This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nexium (Esomeprazole) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (16601)
Death (295)
Life Threatening Events (201)
Disability (162)
Reports by Reaction Type
Drug Dose Omission (5400),
Gastrooesophageal Reflux Disease (3182),
Malaise (2313),
Osteoporosis (1667),
Dyspepsia (1661),
Drug Ineffective (1621),
Multiple Fractures (1284),
Intentional Drug Misuse (1063),
Pain (986),
Vomiting (973),
Off Label Use (895),
Abdominal Pain Upper (779)
Below are a few examples of reports where side effects / adverse reactions may be related to Nexium (Esomeprazole). For a complete list or a specific selection of reports, please use the links above.
Possible Nexium side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 71 year old female
Reactions: Diabetes Mellitus, Drug Ineffective
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Prilosec
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Other drugs received by patient: Dexilant
Possible Nexium side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 50 year old female
Reactions: Drug Dose Omission, Migraine, Viral Infection, Nausea, Haemoptysis, Malaise, Memory Impairment, Blood Pressure Abnormal, Gastroenteritis Viral
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Zomig
Administration route: Oral
Indication: Cluster Headache
Zomig
Administration route: Oral
Indication: Migraine
Possible Nexium side effects in 78 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 78 year old female
Reactions: Cataract, Contusion, Sternal Fracture, Drug Intolerance, Device Expulsion, Road Traffic Accident, Limb Injury, Middle Ear Disorder, Chronic Sinusitis, Renal Failure Acute, Infection
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Prilosec
Administration route: Oral
Start date: 1999-01-01
Other drugs received by patient: EAR Drops; Zithromax
Possible Nexium side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Gastrointestinal Haemorrhage, Mouth Haemorrhage, Adverse Event
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 67 year old female
Reactions: Breast Cancer, Lower Limb Fracture
Drug(s) suspected as cause:
Anastrozole
Administration route: Oral
Crestor
Administration route: Oral
Nexium
Administration route: Oral
Possible Nexium side effects in 57 year old male
Reported by a consumer/non-health professional from China on 2012-08-27
Patient: 57 year old male, weighing 50.0 kg (110.0 pounds)
Reactions: Haemangioma of Liver, Blood Disorder, Gastric Polyps, Thyroid Neoplasm, Splenic Cyst
Drug(s) suspected as cause:
Nexium
Administration route: Oral
End date: 2010-10-01
Nexium
Administration route: Oral
Indication: Gastric Ulcer
Start date: 2010-04-01
End date: 2010-10-01
Other drugs received by patient: Antibiotics
Possible Nexium side effects in 44 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 44 year old male
Reactions: Accident, Mucosal Ulceration, Bipolar Disorder, Spinal Fracture, Dementia Alzheimer's Type, Adverse Event, Fall, Prostatic Disorder, RIB Fracture
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Seroquel XR
Administration route: Oral
Other drugs received by patient: Levaquin; Armodafinil; Zithromax
Possible Nexium side effects in 82 year old female
Reported by a individual with unspecified qualification from United States on 2012-08-27
Patient: 82 year old female, weighing 118.8 kg (261.4 pounds)
Reactions: Drug Dose Omission, Contusion, Haemoptysis, Head Injury, Drug Ineffective, Sensation of Heaviness, Fall, Oesophageal Stenosis, Body Height Decreased, Chest Pain, Peripheral Nerve Lesion, Bone Disorder, Gastrooesophageal Reflux Disease, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2010-01-01
End date: 2012-05-01
Omeprazole
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2012-05-01
Other drugs received by patient: Anonox; Xanax; D3; Ditropan; Dexilant; Lovaza; Preservesion
Possible Nexium side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 48 year old female
Reactions: Urinary Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Toprol-XL
Administration route: Oral
Possible Nexium side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 50 year old female
Reactions: Drug Dose Omission, Burning Sensation, Abdominal Pain Upper
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 81 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 81 year old male
Reactions: Osteoarthritis, Bone Loss, Spinal Fracture, Malnutrition, Erosive Oesophagitis, Pathological Fracture, Gastrointestinal Mucosal Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 47 year old male
