Feeling Abnormal	4 (.89%)
Myocardial Infarction	4 (.89%)
Oxygen Saturation Decreased	4 (.89%)
Sputum Discoloured	4 (.89%)
Wheezing	4 (.89%)
Alopecia	3 (.67%)
Arthralgia	3 (.67%)
Caustic Injury	3 (.67%)
Device Breakage	3 (.67%)
Drug Abuser	3 (.67%)
Glossodynia	3 (.67%)
Incoherent	3 (.67%)
Incorrect Route Of Drug Administrat...	3 (.67%)
Infection	3 (.67%)
Palpitations	3 (.67%)
Treatment Noncompliance	3 (.67%)
Weight Increased	3 (.67%)
Abdominal Pain Upper	2 (.45%)
Accidental Overdose	2 (.45%)
Amphetamines Positive	2 (.45%)
Asthenia	2 (.45%)
Atrial Fibrillation	2 (.45%)
Cardiac Arrest	2 (.45%)
Cerebrovascular Accident	2 (.45%)
Chest Discomfort	2 (.45%)
Circulatory Collapse	2 (.45%)
Contusion	2 (.45%)
Device Malfunction	2 (.45%)
Drug Hypersensitivity	2 (.45%)
Drug Screen False Positive	2 (.45%)
Eye Injury	2 (.45%)
Haematemesis	2 (.45%)
Hot Flush	2 (.45%)
Hyperventilation	2 (.45%)
Ill-defined Disorder	2 (.45%)
Insomnia	2 (.45%)
Metabolic Acidosis	2 (.45%)
Mood Swings	2 (.45%)
Pharyngeal Oedema	2 (.45%)
Pneumonia Primary Atypical	2 (.45%)
Poor Quality Drug Administered	2 (.45%)
Reaction To Drug Excipients	2 (.45%)
Respiratory Distress	2 (.45%)
Respiratory Tract Irritation	2 (.45%)
Retching	2 (.45%)
Rhinitis Allergic	2 (.45%)
Sinusitis	2 (.45%)
Tremor	2 (.45%)
Wrong Technique In Drug Usage Proce...	2 (.45%)
Accidental Drug Intake By Child	1 (.22%)
Accidental Exposure	1 (.22%)
Adverse Drug Reaction	1 (.22%)
Adverse Event	1 (.22%)
Aggression	1 (.22%)
Alanine Aminotransferase Increased	1 (.22%)
Alcoholism	1 (.22%)
Anaphylactic Reaction	1 (.22%)
Anger	1 (.22%)
Aphasia	1 (.22%)
Blindness Transient	1 (.22%)
Blood Alcohol Increased	1 (.22%)
Blood Bilirubin Increased	1 (.22%)
Blood Blister	1 (.22%)
Blood Pressure Systolic Increased	1 (.22%)
Bronchospasm	1 (.22%)
Burning Sensation	1 (.22%)
Cardio-respiratory Arrest	1 (.22%)
Cerebral Haemorrhage	1 (.22%)
Cerebral Thrombosis	1 (.22%)
Cheilitis	1 (.22%)
Choking	1 (.22%)
Choking Sensation	1 (.22%)
Cold Sweat	1 (.22%)
Dependence	1 (.22%)
Diabetes Mellitus	1 (.22%)

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This graph shows the top adverse events submitted to the FDA for Primatene Mist, 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 Primatene Mist 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 Primatene Mist

What are the most common Primatene Mist adverse events reported to the FDA?

Therapeutic And Nontherapeutic Effe...	66 (14.7%)
Respiratory	51 (11.36%)
Medication Errors	28 (6.24%)
Bronchial Disorders	23 (5.12%)
Neurological	23 (5.12%)
Cardiac And Vascular Investigations	22 (4.9%)
Gastrointestinal Signs	17 (3.79%)
Anxiety Disorders	12 (2.67%)
Toxicology And Therapeutic Drug Mon...	12 (2.67%)
Infections - Pathogen Unspecified	10 (2.23%)
Procedural And Device Related Injur...	10 (2.23%)
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Headaches	8 (1.78%)
Psychiatric	8 (1.78%)
Cardiac Arrhythmias	7 (1.56%)
Injuries	7 (1.56%)
Allergic Conditions	6 (1.34%)
Lifestyle Issues	6 (1.34%)
Skin Appendage Conditions	5 (1.11%)
Central Nervous System Vascular	4 (.89%)
Chemical Injury And Poisoning	4 (.89%)
Coronary Artery	4 (.89%)
Epidermal And Dermal Conditions	4 (.89%)
Fatal Outcomes	4 (.89%)
Joint	4 (.89%)
Metabolic, Nutritional And Blood Ga...	4 (.89%)
Upper Respiratory Tract Disorders	4 (.89%)
Cardiac Disorder Signs	3 (.67%)
Dental And Gingival Conditions	3 (.67%)
Mood Disorders	3 (.67%)
Oral Soft Tissue Conditions	3 (.67%)
Physical Examination Topics	3 (.67%)
Tongue Conditions	3 (.67%)
Acid-base	2 (.45%)
Decreased And Nonspecific Blood Pre...	2 (.45%)
Gastrointestinal Hemorrhages	2 (.45%)
Hepatobiliary	2 (.45%)
Movement Disorders	2 (.45%)
Sleep Disorders	2 (.45%)
Therapeutic Procedures And Supporti...	2 (.45%)
Vascular	2 (.45%)
Administration Site Reactions	1 (.22%)
Bacterial Infectious	1 (.22%)
Body Temperature Conditions	1 (.22%)
Bone And Joint Injuries	1 (.22%)
Changes In Physical Activity	1 (.22%)
Disturbances In Thinking	1 (.22%)
Economic And Housing Issues	1 (.22%)
Enzyme	1 (.22%)
Eye	1 (.22%)
Gastrointestinal Motility And Defec...	1 (.22%)
Glucose Metabolism Disorders	1 (.22%)
Hematology Investigations	1 (.22%)
Lower Respiratory Tract Disorders	1 (.22%)
Muscle	1 (.22%)
Musculoskeletal And Connective Tiss...	1 (.22%)
Ocular Infections, Irritations And ...	1 (.22%)
Personality Disorders	1 (.22%)
Product Quality Issues	1 (.22%)
Pulmonary Vascular	1 (.22%)
Salivary Gland Conditions	1 (.22%)
Vascular Hypertensive	1 (.22%)
Vision	1 (.22%)

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This graph shows the top categories of adverse events submitted to the FDA for Primatene Mist, 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 Primatene Mist 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.