OMEPRAZOLE

Omeprazole Adverse Events Reported to the FDA Over Time

How are Omeprazole adverse event reports trending over time?

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

Most Common Omeprazole Adverse Events Reported to the FDA

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

Drug Ineffective	719 (1.85%)
Drug Interaction	527 (1.36%)
Vomiting	505 (1.3%)
Hypomagnesaemia	478 (1.23%)
Diarrhoea	475 (1.23%)
Renal Failure Acute	410 (1.06%)
Gastrooesophageal Reflux Disease	404 (1.04%)
Nausea	367 (.95%)
Hypocalcaemia	335 (.86%)
Malaise	335 (.86%)
Dyspnoea	318 (.82%)
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Pyrexia	300 (.77%)
Dyspepsia	287 (.74%)
Drug Dose Omission	243 (.63%)
Abdominal Pain	242 (.62%)
Condition Aggravated	238 (.61%)
Confusional State	237 (.61%)
Abdominal Pain Upper	224 (.58%)
Hyponatraemia	224 (.58%)
Asthenia	215 (.55%)
Dizziness	206 (.53%)
Agitation	203 (.52%)
Fatigue	197 (.51%)
Headache	196 (.51%)
Toxic Epidermal Necrolysis	193 (.5%)
Fall	191 (.49%)
Pruritus	190 (.49%)
Rash	190 (.49%)
Thrombocytopenia	190 (.49%)
Hypotension	189 (.49%)
Convulsion	187 (.48%)
Weight Decreased	177 (.46%)
Cough	170 (.44%)
Renal Failure	168 (.43%)
Alanine Aminotransferase Increased	167 (.43%)
Decreased Appetite	165 (.43%)
Dehydration	161 (.42%)
Hypertension	161 (.42%)
Rhabdomyolysis	155 (.4%)
Insomnia	153 (.39%)
Hypokalaemia	152 (.39%)
Tubulointerstitial Nephritis	152 (.39%)
Oedema Peripheral	146 (.38%)
Anaemia	141 (.36%)
Anxiety	140 (.36%)
Muscular Weakness	139 (.36%)
Pain	139 (.36%)
Paraesthesia	138 (.36%)
Muscle Spasms	133 (.34%)
Overdose	130 (.34%)
Chest Pain	128 (.33%)
White Blood Cell Count Increased	125 (.32%)
Pneumonia	123 (.32%)
Myalgia	121 (.31%)
Tremor	121 (.31%)
Product Substitution Issue	119 (.31%)
Dysphagia	117 (.3%)
Blood Alkaline Phosphatase Increase...	116 (.3%)
Liver Function Test Abnormal	116 (.3%)
Somnolence	116 (.3%)
Haematemesis	112 (.29%)
Depression	111 (.29%)
Arthralgia	108 (.28%)
Acute Respiratory Distress Syndrome	107 (.28%)
Neutrophil Count Increased	107 (.28%)
Urticaria	107 (.28%)
Completed Suicide	106 (.27%)
Jaundice	106 (.27%)
Cytolytic Hepatitis	105 (.27%)
Neutropenia	105 (.27%)
Loss Of Consciousness	103 (.27%)
Abdominal Discomfort	101 (.26%)
Cholestasis	101 (.26%)
Constipation	101 (.26%)
Sepsis	101 (.26%)
Drug Exposure During Pregnancy	100 (.26%)
General Physical Health Deteriorati...	100 (.26%)
Intentional Drug Misuse	100 (.26%)
Respiratory Failure	100 (.26%)
Gamma-glutamyltransferase Increased	99 (.26%)
Stevens-johnson Syndrome	99 (.26%)
Aspartate Aminotransferase Increase...	98 (.25%)
Drug Effect Decreased	98 (.25%)
Eosinophilia	97 (.25%)
Tachycardia	97 (.25%)
Oropharyngeal Pain	96 (.25%)
Hypersensitivity	94 (.24%)
Cerebrovascular Accident	93 (.24%)
Hyperhidrosis	92 (.24%)
Erythema	91 (.23%)
Interstitial Lung Disease	91 (.23%)
Haemoglobin Decreased	90 (.23%)
Hepatotoxicity	90 (.23%)
Abdominal Distension	87 (.22%)
C-reactive Protein Increased	87 (.22%)
Drug Hypersensitivity	87 (.22%)
Hypoglycaemia	87 (.22%)
Drug Rash With Eosinophilia And Sys...	86 (.22%)
Gastritis	86 (.22%)
Back Pain	84 (.22%)
Death	84 (.22%)

