PULMICORT

Pulmicort Adverse Events Reported to the FDA Over Time

How are Pulmicort adverse event reports trending over time?

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

Most Common Pulmicort Adverse Events Reported to the FDA

What are the most common Pulmicort adverse events reported to the FDA?

Dyspnoea	812 (5.46%)
Asthma	603 (4.06%)
Drug Ineffective	509 (3.43%)
Cough	445 (2.99%)
Drug Dose Omission	328 (2.21%)
Malaise	296 (1.99%)
Off Label Use	249 (1.68%)
Dysphonia	213 (1.43%)
Wheezing	187 (1.26%)
Chest Discomfort	165 (1.11%)
Pneumonia	165 (1.11%)
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Dizziness	137 (.92%)
Chronic Obstructive Pulmonary Disea...	127 (.85%)
Insomnia	113 (.76%)
Medication Error	111 (.75%)
Headache	108 (.73%)
Chest Pain	106 (.71%)
Nasopharyngitis	105 (.71%)
Throat Irritation	104 (.7%)
Fatigue	98 (.66%)
Dysgeusia	95 (.64%)
Rhinorrhoea	95 (.64%)
Bronchitis	94 (.63%)
Incorrect Dose Administered	91 (.61%)
Tremor	88 (.59%)
Nausea	85 (.57%)
Anxiety	77 (.52%)
Condition Aggravated	77 (.52%)
Increased Upper Airway Secretion	77 (.52%)
Vomiting	77 (.52%)
Weight Decreased	75 (.5%)
Intentional Drug Misuse	73 (.49%)
Diarrhoea	72 (.48%)
Oropharyngeal Pain	71 (.48%)
Dry Mouth	70 (.47%)
Cataract	69 (.46%)
Psychomotor Hyperactivity	69 (.46%)
Pyrexia	69 (.46%)
Pruritus	68 (.46%)
Gastrooesophageal Reflux Disease	66 (.44%)
Heart Rate Increased	66 (.44%)
Rash	66 (.44%)
Feeling Abnormal	64 (.43%)
Fall	60 (.4%)
Weight Increased	60 (.4%)
Blood Pressure Increased	59 (.4%)
Nasal Congestion	59 (.4%)
Circumstance Or Information Capable...	58 (.39%)
Sinusitis	57 (.38%)
Blood Glucose Increased	56 (.38%)
Asthenia	54 (.36%)
Ill-defined Disorder	54 (.36%)
Lung Disorder	53 (.36%)
Pain	53 (.36%)
Glaucoma	51 (.34%)
Nervousness	51 (.34%)
Hypersensitivity	49 (.33%)
Palpitations	48 (.32%)
Dyspepsia	46 (.31%)
Urticaria	46 (.31%)
Muscle Spasms	45 (.3%)
Oedema Peripheral	44 (.3%)
Wrong Technique In Drug Usage Proce...	44 (.3%)
Diabetes Mellitus	43 (.29%)
Aggression	42 (.28%)
Hypertension	42 (.28%)
Overdose	41 (.28%)
Respiratory Disorder	41 (.28%)
Abdominal Pain Upper	39 (.26%)
Candidiasis	38 (.26%)
Depression	38 (.26%)
Drug Administration Error	38 (.26%)
Abnormal Behaviour	37 (.25%)
Drug Effect Decreased	37 (.25%)
Oxygen Saturation Decreased	37 (.25%)
Abdominal Distension	36 (.24%)
Adverse Event	36 (.24%)
Arthralgia	36 (.24%)
Pain In Extremity	36 (.24%)
Drug Exposure During Pregnancy	35 (.24%)
Epistaxis	35 (.24%)
Muscular Weakness	35 (.24%)
Back Pain	34 (.23%)
Choking	34 (.23%)
Irritability	33 (.22%)
Stomatitis	33 (.22%)
Vision Blurred	33 (.22%)
Erythema	32 (.22%)
Gait Disturbance	32 (.22%)
Throat Tightness	32 (.22%)
Agitation	30 (.2%)
Alopecia	30 (.2%)
Contusion	30 (.2%)
Drug Hypersensitivity	30 (.2%)
Glossodynia	30 (.2%)
Oral Candidiasis	30 (.2%)
Tachycardia	30 (.2%)
Activities Of Daily Living Impaired	29 (.2%)
Arthritis	29 (.2%)
Flatulence	29 (.2%)
Loss Of Consciousness	29 (.2%)

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

What are the most common Pulmicort adverse events reported to the FDA?