Reported by a physician from France on 2012-08-27
Patient: 47 year old male
Reactions: Respiratory Tract Infection Bacterial, Epstein-Barr Virus Associated Lymphoma, Congestive Cardiomyopathy, Systolic Dysfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Start date: 2012-06-08
Doxorubicin HCL
Start date: 2012-06-11
End date: 2012-07-10
Mabthera
Start date: 2012-06-11
Nexium
Administration route: Oral
Prednisolone
Administration route: Oral
Start date: 2012-06-08
Vincristine
Start date: 2012-06-08
Other drugs received by patient: Previscan; Methotrexate Sodium; Potassium Chloride; Kineret; Kineret; Kineret; Cacit D3; Aspirin; Prednisone TAB; Acetaminophen; Acetaminophen W / Codeine; Alendronate Sodium / Cholecalciferol
Possible Nexium side effects in 69 year old female
Reported by a physician from Japan on 2012-08-27
Patient: 69 year old female, weighing 42.0 kg (92.4 pounds)
Reactions: Hyperlipidaemia, Subclavian Artery Stenosis, Gastrointestinal Inflammation, Hypoalbuminaemia, Intracranial Aneurysm, Hypertension
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2012-06-16
End date: 2012-07-01
Omeprazole
Administration route: Oral
Start date: 2007-06-27
End date: 2007-10-21
Omeprazole
Administration route: Oral
Start date: 2007-10-22
End date: 2010-11-16
Omeprazole
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2004-04-28
Omeprazole
Dosage: omeprazon, 10 mg daily
Start date: 2005-08-04
End date: 2007-06-26
Other drugs received by patient: Miya BM; Crestor; Warfarin Sodium; Micardis; Pancreaze; Amoxicillin; Clarithromycin; Amlodipine Besylate; Zetia; Pletal; Protecadin
Possible Nexium side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 79 year old female
Reactions: Pancreatic Disorder, Drug Dose Omission, Malaise, Blood Cholesterol Increased, Intentional Drug Misuse, Gastrooesophageal Reflux Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Nexium
Administration route: Oral
Other drugs received by patient: Pancreas Medication
Possible Nexium side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 48 year old female
Reactions: Drug Dose Omission, Hereditary Haemorrhagic Telangiectasia, Epistaxis
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 54 year old male
Reactions: Drug Dose Omission, Vomiting, Malaise, Hernia, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Nexium
Other drugs received by patient: Zantac; Calcium Carbonate; Prevacid
Possible Nexium side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: 61 year old female
Reactions: Agitation, Confusional State, Acute Pulmonary Oedema, Metastatic Pain, Hypercalcaemia, Renal Failure Acute
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Acetaminophen
Dosage: 1 g, 1x/day
Administration route: Oral
End date: 2012-07-26
Aspirin
Dosage: 75 mg, 1x/day
Administration route: Oral
Atorvastatin
Dosage: 10 mg, 1x/day
Administration route: Oral
Bisoprolol Fumarate
Dosage: 3.75 mg, 1x/day
Administration route: Oral
End date: 2012-07-27
Cymbalta
Dosage: 60 mg, 1x/day
Administration route: Oral
End date: 2012-07-26
Duragesic-100
Dosage: 50 mg, 1x/day
End date: 2012-07-26
Lercanidipine
Dosage: 10 mg, 1x/day
Administration route: Oral
End date: 2012-07-26
Lyrica
Dosage: 75 mg, 2x/day
Administration route: Oral
End date: 2012-07-26
Nexium
Dosage: 20 mg, 1x/day
Administration route: Oral
Nitroglycerin
Dosage: 5 mg, 1x/day
End date: 2012-07-26
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Ramipril
Dosage: 10 mg, 1x/day
Administration route: Oral
End date: 2012-07-26
Zometa
Dosage: 4 mg, single
Indication: Hypercalcaemia
Start date: 2012-07-19
End date: 2012-07-19
Possible Nexium side effects in 58 year old female
Reported by a individual with unspecified qualification from United States on 2012-08-27
Patient: 58 year old female
Reactions: Road Traffic Accident, Upper Limb Fracture
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 50 year old female
Reactions: Cerebrovascular Accident
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 71 year old male
Reported by a individual with unspecified qualification from United States on 2012-08-27
Patient: 71 year old male, weighing 90.7 kg (199.5 pounds)
Reactions: Off Label Use, Prostate Cancer, Gout, Drug Ineffective
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2007-01-01
End date: 2011-01-01
Nexium
Administration route: Oral
Start date: 2011-01-01
Nexium
Administration route: Oral
Indication: Dyspepsia
Start date: 2007-01-01
