PANTOPRAZOLE SODIUM

Pantoprazole Sodium Adverse Events Reported to the FDA Over Time

How are Pantoprazole Sodium adverse event reports trending over time?

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

Most Common Pantoprazole Sodium Adverse Events Reported to the FDA

What are the most common Pantoprazole Sodium adverse events reported to the FDA?

Drug Ineffective	501 (2.11%)
Nausea	352 (1.48%)
Drug Interaction	275 (1.16%)
Vomiting	270 (1.14%)
Malaise	259 (1.09%)
Diarrhoea	251 (1.06%)
Abdominal Pain Upper	212 (.89%)
Gastrooesophageal Reflux Disease	208 (.88%)
Death	196 (.83%)
Pruritus	193 (.81%)
Dyspnoea	190 (.8%)
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Headache	186 (.78%)
Condition Aggravated	182 (.77%)
Dizziness	182 (.77%)
Rash	167 (.7%)
Renal Failure Acute	160 (.67%)
Cerebrovascular Accident	152 (.64%)
Fatigue	152 (.64%)
Pyrexia	144 (.61%)
Dyspepsia	141 (.59%)
Pain	141 (.59%)
Weight Decreased	141 (.59%)
Asthenia	137 (.58%)
Hypertension	137 (.58%)
Thrombocytopenia	133 (.56%)
Fall	128 (.54%)
Chest Pain	125 (.53%)
Confusional State	125 (.53%)
Hyponatraemia	124 (.52%)
Abdominal Pain	123 (.52%)
Suicide Attempt	120 (.51%)
Anaemia	118 (.5%)
Drug Screen Positive	116 (.49%)
Arthralgia	113 (.48%)
Renal Failure	111 (.47%)
Myocardial Infarction	103 (.43%)
Drug Screen False Positive	102 (.43%)
Alanine Aminotransferase Increased	97 (.41%)
Toxic Epidermal Necrolysis	96 (.4%)
Flatulence	94 (.4%)
General Physical Health Deteriorati...	91 (.38%)
Hypersensitivity	88 (.37%)
Somnolence	87 (.37%)
Agranulocytosis	86 (.36%)
Anxiety	86 (.36%)
Constipation	86 (.36%)
Depression	86 (.36%)
Hypomagnesaemia	86 (.36%)
Abdominal Distension	83 (.35%)
Oedema Peripheral	83 (.35%)
Aspartate Aminotransferase Increase...	82 (.35%)
Drug Rash With Eosinophilia And Sys...	79 (.33%)
Leukopenia	79 (.33%)
Back Pain	77 (.32%)
Gastric Disorder	77 (.32%)
Insomnia	75 (.32%)
Abdominal Discomfort	74 (.31%)
Myalgia	74 (.31%)
Neutropenia	74 (.31%)
Blood Cholesterol Increased	73 (.31%)
Jaundice	73 (.31%)
Product Substitution Issue	72 (.3%)
Stevens-johnson Syndrome	72 (.3%)
Drug Effect Decreased	71 (.3%)
Feeling Abnormal	71 (.3%)
Convulsion	70 (.29%)
Cough	70 (.29%)
Haemoglobin Decreased	70 (.29%)
Hypocalcaemia	70 (.29%)
Hypotension	70 (.29%)
Pain In Extremity	70 (.29%)
Chest Discomfort	68 (.29%)
Loss Of Consciousness	68 (.29%)
Muscle Spasms	66 (.28%)
Tremor	65 (.27%)
Cholestasis	64 (.27%)
Dehydration	64 (.27%)
Dry Mouth	64 (.27%)
Heart Rate Increased	63 (.27%)
Urticaria	63 (.27%)
Completed Suicide	62 (.26%)
Burning Sensation	59 (.25%)
Diabetes Mellitus	59 (.25%)
Rash Maculo-papular	59 (.25%)
Cardiac Disorder	58 (.24%)
Decreased Appetite	58 (.24%)
Erythema	58 (.24%)
Gamma-glutamyltransferase Increased	58 (.24%)
Hyperhidrosis	58 (.24%)
Cytolytic Hepatitis	57 (.24%)
Pancreatitis	57 (.24%)
Vision Blurred	57 (.24%)
Pancytopenia	56 (.24%)
Paraesthesia	56 (.24%)
Toxic Skin Eruption	56 (.24%)
Vertigo	56 (.24%)
Blood Alkaline Phosphatase Increase...	55 (.23%)
Eosinophilia	55 (.23%)
Rash Erythematous	55 (.23%)
Chills	53 (.22%)
Hypokalaemia	53 (.22%)

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

What are the most common Pantoprazole Sodium adverse events reported to the FDA?

