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Nexium (Esomeprazole) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 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 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 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 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



Possible Nexium side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 62 year old female

Reactions: Upper Limb Fracture, Headache, Ankle Fracture, Fall

Drug(s) suspected as cause:
Geodon

Nexium
    Administration route: Oral

Toprol-XL
    Administration route: Oral



Possible Nexium side effects in 49 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 49 year old male, weighing 88.5 kg (194.7 pounds)

Reactions: Off Label Use, Drug Effect Decreased, Dysphagia, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2004-01-01
    End date: 2010-01-01

Omeprazole
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2010-01-01
    End date: 2012-03-01

Omeprazole
    Administration route: Oral

Omeprazole
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-05-01

Other drugs received by patient: Vitamin D; Ropinirole; Propranolol; Savella; Allopurinol; Simvastatin; Clonazapine; Cymbalta; Lamotrigine



Possible Nexium side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 36 year old female

Reactions: Malaise, Oropharyngeal Pain

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in 83 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 83 year old male

Reactions: Diabetes Mellitus, Skin Cancer, Memory Impairment

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Nexium
    Administration route: Oral



Possible Nexium side effects in 58 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 58 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Uterine Cancer, Lung Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium



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

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Atacand
    Administration route: Oral

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral



Possible Nexium side effects in 60 year old male

Reported by a physician from China on 2012-08-27

Patient: 60 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Agitation, Urticaria, Illusion, Duodenal Ulcer, Headache, Aggression, Abnormal Dreams, Irritability, Thinking Abnormal, Oesophageal Discomfort, Mental Disorder, Gastrooesophageal Reflux Disease, Feeling Abnormal

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Start date: 2011-06-13

Omeprazole
    Administration route: Oral
    Indication: Gastric Ulcer
    Start date: 1980-01-01
    End date: 1981-01-01

Omeprazole
    Administration route: Oral
    Start date: 2011-07-01

Omeprazole
    Administration route: Oral
    Start date: 2011-05-01

Omeprazole
    Administration route: Oral
    Start date: 2011-06-01

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