BUDESONIDE

Budesonide Adverse Events Reported to the FDA Over Time

How are Budesonide adverse event reports trending over time?

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

Most Common Budesonide Adverse Events Reported to the FDA

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

Dyspnoea	72 (2.49%)
Asthma	62 (2.14%)
Drug Ineffective	45 (1.56%)
Fatigue	43 (1.49%)
Drug Interaction	32 (1.11%)
Vomiting	28 (.97%)
Pneumonia	27 (.93%)
Adrenal Insufficiency	25 (.86%)
Diarrhoea	25 (.86%)
Abdominal Pain	23 (.8%)
Malaise	23 (.8%)
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Nausea	23 (.8%)
Back Pain	22 (.76%)
Chest Pain	22 (.76%)
Cough	21 (.73%)
Off Label Use	21 (.73%)
Asthenia	19 (.66%)
Condition Aggravated	18 (.62%)
Tachycardia	18 (.62%)
Wheezing	18 (.62%)
Drug Exposure During Pregnancy	17 (.59%)
Fall	17 (.59%)
Insomnia	17 (.59%)
Bronchitis	16 (.55%)
Chronic Obstructive Pulmonary Disea...	16 (.55%)
Hypertension	16 (.55%)
Renal Failure	16 (.55%)
Weight Increased	16 (.55%)
Abdominal Pain Upper	14 (.48%)
Tremor	14 (.48%)
Death	13 (.45%)
Growth Retardation	13 (.45%)
Headache	13 (.45%)
Pruritus	13 (.45%)
Sepsis	13 (.45%)
Anxiety	12 (.41%)
Dehydration	12 (.41%)
Dyspepsia	12 (.41%)
Hypersensitivity	12 (.41%)
Rhabdomyolysis	12 (.41%)
Abdominal Distension	11 (.38%)
Ankle Fracture	11 (.38%)
Blood Pressure Increased	11 (.38%)
Cushingoid	11 (.38%)
Electrolyte Imbalance	11 (.38%)
General Physical Health Deteriorati...	11 (.38%)
Pyrexia	11 (.38%)
Respiratory Failure	11 (.38%)
Abnormal Behaviour	10 (.35%)
Cataract	10 (.35%)
Drug Hypersensitivity	10 (.35%)
Dysphonia	10 (.35%)
Foetal Distress Syndrome	10 (.35%)
Gastrointestinal Haemorrhage	10 (.35%)
Lung Infection	10 (.35%)
Neuroleptic Malignant Syndrome	10 (.35%)
Oedema Peripheral	10 (.35%)
Rash	10 (.35%)
Septic Shock	10 (.35%)
Swelling Face	10 (.35%)
Adrenal Suppression	9 (.31%)
Bronchospasm	9 (.31%)
Caesarean Section	9 (.31%)
Confusional State	9 (.31%)
Gastric Ulcer	9 (.31%)
Heart Rate Increased	9 (.31%)
Hypokalaemia	9 (.31%)
Lung Neoplasm Malignant	9 (.31%)
Migraine	9 (.31%)
Osteoporosis	9 (.31%)
Pancreatitis Acute	9 (.31%)
Product Substitution Issue	9 (.31%)
Alanine Aminotransferase Increased	8 (.28%)
Cyanosis	8 (.28%)
Gait Disturbance	8 (.28%)
Maternal Drugs Affecting Foetus	8 (.28%)
Tubulointerstitial Nephritis	8 (.28%)
Aggression	7 (.24%)
Arthralgia	7 (.24%)
Aspartate Aminotransferase Increase...	7 (.24%)
Aspiration	7 (.24%)
Colitis	7 (.24%)
Contusion	7 (.24%)
Dizziness	7 (.24%)
Dry Mouth	7 (.24%)
Epidural Lipomatosis	7 (.24%)
Fibromyalgia	7 (.24%)
Haemodialysis	7 (.24%)
Hepatic Infarction	7 (.24%)
Hepatorenal Syndrome	7 (.24%)
Hypovolaemia	7 (.24%)
Labile Blood Pressure	7 (.24%)
Palpitations	7 (.24%)
Rash Generalised	7 (.24%)
Visual Field Defect	7 (.24%)
Agitation	6 (.21%)
Aphasia	6 (.21%)
Atrial Septal Defect	6 (.21%)
Blood Cortisol Decreased	6 (.21%)
Coagulopathy	6 (.21%)
Deafness	6 (.21%)