Gastrointestinal Signs	1582 (6.66%)
Epidermal And Dermal Conditions	1420 (5.98%)
Therapeutic And Nontherapeutic Effe...	982 (4.14%)
Neurological	928 (3.91%)
Hepatic And Hepatobiliary	647 (2.73%)
Respiratory	629 (2.65%)
Gastrointestinal Motility And Defec...	623 (2.62%)
Cardiac Arrhythmias	424 (1.79%)
Infections - Pathogen Unspecified	402 (1.69%)
Hepatobiliary	376 (1.58%)
Hematology Investigations	360 (1.52%)
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Renal Disorders	346 (1.46%)
White Blood Cell	333 (1.4%)
Medication Errors	324 (1.36%)
Electrolyte And Fluid Balance Condi...	284 (1.2%)
Toxicology And Therapeutic Drug Mon...	277 (1.17%)
Musculoskeletal And Connective Tiss...	273 (1.15%)
Central Nervous System Vascular	270 (1.14%)
Muscle	267 (1.12%)
Bacterial Infectious	263 (1.11%)
Injuries	261 (1.1%)
Anemias Nonhemolytic And Marrow Dep...	229 (.96%)
Cardiac And Vascular Investigations	229 (.96%)
Suicidal And Self-injurious Behavio...	217 (.91%)
Physical Examination Topics	216 (.91%)
Fatal Outcomes	215 (.91%)
Allergic Conditions	211 (.89%)
Headaches	211 (.89%)
Joint	211 (.89%)
Bone, Calcium, Magnesium And Phosph...	193 (.81%)
Coronary Artery	190 (.8%)
Deliria	188 (.79%)
Anxiety Disorders	182 (.77%)
Gastrointestinal Conditions	170 (.72%)
Oral Soft Tissue Conditions	165 (.7%)
Gastrointestinal Hemorrhages	160 (.67%)
Platelet	159 (.67%)
Vision	157 (.66%)
Body Temperature Conditions	155 (.65%)
Vascular Hypertensive	150 (.63%)
Product Quality Issues	145 (.61%)
Urinary Tract Signs	144 (.61%)
Movement Disorders	143 (.6%)
Gastrointestinal Inflammatory Condi...	137 (.58%)
Decreased And Nonspecific Blood Pre...	136 (.57%)
Exocrine Pancreas Conditions	127 (.54%)
Cardiac Disorder Signs	123 (.52%)
Metabolic, Nutritional And Blood Ga...	122 (.51%)
Bone And Joint Injuries	116 (.49%)
Therapeutic Procedures And Supporti...	114 (.48%)
Seizures	113 (.48%)
Appetite And General Nutritional	111 (.47%)
Depressed Mood Disorders	111 (.47%)
Lower Respiratory Tract Disorders	110 (.46%)
Mental Impairment	110 (.46%)
Bone Disorders	109 (.46%)
Enzyme	108 (.45%)
Gastrointestinal Ulceration And Per...	108 (.45%)
Sleep Disorders	108 (.45%)
Lipid Analyses	107 (.45%)
Angiedema And Urticaria	104 (.44%)
Water, Electrolyte And Mineral	103 (.43%)
Glucose Metabolism Disorders	101 (.43%)
Upper Respiratory Tract Disorders	99 (.42%)
Disturbances In Thinking	98 (.41%)
Skin Appendage Conditions	94 (.4%)
Salivary Gland Conditions	90 (.38%)
Bronchial Disorders	87 (.37%)
Inner Ear And Viiith Cranial Nerve	86 (.36%)
Tongue Conditions	86 (.36%)
Chemical Injury And Poisoning	84 (.35%)
Psychiatric	83 (.35%)
Lifestyle Issues	79 (.33%)
Embolism And Thrombosis	78 (.33%)
Heart Failures	73 (.31%)
Renal And Urinary Tract Investigati...	73 (.31%)
Nephropathies	72 (.3%)
Protein And Chemistry Analyses	72 (.3%)
Administration Site Reactions	71 (.3%)
Immunology And Allergy	68 (.29%)
Viral Infectious	65 (.27%)
Skin Vascular Abnormalities	64 (.27%)
Tissue	64 (.27%)
Vascular	57 (.24%)
Procedural And Device Related Injur...	52 (.22%)
Vascular Hemorrhagic	51 (.21%)
Gallbladder	50 (.21%)
Malabsorption Conditions	47 (.2%)
Gastrointestinal Neoplasms Malignan...	46 (.19%)
Eye	43 (.18%)
Arteriosclerosis, Stenosis, Vascula...	41 (.17%)
Miscellaneous And Site Unspecified ...	41 (.17%)
Microbiology And Serology	40 (.17%)
Aneurysms And Artery Dissections	37 (.16%)
Dental And Gingival Conditions	37 (.16%)
Eating Disorders	37 (.16%)
Gastrointestinal Stenosis And Obstr...	37 (.16%)
Fungal Infectious	36 (.15%)
Gastrointestinal Vascular Condition...	36 (.15%)
Pleural	36 (.15%)
Mood Disorders	35 (.15%)

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