GAVISCON

Gaviscon Adverse Events Reported to the FDA Over Time

How are Gaviscon adverse event reports trending over time?

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

Most Common Gaviscon Adverse Events Reported to the FDA

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

Dyspnoea	29 (3.54%)
Mesothelioma	29 (3.54%)
Cerebrovascular Accident	26 (3.17%)
Lung Neoplasm Malignant	25 (3.05%)
Cough	23 (2.8%)
Drug Interaction	18 (2.2%)
Drug Exposure During Pregnancy	16 (1.95%)
Anaemia	15 (1.83%)
Cardiac Failure	14 (1.71%)
Acute Respiratory Distress Syndrome	12 (1.46%)
Eosinophilic Pneumonia	12 (1.46%)
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Haemorrhage	11 (1.34%)
Respiratory Failure	10 (1.22%)
Disorientation	8 (.98%)
Drug Ineffective	8 (.98%)
Gastrooesophageal Reflux Disease	8 (.98%)
Necrotising Colitis	8 (.98%)
Premature Baby	8 (.98%)
Condition Aggravated	7 (.85%)
Hypernatraemia	7 (.85%)
Pancreatitis Acute	7 (.85%)
Peritonitis	7 (.85%)
Pulmonary Fibrosis	7 (.85%)
Renal Failure Acute	7 (.85%)
Caesarean Section	6 (.73%)
Coagulopathy	6 (.73%)
Confusional State	6 (.73%)
Constipation	6 (.73%)
Convulsion	6 (.73%)
Fall	6 (.73%)
Thrombocytopenia	6 (.73%)
Feeling Abnormal	5 (.61%)
Prothrombin Time Abnormal	5 (.61%)
Anaphylactic Reaction	4 (.49%)
Apgar Score Low	4 (.49%)
Blood Creatinine Increased	4 (.49%)
Breast Cancer	4 (.49%)
Cytolytic Hepatitis	4 (.49%)
Death	4 (.49%)
Drug Rash With Eosinophilia And Sys...	4 (.49%)
Dyspepsia	4 (.49%)
Epilepsy	4 (.49%)
Failure Of Implant	4 (.49%)
Fanconi Syndrome	4 (.49%)
Hyponatraemia	4 (.49%)
Hypoxia	4 (.49%)
Nonspecific Reaction	4 (.49%)
Pharyngeal Oedema	4 (.49%)
Poor Quality Drug Administered	4 (.49%)
Pruritus	4 (.49%)
Rash	4 (.49%)
Rash Erythematous	4 (.49%)
Respiratory Arrest	4 (.49%)
Sleep Disorder	4 (.49%)
Tooth Fracture	4 (.49%)
Abdominal Discomfort	3 (.37%)
Alanine Aminotransferase Increased	3 (.37%)
Back Pain	3 (.37%)
Cardiac Tamponade	3 (.37%)
Cardiospasm	3 (.37%)
Chest Pain	3 (.37%)
Coarctation Of The Aorta	3 (.37%)
Deep Vein Thrombosis	3 (.37%)
Diarrhoea	3 (.37%)
Dizziness	3 (.37%)
Gamma-glutamyltransferase Increased	3 (.37%)
Hepatic Enzyme Increased	3 (.37%)
Hypersensitivity	3 (.37%)
Inflammation	3 (.37%)
Insomnia	3 (.37%)
International Normalised Ratio Incr...	3 (.37%)
Jaundice Cholestatic	3 (.37%)
Jaundice Neonatal	3 (.37%)
Lactic Acidosis	3 (.37%)
Myocardial Infarction	3 (.37%)
Nausea	3 (.37%)
Nephrolithiasis	3 (.37%)
Neutropenia	3 (.37%)
Pleural Effusion	3 (.37%)
Premature Labour	3 (.37%)
Psoriasis	3 (.37%)
Pulmonary Embolism	3 (.37%)
Pulmonary Infarction	3 (.37%)
Sudden Death	3 (.37%)
Talipes	3 (.37%)
Transposition Of The Great Vessels	3 (.37%)
Urticaria	3 (.37%)
Ventricular Septal Defect	3 (.37%)
Vomiting	3 (.37%)
Abdominal Pain	2 (.24%)
Abdominal Pain Upper	2 (.24%)
Angioedema	2 (.24%)
Aspartate Aminotransferase Increase...	2 (.24%)
Asthenia	2 (.24%)
Asthma	2 (.24%)
Biopsy Lymph Gland	2 (.24%)
Blood Alkaline Phosphatase Increase...	2 (.24%)
Blood Bilirubin Increased	2 (.24%)
Blood Pressure Increased	2 (.24%)
Breast Lump Removal	2 (.24%)
Congenital Aplastic Anaemia	2 (.24%)

