LANSOPRAZOLE

Lansoprazole Adverse Events Reported to the FDA Over Time

How are Lansoprazole adverse event reports trending over time?

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

Most Common Lansoprazole Adverse Events Reported to the FDA

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

Pyrexia	233 (1.3%)
Diarrhoea	209 (1.16%)
Drug Ineffective	180 (1%)
Dizziness	179 (1%)
Fatigue	170 (.95%)
Dyspnoea	166 (.92%)
Malaise	160 (.89%)
Paraesthesia	159 (.89%)
Haemoglobin Decreased	154 (.86%)
Cardiac Murmur	152 (.85%)
Melaena	151 (.84%)
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Renal Failure Acute	133 (.74%)
Drug Interaction	128 (.71%)
Rash Maculo-papular	128 (.71%)
Purpura	126 (.7%)
Atrial Fibrillation	125 (.7%)
Rectal Haemorrhage	122 (.68%)
Condition Aggravated	121 (.67%)
Oedema Peripheral	120 (.67%)
Rash Erythematous	116 (.65%)
Rash	111 (.62%)
Interstitial Lung Disease	110 (.61%)
Nausea	110 (.61%)
Feeling Abnormal	109 (.61%)
Vaginal Haemorrhage	109 (.61%)
Colitis Collagenous	106 (.59%)
Ventricular Tachycardia	103 (.57%)
Alanine Aminotransferase Increased	97 (.54%)
Vomiting	94 (.52%)
Toxic Epidermal Necrolysis	93 (.52%)
Sepsis	91 (.51%)
Constipation	90 (.5%)
Liver Disorder	89 (.5%)
Venous Pressure Jugular Increased	84 (.47%)
Weight Decreased	84 (.47%)
Abdominal Pain	82 (.46%)
Arthralgia	81 (.45%)
Oedema	80 (.45%)
Renal Impairment	80 (.45%)
Urinary Tract Infection	80 (.45%)
Drug Exposure During Pregnancy	79 (.44%)
White Blood Cell Count Increased	78 (.43%)
Anaemia	77 (.43%)
Haemorrhage	77 (.43%)
Hypomagnesaemia	77 (.43%)
Left Ventricular Dysfunction	74 (.41%)
Pruritus	74 (.41%)
Agranulocytosis	73 (.41%)
Aspartate Aminotransferase Increase...	73 (.41%)
Rhabdomyolysis	73 (.41%)
Renal Failure	72 (.4%)
Abdominal Pain Upper	71 (.4%)
Convulsion	71 (.4%)
Depressed Level Of Consciousness	70 (.39%)
Confusional State	69 (.38%)
Hepatic Function Abnormal	69 (.38%)
Staphylococcal Infection	69 (.38%)
Drug Rash With Eosinophilia And Sys...	67 (.37%)
Dyspepsia	67 (.37%)
Headache	67 (.37%)
Drug Eruption	66 (.37%)
Hypertension	66 (.37%)
Pneumonia	66 (.37%)
Diabetes Mellitus	64 (.36%)
Dyspnoea Exertional	64 (.36%)
Hiatus Hernia	64 (.36%)
Product Substitution Issue	64 (.36%)
Neutrophil Count Increased	63 (.35%)
Stevens-johnson Syndrome	63 (.35%)
Dehydration	62 (.35%)
Iron Deficiency Anaemia	62 (.35%)
Sinus Tachycardia	62 (.35%)
Erythema Multiforme	61 (.34%)
Gastrooesophageal Reflux Disease	61 (.34%)
Skin Disorder	61 (.34%)
Abdominal Tenderness	59 (.33%)
Blood Alkaline Phosphatase Increase...	59 (.33%)
General Physical Health Deteriorati...	59 (.33%)
Dissociation	58 (.32%)
Erythema	57 (.32%)
Jaundice	57 (.32%)
Thrombocytopenia	57 (.32%)
Disseminated Intravascular Coagulat...	56 (.31%)
Loss Of Consciousness	56 (.31%)
Platelet Count Decreased	56 (.31%)
Asthenia	55 (.31%)
Lower Respiratory Tract Infection	55 (.31%)
Mean Cell Volume Decreased	55 (.31%)
White Blood Cell Count Decreased	54 (.3%)
Body Mass Index Decreased	53 (.3%)
International Normalised Ratio Incr...	53 (.3%)
Monocyte Count Increased	52 (.29%)
Toxic Skin Eruption	52 (.29%)
Anorexia	51 (.28%)
Gastrointestinal Haemorrhage	51 (.28%)
Colitis Microscopic	50 (.28%)
Decreased Appetite	50 (.28%)
Large Intestinal Ulcer	50 (.28%)
Neutropenia	50 (.28%)
Cardiac Failure	48 (.27%)
Hypocalcaemia	48 (.27%)

