LOSEC

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Losec Adverse Events Reported to the FDA Over Time

How are Losec adverse event reports trending over time?

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

Most Common Losec Adverse Events Reported to the FDA

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

Nausea	22 (2.4%)
Hypomagnesaemia	20 (2.18%)
Vomiting	19 (2.07%)
Asthenia	16 (1.75%)
Diarrhoea	16 (1.75%)
Dizziness	15 (1.64%)
Drug Ineffective	15 (1.64%)
Hypocalcaemia	15 (1.64%)
Dyspnoea	12 (1.31%)
Drug Interaction	11 (1.2%)
Chest Discomfort	10 (1.09%)
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Drug Exposure During Pregnancy	10 (1.09%)
Malaise	10 (1.09%)
Abdominal Pain	9 (.98%)
Dysphagia	9 (.98%)
Allergic Granulomatous Angiitis	8 (.87%)
Cough	8 (.87%)
Hypoparathyroidism	8 (.87%)
Leukocytoclastic Vasculitis	8 (.87%)
Multi-organ Disorder	8 (.87%)
Abortion Spontaneous	7 (.76%)
Cerebrovascular Accident	7 (.76%)
Drug Hypersensitivity	7 (.76%)
Dyspepsia	7 (.76%)
Flatulence	7 (.76%)
Myalgia	7 (.76%)
Pyrexia	7 (.76%)
Constipation	6 (.66%)
Eyelid Oedema	6 (.66%)
Fatigue	6 (.66%)
Haematochezia	6 (.66%)
Hearing Impaired	6 (.66%)
Oedema Peripheral	6 (.66%)
Pruritus	6 (.66%)
Urticaria	6 (.66%)
Chromaturia	5 (.55%)
Depression	5 (.55%)
Gastrooesophageal Reflux Disease	5 (.55%)
Haemorrhage	5 (.55%)
Headache	5 (.55%)
Infection	5 (.55%)
Intestinal Haemorrhage	5 (.55%)
Liver Function Test Abnormal	5 (.55%)
Oesophagitis	5 (.55%)
Retinal Detachment	5 (.55%)
Toxic Epidermal Necrolysis	5 (.55%)
Abdominal Distension	4 (.44%)
Anaphylactic Reaction	4 (.44%)
Blood Creatine Phosphokinase Increa...	4 (.44%)
Blood Gastrin Increased	4 (.44%)
Colitis Collagenous	4 (.44%)
Haematemesis	4 (.44%)
Heart Rate Increased	4 (.44%)
Liver Disorder	4 (.44%)
Muscle Spasms	4 (.44%)
Oesophageal Haemorrhage	4 (.44%)
Overdose	4 (.44%)
Rash	4 (.44%)
Renal Failure	4 (.44%)
Renal Failure Acute	4 (.44%)
Salt Intoxication	4 (.44%)
Throat Tightness	4 (.44%)
Vision Blurred	4 (.44%)
Abdominal Pain Upper	3 (.33%)
Alopecia	3 (.33%)
Anaemia	3 (.33%)
Anaemia Megaloblastic	3 (.33%)
Angioedema	3 (.33%)
Arrhythmia	3 (.33%)
Arthralgia	3 (.33%)
Blindness	3 (.33%)
Blindness Transient	3 (.33%)
Blood Chromogranin A Increased	3 (.33%)
Breast Cancer	3 (.33%)
Cardiac Arrest	3 (.33%)
Choking	3 (.33%)
Cholelithiasis	3 (.33%)
Convulsion	3 (.33%)
Decreased Appetite	3 (.33%)
Device Occlusion	3 (.33%)
Emotional Disorder	3 (.33%)
Eosinophilia	3 (.33%)
Erythema	3 (.33%)
Fall	3 (.33%)
Food Intolerance	3 (.33%)
Gastric Disorder	3 (.33%)
Gastritis	3 (.33%)
Gastrointestinal Haemorrhage	3 (.33%)
Haemolytic Anaemia	3 (.33%)
Hernia	3 (.33%)
Hypernatraemia	3 (.33%)
Hypoaesthesia	3 (.33%)
Hypotension	3 (.33%)
Impaired Gastric Emptying	3 (.33%)
Jaundice	3 (.33%)
Joint Swelling	3 (.33%)
Loss Of Consciousness	3 (.33%)
Neutropenia	3 (.33%)
Off Label Use	3 (.33%)
Paraesthesia	3 (.33%)
Polyuria	3 (.33%)

