NEXIUM

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Nexium Adverse Events Reported to the FDA Over Time

How are Nexium adverse event reports trending over time?

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

Most Common Nexium Adverse Events Reported to the FDA

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

Drug Dose Omission	9101 (6.79%)
Gastrooesophageal Reflux Disease	5277 (3.94%)
Malaise	3580 (2.67%)
Drug Ineffective	3280 (2.45%)
Dyspepsia	3000 (2.24%)
Osteoporosis	1951 (1.46%)
Vomiting	1889 (1.41%)
Abdominal Pain Upper	1717 (1.28%)
Pain	1627 (1.21%)
Abdominal Discomfort	1376 (1.03%)
Nausea	1370 (1.02%)
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Intentional Drug Misuse	1323 (.99%)
Multiple Fractures	1321 (.99%)
Off Label Use	1315 (.98%)
Diarrhoea	1156 (.86%)
Chest Pain	1074 (.8%)
Fall	1021 (.76%)
Headache	1013 (.76%)
Dyspnoea	992 (.74%)
Gastric Disorder	903 (.67%)
Insomnia	857 (.64%)
Aphagia	828 (.62%)
Dysphagia	734 (.55%)
Cerebrovascular Accident	722 (.54%)
Cough	720 (.54%)
Diabetes Mellitus	712 (.53%)
Adverse Event	707 (.53%)
Hypertension	694 (.52%)
Throat Irritation	694 (.52%)
Myocardial Infarction	692 (.52%)
Weight Decreased	682 (.51%)
Dizziness	647 (.48%)
Feeling Abnormal	640 (.48%)
Hiatus Hernia	636 (.47%)
Incorrect Dose Administered	626 (.47%)
Abdominal Pain	607 (.45%)
Pneumonia	589 (.44%)
Neoplasm Malignant	581 (.43%)
Depression	573 (.43%)
Fatigue	552 (.41%)
Nasopharyngitis	521 (.39%)
Inappropriate Schedule Of Drug Admi...	504 (.38%)
Anxiety	501 (.37%)
Back Pain	496 (.37%)
Pain In Extremity	479 (.36%)
Ulcer	470 (.35%)
Flatulence	462 (.34%)
Dysphonia	461 (.34%)
Asthma	451 (.34%)
Drug Interaction	443 (.33%)
Arthritis	437 (.33%)
Cardiac Disorder	429 (.32%)
Constipation	427 (.32%)
Abdominal Distension	421 (.31%)
Eructation	419 (.31%)
Arthralgia	416 (.31%)
Regurgitation	409 (.31%)
Asthenia	408 (.3%)
Road Traffic Accident	408 (.3%)
Chronic Obstructive Pulmonary Disea...	389 (.29%)
Oropharyngeal Pain	387 (.29%)
Ill-defined Disorder	375 (.28%)
Muscle Spasms	374 (.28%)
Pyrexia	368 (.27%)
Death	357 (.27%)
Rash	344 (.26%)
Bronchitis	343 (.26%)
Dysgeusia	340 (.25%)
Dry Mouth	337 (.25%)
Memory Impairment	337 (.25%)
Pruritus	335 (.25%)
Condition Aggravated	333 (.25%)
Chest Discomfort	331 (.25%)
Burning Sensation	329 (.25%)
Drug Effect Decreased	326 (.24%)
Wrong Drug Administered	325 (.24%)
Gastritis	319 (.24%)
Oedema Peripheral	307 (.23%)
Anaemia	299 (.22%)
Choking	293 (.22%)
Weight Increased	290 (.22%)
Gait Disturbance	279 (.21%)
Renal Failure Acute	279 (.21%)
Thrombocytopenia	277 (.21%)
Confusional State	275 (.21%)
Blood Cholesterol Increased	269 (.2%)
Oesophageal Disorder	269 (.2%)
Hernia	256 (.19%)
Somnolence	256 (.19%)
Gastric Ulcer	251 (.19%)
Decreased Appetite	244 (.18%)
Myalgia	238 (.18%)
Haemorrhage	235 (.18%)
Renal Failure	235 (.18%)
Upper Limb Fracture	235 (.18%)
Cataract	232 (.17%)
Lower Limb Fracture	232 (.17%)
Palpitations	230 (.17%)
Migraine	228 (.17%)
Osteoarthritis	226 (.17%)
Haematemesis	223 (.17%)