Respiratory	2246 (15.11%)
Bronchial Disorders	968 (6.51%)
Medication Errors	861 (5.79%)
Therapeutic And Nontherapeutic Effe...	689 (4.64%)
Infections - Pathogen Unspecified	674 (4.54%)
Neurological	504 (3.39%)
Gastrointestinal Signs	438 (2.95%)
Epidermal And Dermal Conditions	379 (2.55%)
Therapeutic Procedures And Supporti...	278 (1.87%)
Anxiety Disorders	201 (1.35%)
Upper Respiratory Tract Disorders	201 (1.35%)
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Injuries	194 (1.31%)
Movement Disorders	186 (1.25%)
Gastrointestinal Motility And Defec...	171 (1.15%)
Sleep Disorders	171 (1.15%)
Physical Examination Topics	170 (1.14%)
Oral Soft Tissue Conditions	169 (1.14%)
Cardiac And Vascular Investigations	167 (1.12%)
Allergic Conditions	155 (1.04%)
Musculoskeletal And Connective Tiss...	143 (.96%)
Joint	139 (.94%)
Fungal Infectious	135 (.91%)
Muscle	126 (.85%)
Metabolic, Nutritional And Blood Ga...	123 (.83%)
Headaches	122 (.82%)
Skin Appendage Conditions	106 (.71%)
Tongue Conditions	98 (.66%)
Lower Respiratory Tract Disorders	96 (.65%)
Cardiac Arrhythmias	92 (.62%)
Viral Infectious	92 (.62%)
Cardiac Disorder Signs	88 (.59%)
Salivary Gland Conditions	88 (.59%)
Vision	86 (.58%)
Appetite And General Nutritional	85 (.57%)
Psychiatric	83 (.56%)
Anterior Eye Structural Change, Dep...	75 (.5%)
Glucose Metabolism Disorders	73 (.49%)
Eye	72 (.48%)
Mood Disorders	72 (.48%)
Bone Disorders	71 (.48%)
Mental Impairment	71 (.48%)
Bone And Joint Injuries	70 (.47%)
Body Temperature Conditions	69 (.46%)
Ocular Infections, Irritations And ...	69 (.46%)
Dental And Gingival Conditions	68 (.46%)
Lifestyle Issues	68 (.46%)
Personality Disorders	61 (.41%)
Urinary Tract Signs	60 (.4%)
Angiedema And Urticaria	56 (.38%)
Product Quality Issues	53 (.36%)
Respiratory And Pulmonary Investiga...	53 (.36%)
Glaucoma And Ocular Hypertension	52 (.35%)
Depressed Mood Disorders	50 (.34%)
Electrolyte And Fluid Balance Condi...	50 (.34%)
Bacterial Infectious	48 (.32%)
Gastrointestinal Conditions	48 (.32%)
Vascular Hypertensive	48 (.32%)
Procedural And Device Related Injur...	45 (.3%)
Vascular	43 (.29%)
Psychiatric And Behavioural Symptom...	42 (.28%)
Coronary Artery	41 (.28%)
Chemical Injury And Poisoning	40 (.27%)
Hematology Investigations	40 (.27%)
Renal Disorders	38 (.26%)
Thyroid Gland	38 (.26%)
Central Nervous System Vascular	37 (.25%)
Disturbances In Thinking	35 (.24%)
Hearing	31 (.21%)
Changes In Physical Activity	29 (.2%)
Cranial Nerve Disorders	28 (.19%)
Hepatic And Hepatobiliary	28 (.19%)
Fatal Outcomes	27 (.18%)
Respiratory And Mediastinal Neoplas...	27 (.18%)
Skin Vascular Abnormalities	27 (.18%)
Heart Failures	26 (.17%)
Miscellaneous And Site Unspecified ...	26 (.17%)
Peripheral Neuropathies	25 (.17%)
Seizures	25 (.17%)
Aural	23 (.15%)
Embolism And Thrombosis	22 (.15%)
Hepatobiliary	22 (.15%)
Deliria	21 (.14%)
Ocular Neuromuscular	20 (.13%)
Adrenal Gland	19 (.13%)
Water, Electrolyte And Mineral	19 (.13%)
White Blood Cell	19 (.13%)
Ocular Structural Change, Deposit A...	18 (.12%)
Suicidal And Self-injurious Behavio...	18 (.12%)
Decreased And Nonspecific Blood Pre...	17 (.11%)
Investigations, Imaging And Histopa...	17 (.11%)
Food Intolerance Syndromes	15 (.1%)
Gastrointestinal Ulceration And Per...	15 (.1%)
Immune	15 (.1%)
Ocular Sensory Symptoms	15 (.1%)
Pulmonary Vascular	15 (.1%)
Spleen, Lymphatic And Reticulendoth...	15 (.1%)
Tendon, Ligament And Cartilage	15 (.1%)
Endocrine Investigations	14 (.09%)
Musculoskeletal And Soft Tissue Inv...	14 (.09%)
Platelet	14 (.09%)
Anemias Nonhemolytic And Marrow Dep...	13 (.09%)

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