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

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

Gastrointestinal Signs	2224 (5.74%)
Epidermal And Dermal Conditions	2018 (5.21%)
Therapeutic And Nontherapeutic Effe...	1605 (4.14%)
Neurological	1534 (3.96%)
Respiratory	1261 (3.25%)
Hepatic And Hepatobiliary	1065 (2.75%)
Gastrointestinal Motility And Defec...	1024 (2.64%)
Bone, Calcium, Magnesium And Phosph...	934 (2.41%)
Infections - Pathogen Unspecified	852 (2.2%)
Renal Disorders	852 (2.2%)
Hematology Investigations	850 (2.19%)
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Muscle	704 (1.82%)
Electrolyte And Fluid Balance Condi...	686 (1.77%)
Hepatobiliary	672 (1.73%)
Medication Errors	659 (1.7%)
Cardiac Arrhythmias	537 (1.39%)
White Blood Cell	504 (1.3%)
Injuries	475 (1.23%)
Anxiety Disorders	439 (1.13%)
Lower Respiratory Tract Disorders	416 (1.07%)
Deliria	370 (.95%)
Cardiac And Vascular Investigations	367 (.95%)
Bacterial Infectious	360 (.93%)
Body Temperature Conditions	338 (.87%)
Movement Disorders	331 (.85%)
Anemias Nonhemolytic And Marrow Dep...	325 (.84%)
Gastrointestinal Hemorrhages	325 (.84%)
Appetite And General Nutritional	315 (.81%)
Musculoskeletal And Connective Tiss...	307 (.79%)
Physical Examination Topics	304 (.78%)
Sleep Disorders	297 (.77%)
Decreased And Nonspecific Blood Pre...	296 (.76%)
Seizures	288 (.74%)
Allergic Conditions	284 (.73%)
Chemical Injury And Poisoning	279 (.72%)
Central Nervous System Vascular	278 (.72%)
Platelet	271 (.7%)
Urinary Tract Signs	267 (.69%)
Suicidal And Self-injurious Behavio...	236 (.61%)
Headaches	234 (.6%)
Oral Soft Tissue Conditions	229 (.59%)
Skin Appendage Conditions	228 (.59%)
Joint	226 (.58%)
Gastrointestinal Inflammatory Condi...	223 (.58%)
Water, Electrolyte And Mineral	221 (.57%)
Enzyme	220 (.57%)
Nephropathies	214 (.55%)
Metabolic, Nutritional And Blood Ga...	213 (.55%)
Renal And Urinary Tract Investigati...	210 (.54%)
Glucose Metabolism Disorders	199 (.51%)
Vision	196 (.51%)
Product Quality Issues	187 (.48%)
Skin Vascular Abnormalities	181 (.47%)
Bronchial Disorders	180 (.46%)
Vascular Hypertensive	176 (.45%)
Angiedema And Urticaria	173 (.45%)
Gastrointestinal Conditions	168 (.43%)
Depressed Mood Disorders	166 (.43%)
Coronary Artery	165 (.43%)
Disturbances In Thinking	157 (.41%)
Gastrointestinal Ulceration And Per...	151 (.39%)
Psychiatric	150 (.39%)
Mental Impairment	145 (.37%)
Therapeutic Procedures And Supporti...	145 (.37%)
Cardiac Disorder Signs	139 (.36%)
Vascular	135 (.35%)
Bone And Joint Injuries	131 (.34%)
Protein And Chemistry Analyses	130 (.34%)
Fungal Infectious	117 (.3%)
Toxicology And Therapeutic Drug Mon...	114 (.29%)
Upper Respiratory Tract Disorders	112 (.29%)
Viral Infectious	106 (.27%)
Fatal Outcomes	103 (.27%)
Neuromuscular	96 (.25%)
Mood Disorders	92 (.24%)
Cardiac And Vascular Disorders Cong...	91 (.23%)
Exocrine Pancreas Conditions	90 (.23%)
Acid-base	88 (.23%)
Tongue Conditions	86 (.22%)
Tissue	84 (.22%)
Bile Duct	81 (.21%)
Salivary Gland Conditions	80 (.21%)
Myocardial	79 (.2%)
Gastrointestinal Stenosis And Obstr...	78 (.2%)
Bone Disorders	76 (.2%)
Immunology And Allergy	76 (.2%)
Lifestyle Issues	73 (.19%)
Heart Failures	71 (.18%)
Procedural And Device Related Injur...	71 (.18%)
Changes In Physical Activity	68 (.18%)
Vascular Hemorrhagic	68 (.18%)
Eye	67 (.17%)
Hematological And Lymphoid Tissue T...	66 (.17%)
Hemolyses And Related Conditions	66 (.17%)
Personality Disorders	65 (.17%)
Coagulopathies And Bleeding Diathes...	64 (.17%)
Endocrine Investigations	64 (.17%)
Lipid Analyses	64 (.17%)
Respiratory Tract Therapeutic Proce...	64 (.17%)
Schizophrenia And Other Psychotic	63 (.16%)
Dental And Gingival Conditions	61 (.16%)

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