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

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

Epidermal And Dermal Conditions	1353 (7.53%)
Neurological	786 (4.38%)
Hematology Investigations	770 (4.29%)
Gastrointestinal Signs	657 (3.66%)
Hepatic And Hepatobiliary	547 (3.05%)
Infections - Pathogen Unspecified	540 (3.01%)
Respiratory	506 (2.82%)
Cardiac Arrhythmias	435 (2.42%)
Cardiac And Vascular Investigations	410 (2.28%)
Therapeutic And Nontherapeutic Effe...	388 (2.16%)
Gastrointestinal Motility And Defec...	387 (2.15%)
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Gastrointestinal Hemorrhages	384 (2.14%)
Renal Disorders	371 (2.07%)
Hepatobiliary	331 (1.84%)
Gastrointestinal Inflammatory Condi...	276 (1.54%)
White Blood Cell	260 (1.45%)
Body Temperature Conditions	244 (1.36%)
Anemias Nonhemolytic And Marrow Dep...	239 (1.33%)
Lower Respiratory Tract Disorders	224 (1.25%)
Bacterial Infectious	201 (1.12%)
Electrolyte And Fluid Balance Condi...	198 (1.1%)
Skin Vascular Abnormalities	192 (1.07%)
Physical Examination Topics	178 (.99%)
Gastrointestinal Ulceration And Per...	175 (.97%)
Bone, Calcium, Magnesium And Phosph...	163 (.91%)
Muscle	161 (.9%)
Chemical Injury And Poisoning	137 (.76%)
Appetite And General Nutritional	131 (.73%)
Myocardial	127 (.71%)
Decreased And Nonspecific Blood Pre...	123 (.68%)
Medication Errors	123 (.68%)
Enzyme	120 (.67%)
Renal And Urinary Tract Investigati...	117 (.65%)
Vulvovaginal Disorders	115 (.64%)
Joint	109 (.61%)
Upper Respiratory Tract Disorders	108 (.6%)
Glucose Metabolism Disorders	107 (.6%)
Vision	104 (.58%)
Metabolic, Nutritional And Blood Ga...	96 (.53%)
Seizures	94 (.52%)
Water, Electrolyte And Mineral	94 (.52%)
Heart Failures	93 (.52%)
Platelet	91 (.51%)
Deliria	89 (.5%)
Allergic Conditions	88 (.49%)
Vascular Hemorrhagic	86 (.48%)
Product Quality Issues	84 (.47%)
Oral Soft Tissue Conditions	83 (.46%)
Nephropathies	80 (.45%)
Coronary Artery	79 (.44%)
Protein And Chemistry Analyses	79 (.44%)
Coagulopathies And Bleeding Diathes...	78 (.43%)
Injuries	77 (.43%)
Abdominal Hernias And Other Abdomin...	74 (.41%)
Musculoskeletal And Connective Tiss...	71 (.4%)
Headaches	70 (.39%)
Protein And Amino Acid Metabolism	70 (.39%)
Bronchial Disorders	67 (.37%)
Vascular Hypertensive	66 (.37%)
Sleep Disorders	65 (.36%)
Urinary Tract Signs	65 (.36%)
Procedural And Device Related Injur...	64 (.36%)
Fungal Infectious	61 (.34%)
Cardiac And Vascular Disorders Cong...	60 (.33%)
Gastrointestinal Neoplasms Malignan...	60 (.33%)
Immunology And Allergy	60 (.33%)
Dissociative	58 (.32%)
Tongue Conditions	58 (.32%)
Gastrointestinal Conditions	56 (.31%)
Hematological And Lymphoid Tissue T...	56 (.31%)
Central Nervous System Vascular	55 (.31%)
Disturbances In Thinking	55 (.31%)
Pleural	54 (.3%)
Microbiology And Serology	53 (.3%)
Viral Infectious	53 (.3%)
Movement Disorders	51 (.28%)
Lifestyle Issues	49 (.27%)
Pregnancy, Labour, Delivery And Pos...	47 (.26%)
Skin Appendage Conditions	47 (.26%)
Embolism And Thrombosis	46 (.26%)
Cardiac Disorder Signs	45 (.25%)
Legal Issues	43 (.24%)
Neonatal And Perinatal Conditions	43 (.24%)
Anxiety Disorders	41 (.23%)
Vascular	40 (.22%)
Angiedema And Urticaria	39 (.22%)
Ocular Infections, Irritations And ...	38 (.21%)
Respiratory And Mediastinal Neoplas...	38 (.21%)
Breast	36 (.2%)
Mesotheliomas	36 (.2%)
Acid-base	35 (.19%)
Immune	35 (.19%)
Maternal Complications Of Labour An...	34 (.19%)
Thyroid Gland	34 (.19%)
Gallbladder	32 (.18%)
Mental Impairment	32 (.18%)
Neuromuscular	32 (.18%)
Encephalopathies	31 (.17%)
Inner Ear And Viiith Cranial Nerve	31 (.17%)
Peritoneal And Retroperitoneal Cond...	30 (.17%)
Abortions And Stillbirth	29 (.16%)

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