Share/Embed Graph Export Data

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

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

Gastrointestinal Signs	14069 (10.49%)
Medication Errors	11518 (8.59%)
Gastrointestinal Motility And Defec...	7384 (5.51%)
Therapeutic And Nontherapeutic Effe...	5449 (4.06%)
Respiratory	5072 (3.78%)
Bone And Joint Injuries	3951 (2.95%)
Neurological	3507 (2.62%)
Infections - Pathogen Unspecified	3285 (2.45%)
Injuries	2687 (2%)
Bone Disorders	2585 (1.93%)
Epidermal And Dermal Conditions	2363 (1.76%)
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Therapeutic Procedures And Supporti...	1882 (1.4%)
Musculoskeletal And Connective Tiss...	1865 (1.39%)
Gastrointestinal Conditions	1752 (1.31%)
Joint	1652 (1.23%)
Psychiatric	1547 (1.15%)
Sleep Disorders	1523 (1.14%)
Anxiety Disorders	1297 (.97%)
Headaches	1294 (.97%)
Hepatic And Hepatobiliary	1156 (.86%)
Muscle	1148 (.86%)
Central Nervous System Vascular	1093 (.82%)
Physical Examination Topics	1066 (.8%)
Bronchial Disorders	1039 (.78%)
Gastrointestinal Ulceration And Per...	1035 (.77%)
Coronary Artery	1006 (.75%)
Glucose Metabolism Disorders	928 (.69%)
Gastrointestinal Hemorrhages	864 (.64%)
Mental Impairment	832 (.62%)
Renal Disorders	810 (.6%)
Tissue	799 (.6%)
Cardiac Arrhythmias	762 (.57%)
Cardiac And Vascular Investigations	756 (.56%)
Vascular Hypertensive	751 (.56%)
Upper Respiratory Tract Disorders	750 (.56%)
Gastrointestinal Inflammatory Condi...	746 (.56%)
Cardiac Disorder Signs	716 (.53%)
Vision	716 (.53%)
Miscellaneous And Site Unspecified ...	696 (.52%)
Depressed Mood Disorders	684 (.51%)
Abdominal Hernias And Other Abdomin...	671 (.5%)
Electrolyte And Fluid Balance Condi...	669 (.5%)
White Blood Cell	664 (.5%)
Viral Infectious	615 (.46%)
Allergic Conditions	574 (.43%)
Anemias Nonhemolytic And Marrow Dep...	553 (.41%)
Hepatobiliary	530 (.4%)
Lifestyle Issues	520 (.39%)
Bacterial Infectious	515 (.38%)
Movement Disorders	508 (.38%)
Oral Soft Tissue Conditions	505 (.38%)
Urinary Tract Signs	503 (.38%)
Appetite And General Nutritional	490 (.37%)
Musculoskeletal And Connective Tiss...	484 (.36%)
Hematology Investigations	465 (.35%)
Gastrointestinal Neoplasms Malignan...	423 (.32%)
Skin Appendage Conditions	422 (.31%)
Deliria	420 (.31%)
Body Temperature Conditions	410 (.31%)
Lower Respiratory Tract Disorders	400 (.3%)
Fatal Outcomes	392 (.29%)
Salivary Gland Conditions	387 (.29%)
Metabolic, Nutritional And Blood Ga...	373 (.28%)
Hearing	370 (.28%)
Peripheral Neuropathies	363 (.27%)
Lipid Analyses	359 (.27%)
Respiratory And Mediastinal Neoplas...	349 (.26%)
Tongue Conditions	333 (.25%)
Platelet	329 (.25%)
Heart Failures	325 (.24%)
Seizures	325 (.24%)
Bone And Joint Therapeutic Procedur...	320 (.24%)
Procedural And Device Related Injur...	314 (.23%)
Decreased And Nonspecific Blood Pre...	292 (.22%)
Mood Disorders	292 (.22%)
Eye	284 (.21%)
Water, Electrolyte And Mineral	282 (.21%)
Breast Neoplasms Malignant And Unsp...	269 (.2%)
Vascular Hemorrhagic	265 (.2%)
Disturbances In Thinking	260 (.19%)
Bone, Calcium, Magnesium And Phosph...	253 (.19%)
Anterior Eye Structural Change, Dep...	246 (.18%)
Gastrointestinal Therapeutic Proced...	240 (.18%)
Suicidal And Self-injurious Behavio...	234 (.17%)
Inner Ear And Viiith Cranial Nerve	227 (.17%)
Gallbladder	221 (.16%)
Vascular	215 (.16%)
Gastrointestinal Stenosis And Obstr...	207 (.15%)
Exocrine Pancreas Conditions	204 (.15%)
Thyroid Gland	204 (.15%)
Fungal Infectious	199 (.15%)
Vitamin Related	197 (.15%)
Benign Neoplasms Gastrointestinal	193 (.14%)
Embolism And Thrombosis	191 (.14%)
Angiedema And Urticaria	190 (.14%)
Arteriosclerosis, Stenosis, Vascula...	184 (.14%)
Dental And Gingival Conditions	177 (.13%)
Chemical Injury And Poisoning	174 (.13%)
Ocular Infections, Irritations And ...	171 (.13%)
Musculoskeletal And Soft Tissue Inv...	170 (.13%)
Manic And Bipolar Mood Disorders	161 (.12%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Nexium, 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 Nexium 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 Nexium According to Those Reporting Adverse Events