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

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

Respiratory	81 (9.88%)
Lower Respiratory Tract Disorders	32 (3.9%)
Mesotheliomas	32 (3.9%)
Epidermal And Dermal Conditions	28 (3.41%)
Central Nervous System Vascular	27 (3.29%)
Respiratory And Mediastinal Neoplas...	27 (3.29%)
Therapeutic And Nontherapeutic Effe...	27 (3.29%)
Gastrointestinal Motility And Defec...	20 (2.44%)
Gastrointestinal Signs	20 (2.44%)
Chemical Injury And Poisoning	18 (2.2%)
Anemias Nonhemolytic And Marrow Dep...	16 (1.95%)
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Hematology Investigations	16 (1.95%)
Hepatobiliary	15 (1.83%)
Deliria	14 (1.71%)
Electrolyte And Fluid Balance Condi...	14 (1.71%)
Heart Failures	14 (1.71%)
Hepatic And Hepatobiliary	13 (1.59%)
Neonatal And Perinatal Conditions	13 (1.59%)
Neurological	13 (1.59%)
Injuries	12 (1.46%)
Vascular Hemorrhagic	12 (1.46%)
Gastrointestinal Inflammatory Condi...	11 (1.34%)
Seizures	11 (1.34%)
Allergic Conditions	10 (1.22%)
Medication Errors	10 (1.22%)
Cardiac And Vascular Disorders Cong...	9 (1.1%)
Coronary Artery	9 (1.1%)
Exocrine Pancreas Conditions	9 (1.1%)
Gastrointestinal Hemorrhages	9 (1.1%)
Renal And Urinary Tract Investigati...	9 (1.1%)
Fatal Outcomes	8 (.98%)
Gastrointestinal Ulceration And Per...	8 (.98%)
Infections - Pathogen Unspecified	8 (.98%)
Renal Disorders	8 (.98%)
Cardiac And Vascular Investigations	7 (.85%)
Coagulopathies And Bleeding Diathes...	7 (.85%)
Oral Soft Tissue Conditions	7 (.85%)
Peritoneal And Retroperitoneal Cond...	7 (.85%)
Platelet	7 (.85%)
Sleep Disorders	7 (.85%)
Angiedema And Urticaria	6 (.73%)
Obstetric And Gynecological Therape...	6 (.73%)
Pulmonary Vascular	6 (.73%)
White Blood Cell	6 (.73%)
Acid-base	5 (.61%)
Breast Neoplasms Malignant And Unsp...	5 (.61%)
Musculoskeletal And Connective Tiss...	5 (.61%)
Pericardial	5 (.61%)
Physical Examination Topics	5 (.61%)
Procedural And Device Related Injur...	5 (.61%)
Bronchial Disorders	4 (.49%)
Embolism And Thrombosis	4 (.49%)
Enzyme	4 (.49%)
Renal And Urinary Tract Disorders C...	4 (.49%)
Upper Respiratory Tract Disorders	4 (.49%)
Cardiac Arrhythmias	3 (.37%)
Gallbladder	3 (.37%)
Lifestyle Issues	3 (.37%)
Maternal Complications Of Labour An...	3 (.37%)
Maternal Complications Of Pregnancy	3 (.37%)
Musculoskeletal And Connective Tiss...	3 (.37%)
Pleural	3 (.37%)
Tongue Conditions	3 (.37%)
Urolithiases	3 (.37%)
Abortions And Stillbirth	2 (.24%)
Bacterial Infectious	2 (.24%)
Blood And Lymphatic System Disorder...	2 (.24%)
Body Temperature Conditions	2 (.24%)
Breast Therapeutic Procedures	2 (.24%)
Fungal Infectious	2 (.24%)
Headaches	2 (.24%)
Hemolyses And Related Conditions	2 (.24%)
Metabolic, Nutritional And Blood Ga...	2 (.24%)
Movement Disorders	2 (.24%)
Ocular Infections, Irritations And ...	2 (.24%)
Protein And Chemistry Analyses	2 (.24%)
Psychiatric	2 (.24%)
Skin Vascular Abnormalities	2 (.24%)
Abdominal Hernias And Other Abdomin...	1 (.12%)
Ancillary Infectious Topics	1 (.12%)
Anxiety Disorders	1 (.12%)
Appetite And General Nutritional	1 (.12%)
Bone And Joint Injuries	1 (.12%)
Cardiac Disorder Signs	1 (.12%)
Congenital And Hereditary	1 (.12%)
Dental And Gingival Conditions	1 (.12%)
Disturbances In Thinking	1 (.12%)
Ectoparasitic	1 (.12%)
Gastrointestinal	1 (.12%)
Gastrointestinal Conditions	1 (.12%)
Gastrointestinal Neoplasms Malignan...	1 (.12%)
Hematological	1 (.12%)
Immunology And Allergy	1 (.12%)
Inner Ear And Viiith Cranial Nerve	1 (.12%)
Lipid Analyses	1 (.12%)
Mental Impairment	1 (.12%)
Muscle	1 (.12%)
Musculoskeletal And Connective Tiss...	1 (.12%)
Nephropathies	1 (.12%)
Pregnancy, Labour, Delivery And Pos...	1 (.12%)
Respiratory Disorders Congenital	1 (.12%)

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