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

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

Respiratory	184 (6.36%)
Gastrointestinal Signs	132 (4.56%)
Infections - Pathogen Unspecified	124 (4.29%)
Bronchial Disorders	111 (3.84%)
Therapeutic And Nontherapeutic Effe...	91 (3.15%)
Epidermal And Dermal Conditions	88 (3.04%)
Neurological	75 (2.59%)
Hepatic And Hepatobiliary	67 (2.32%)
Adrenal Gland	52 (1.8%)
Electrolyte And Fluid Balance Condi...	50 (1.73%)
Musculoskeletal And Connective Tiss...	47 (1.62%)
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Muscle	40 (1.38%)
Cardiac And Vascular Investigations	39 (1.35%)
Cardiac Arrhythmias	39 (1.35%)
Viral Infectious	38 (1.31%)
Medication Errors	36 (1.24%)
Gastrointestinal Motility And Defec...	35 (1.21%)
Injuries	34 (1.18%)
Renal Disorders	33 (1.14%)
Physical Examination Topics	31 (1.07%)
Anxiety Disorders	30 (1.04%)
Upper Respiratory Tract Disorders	30 (1.04%)
Hepatobiliary	29 (1%)
Allergic Conditions	28 (.97%)
Chemical Injury And Poisoning	28 (.97%)
Hematology Investigations	27 (.93%)
Movement Disorders	27 (.93%)
Decreased And Nonspecific Blood Pre...	24 (.83%)
Headaches	24 (.83%)
Therapeutic Procedures And Supporti...	24 (.83%)
Lower Respiratory Tract Disorders	23 (.8%)
Sleep Disorders	23 (.8%)
Bacterial Infectious	22 (.76%)
Fungal Infectious	21 (.73%)
Gastrointestinal Hemorrhages	21 (.73%)
Skin Vascular Abnormalities	20 (.69%)
Appetite And General Nutritional	19 (.66%)
Mental Impairment	19 (.66%)
Skin Appendage Conditions	19 (.66%)
White Blood Cell	19 (.66%)
Cardiac Disorder Signs	18 (.62%)
Joint	18 (.62%)
Neuromuscular	18 (.62%)
Respiratory And Mediastinal Neoplas...	18 (.62%)
Bone Disorders	17 (.59%)
Endocrine Investigations	17 (.59%)
Metabolic, Nutritional And Blood Ga...	17 (.59%)
Bone And Joint Injuries	16 (.55%)
Exocrine Pancreas Conditions	16 (.55%)
Gastrointestinal Ulceration And Per...	16 (.55%)
Vascular Hypertensive	16 (.55%)
Water, Electrolyte And Mineral	16 (.55%)
Fatal Outcomes	15 (.52%)
Fetal Complications	15 (.52%)
Oral Soft Tissue Conditions	15 (.52%)
Lifestyle Issues	14 (.48%)
Anterior Eye Structural Change, Dep...	13 (.45%)
Central Nervous System Vascular	13 (.45%)
Body Temperature Conditions	12 (.41%)
Deliria	11 (.38%)
Procedural And Device Related Injur...	11 (.38%)
Product Quality Issues	11 (.38%)
Psychiatric	11 (.38%)
Dental And Gingival Conditions	10 (.35%)
Gastrointestinal Inflammatory Condi...	10 (.35%)
Glucose Metabolism Disorders	10 (.35%)
Neonatal And Perinatal Conditions	10 (.35%)
Neurological, Special Senses And Ps...	10 (.35%)
Personality Disorders	10 (.35%)
Psychiatric And Behavioural Symptom...	10 (.35%)
Vision	10 (.35%)
Anemias Nonhemolytic And Marrow Dep...	9 (.31%)
Angiedema And Urticaria	9 (.31%)
Cardiac And Vascular Disorders Cong...	9 (.31%)
Embolism And Thrombosis	9 (.31%)
Enzyme	9 (.31%)
Hearing	9 (.31%)
Immune	9 (.31%)
Nephropathies	9 (.31%)
Obstetric And Gynecological Therape...	9 (.31%)
Tendon, Ligament And Cartilage	9 (.31%)
Arteriosclerosis, Stenosis, Vascula...	8 (.28%)
Coronary Artery	8 (.28%)
Hematological And Lymphoid Tissue T...	8 (.28%)
Spinal Cord And Nerve Root	8 (.28%)
Tongue Conditions	8 (.28%)
Toxicology And Therapeutic Drug Mon...	8 (.28%)
Acid-base	7 (.24%)
Encephalopathies	7 (.24%)
Immunology And Allergy	7 (.24%)
Mesotheliomas	7 (.24%)
Neurological Disorders Of The Eye	7 (.24%)
Pulmonary Vascular	7 (.24%)
Salivary Gland Conditions	7 (.24%)
Vascular	7 (.24%)
Coagulopathies And Bleeding Diathes...	6 (.21%)
Depressed Mood Disorders	6 (.21%)
Disturbances In Thinking	6 (.21%)
Gastrointestinal	6 (.21%)
Gastrointestinal Stenosis And Obstr...	6 (.21%)
Immunodeficiency Syndromes	6 (.21%)

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