End date: 2011-01-01
Nexium
Administration route: Oral
Start date: 2011-01-01
Other drugs received by patient: Allopurinol; Indocin; Lipitor; Flomax
Possible Nexium side effects in 60 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: 60 year old female
Reactions: Gallbladder Disorder, Blood Pressure Abnormal, Laryngeal Oedema, Vocal Cord Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nexium
Other drugs received by patient: Calcium
Possible Nexium side effects in 82 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 82 year old female
Reactions: Hiatus Hernia, Ulcer
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Nexium
Administration route: Oral
Possible Nexium side effects in 68 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 68 year old male, weighing 68.9 kg (151.6 pounds)
Reactions: Drug Dose Omission, Oesophagitis, Drug Ineffective, Dysphonia, Choking, Gastrooesophageal Reflux Disease, Precancerous Cells Present
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Barrett's Oesophagus
Nexium
Administration route: Oral
Prilosec
Administration route: Oral
Other drugs received by patient: Aspirin; Tetracycline; Proscar
Possible Nexium side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 66 year old female
Reactions: Drug Dose Omission, Malaise, Bladder Cancer
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 67 year old female
Reactions: Intracranial Aneurysm, Intentional Drug Misuse, Erosive Oesophagitis, Amnesia
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 68 year old female, weighing 101.0 kg (222.2 pounds)
Reactions: Drug Dose Omission, Vomiting, Pain in Extremity, Drug Ineffective, Chest Pain, Bladder Disorder, DRY Skin, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Nexium
Other drugs received by patient: Amlodipine; Paxil; Clobetasol Propionate
Possible Nexium side effects in 48 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 48 year old male
Reactions: Regurgitation, Drug Dose Omission, Drug Ineffective, Constipation, Off Label Use, Malaise, Impaired Self-Care, Gastrooesophageal Reflux Disease, Decreased Appetite, Stress, Gastric Disorder, Gastric Haemorrhage, Staphylococcal Infection, Bipolar Disorder, Sinus Disorder, Insomnia, Attention Deficit / Hyperactivity Disorder, Depressed Mood, Ulcer Haemorrhage
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Prilosec
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Bipolar I Disorder
Seroquel
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Bipolar Disorder
Seroquel
Administration route: Oral
Other drugs received by patient: Prevacid; Xanax; Adderall 10
Possible Nexium side effects in male
Reported by a physician from Brazil on 2012-08-27
Patient: male
Reactions: Death, Oesophageal Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Nexium
Possible Nexium side effects in 81 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 81 year old male
Reactions: Asthma, Drug Dose Omission, Nasopharyngitis, Dyspnoea, Prostate Cancer, Haemoptysis, Chronic Obstructive Pulmonary Disease, Abdominal Discomfort, Malaise, DRY Mouth, Disturbance in Attention, Hypertension, Myocardial Infarction
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Nexium
Administration route: Oral
Symbicort
Dosage: 80/4.5 mcg two puffs two times a day
Toprol-XL
Administration route: Oral
Possible Nexium side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: 61 year old female
Reactions: Confusional State, Agitation, Renal Failure Acute
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Acetaminophen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-26
Aspirin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Atorvastatin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Bisoprolol Fumarate
Dosage: 2.5-0-1.25
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-27
Cymbalta
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-26
Duragesic-100
Indication: Product Used FOR Unknown Indication
End date: 2012-07-26
Lercanidipine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-26
Lyrica
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-26
Nexium
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Nitroglycerin
Indication: Product Used FOR Unknown Indication
End date: 2012-07-27
Plavix
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ramipril
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-07-26
Zometa
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-19
End date: 2012-07-19
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