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

Gastrooesophageal Reflux Disease	10568
Drug Use For Unknown Indication	3446
Product Used For Unknown Indication	2701
Dyspepsia	1363
Prophylaxis	818
Gastric Disorder	778
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Gastritis	730
Hiatus Hernia	534
Prophylaxis Against Gastrointestina...	527
Gastric Ulcer	402
Barretts Oesophagus	354
Ulcer	349
Reflux Oesophagitis	318
Abdominal Discomfort	284
Abdominal Pain Upper	280
Oesophagitis	276
Gastrointestinal Disorder	184
Ill-defined Disorder	137
Peptic Ulcer	131
Oesophageal Disorder	124
Erosive Oesophagitis	113
Gastritis Prophylaxis	102
Crohns Disease	98
Helicobacter Infection	97
Hyperchlorhydria	97
Nausea	89
Reflux Gastritis	86
Duodenal Ulcer	84
Gastrointestinal Disorder Therapy	65
Antacid Therapy	60
Flatulence	55
Stomach Discomfort	54
Abdominal Pain	51
Irritable Bowel Syndrome	48
Oesophageal Ulcer	45
Dysphagia	45
Cough	43
Gastrooesophageal Reflux Prophylaxi...	42
Chest Pain	38
Gastric Ph Decreased	38
Vomiting	37
Gastrointestinal Haemorrhage	37
Hernia	33
Gastritis Erosive	32
Impaired Gastric Emptying	30
Eructation	29
Gastroduodenal Ulcer	29
Ulcer Haemorrhage	28
Rheumatoid Arthritis	27
Gastric Ulcer Haemorrhage	26
Reflux Laryngitis	25

Drug Labels

Label	Labeler	Effective
Nexium	A-S Medication Solutions LLC	04-SEP-09
Nexium	STAT RX USA LLC	21-JUL-10
Nexium	Rebel Distributors Corp	03-JAN-11
Nexium	Cardinal Health	18-MAY-11
Nexium	Physicians Total Care, Inc.	04-JAN-12
Nexium	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	04-JAN-12
Nexium	Unit Dose Services	20-JAN-12
Nexiumi.v.	Cardinal Health	10-APR-12
Nexiumi.v.	AstraZeneca LP	09-OCT-12
Nexium	AstraZeneca LP	28-NOV-12
Nexium	Bryant Ranch Prepack	21-JAN-13
Nexium	Bryant Ranch Prepack	21-JAN-13
Nexium	REMEDYREPACK INC.	22-FEB-13
Nexium	Cardinal Health	29-APR-13

Nexium Case Reports

What Nexium 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 Nexium. 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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