Share/Embed Graph Export Data

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

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

Gastrointestinal Signs	82 (8.95%)
Respiratory	40 (4.37%)
Bone, Calcium, Magnesium And Phosph...	38 (4.15%)
Neurological	37 (4.04%)
Gastrointestinal Motility And Defec...	32 (3.49%)
Epidermal And Dermal Conditions	31 (3.38%)
Therapeutic And Nontherapeutic Effe...	27 (2.95%)
Gastrointestinal Hemorrhages	25 (2.73%)
Muscle	19 (2.07%)
Gastrointestinal Inflammatory Condi...	17 (1.86%)
Infections - Pathogen Unspecified	16 (1.75%)
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Allergic Conditions	15 (1.64%)
Renal Disorders	15 (1.64%)
Vision	14 (1.53%)
Lower Respiratory Tract Disorders	13 (1.42%)
Medication Errors	12 (1.31%)
Skin Vascular Abnormalities	12 (1.31%)
Anemias Nonhemolytic And Marrow Dep...	11 (1.2%)
Cardiac Arrhythmias	11 (1.2%)
Urinary Tract Signs	11 (1.2%)
Chemical Injury And Poisoning	10 (1.09%)
Electrolyte And Fluid Balance Condi...	10 (1.09%)
Angiedema And Urticaria	9 (.98%)
Decreased And Nonspecific Blood Pre...	9 (.98%)
Hepatobiliary	9 (.98%)
Parathyroid Gland	9 (.98%)
Physical Examination Topics	9 (.98%)
Abortions And Stillbirth	8 (.87%)
Oral Soft Tissue Conditions	8 (.87%)
Appetite And General Nutritional	7 (.76%)
Body Temperature Conditions	7 (.76%)
Cardiac And Vascular Investigations	7 (.76%)
Central Nervous System Vascular	7 (.76%)
Hepatic And Hepatobiliary	7 (.76%)
White Blood Cell	7 (.76%)
Bone And Joint Injuries	6 (.66%)
Hearing	6 (.66%)
Joint	6 (.66%)
Ocular Infections, Irritations And ...	6 (.66%)
Ocular Structural Change, Deposit A...	6 (.66%)
Depressed Mood Disorders	5 (.55%)
Headaches	5 (.55%)
Musculoskeletal And Connective Tiss...	5 (.55%)
Nephropathies	5 (.55%)
Protein And Chemistry Analyses	5 (.55%)
Sleep Disorders	5 (.55%)
Therapeutic Procedures And Supporti...	5 (.55%)
Vascular	5 (.55%)
Vascular Hemorrhagic	5 (.55%)
Endocrine Investigations	4 (.44%)
Enzyme	4 (.44%)
Gallbladder	4 (.44%)
Gastrointestinal Conditions	4 (.44%)
Procedural And Device Related Injur...	4 (.44%)
Seizures	4 (.44%)
Skin Appendage Conditions	4 (.44%)
Tongue Conditions	4 (.44%)
Upper Respiratory Tract Disorders	4 (.44%)
Abdominal Hernias And Other Abdomin...	3 (.33%)
Arteriosclerosis, Stenosis, Vascula...	3 (.33%)
Bacterial Infectious	3 (.33%)
Breast	3 (.33%)
Breast Neoplasms Malignant And Unsp...	3 (.33%)
Deliria	3 (.33%)
Disturbances In Thinking	3 (.33%)
Food Intolerance Syndromes	3 (.33%)
Gastrointestinal Ulceration And Per...	3 (.33%)
Hematology Investigations	3 (.33%)
Hemolyses And Related Conditions	3 (.33%)
Injuries	3 (.33%)
Mood Disorders	3 (.33%)
Breast Therapeutic Procedures	2 (.22%)
Cardiac Disorder Signs	2 (.22%)
Fatal Outcomes	2 (.22%)
Gastrointestinal Therapeutic Proced...	2 (.22%)
Gastrointestinal Tract Disorders Co...	2 (.22%)
Hypothalamus And Pituitary Gland	2 (.22%)
Immune	2 (.22%)
Immunology And Allergy	2 (.22%)
Increased Intracranial Pressure And...	2 (.22%)
Inner Ear And Viiith Cranial Nerve	2 (.22%)
Lifestyle Issues	2 (.22%)
Metabolic, Nutritional And Blood Ga...	2 (.22%)
Nervous System Neoplasms Malignant ...	2 (.22%)
Nervous System, Skull And Spine The...	2 (.22%)
Neuromuscular	2 (.22%)
Obstetric And Gynecological Therape...	2 (.22%)
Ocular Hemorrhages And Vascular	2 (.22%)
Platelet	2 (.22%)
Pleural	2 (.22%)
Pregnancy, Labour, Delivery And Pos...	2 (.22%)
Renal And Urinary Tract Investigati...	2 (.22%)
Respiratory And Mediastinal Neoplas...	2 (.22%)
Respiratory And Pulmonary Investiga...	2 (.22%)
Tissue	2 (.22%)
Vitamin Related	2 (.22%)
Administration Site Reactions	1 (.11%)
Aneurysms And Artery Dissections	1 (.11%)
Anxiety Disorders	1 (.11%)
Benign Neoplasms Gastrointestinal	1 (.11%)
Bone And Joint Therapeutic Procedur...	1 (.11%)

Share/Embed Graph Export Data

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

Common Uses of Losec According to Those Reporting Adverse Events

Why are people taking Losec, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication	130
Gastrooesophageal Reflux Disease	105
Dyspepsia	52
Product Used For Unknown Indication	34
Reflux Oesophagitis	32
Prophylaxis	31
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Oesophagitis	21
Gastritis	17
Prophylaxis Against Gastrointestina...	14
Ulcer	13
Gastric Ulcer	13
Gastric Disorder	11
Gastrointestinal Disorder	9
Barretts Oesophagus	8
Ill-defined Disorder	8
Helicobacter Infection	8
Abdominal Pain Upper	8
Stomach Discomfort	7
Oesophageal Disorder	7
Hiatus Hernia	6
Colitis Ulcerative	5
Hyperchlorhydria	5
Gastritis Atrophic	4
Crohns Disease	4
Gastrooesophageal Reflux Prophylaxi...	4
Peptic Ulcer	4
Retching	3
Irritable Bowel Syndrome	3
Gastritis Prophylaxis	3
Hernia	3
Gastrointestinal Ulcer	2
Vomiting	2
Gastrointestinal Disorder Therapy	2
Abdominal Discomfort	2
Gastrointestinal Ulcer Haemorrhage	2
Vaginal Discharge	2
Gastroduodenitis	2
Pharyngolaryngeal Pain	2
Nausea	2
Duodenal Ulcer	2
Chest Pain	2
Duodenitis	2
Reflux Gastritis	2
Oesophagitis Ulcerative	2
Haematemesis	2
Helicobacter Gastritis	1
Gastrinoma	1
Acute Abdomen	1
Diarrhoea	1
Oesophageal Ulcer	1
Eosinophilic Oesophagitis	1

Losec Case Reports

What Losec safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Losec. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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