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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 59 year old female

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

Patient: 59 year old female

Reactions: Apparent Death

Adverse event resulted in: life threatening event, hospitalization

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

Symbicort



Possible Nexium side effects in 45 year old female

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

Patient: 45 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Drug Dose Omission, Malaise, Oesophageal Disorder, Gastrooesophageal Sphincter Insufficiency, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium

Other drugs received by patient: Nasal Spray; Allergy Pill; Other Medications



Possible Nexium side effects in female

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

Patient: female

Reactions: Death, Oesophageal Carcinoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in 28 year old female

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

Patient: 28 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Breast Cancer, Drug Ineffective, Nausea, Bone Pain, Headache, Anxiety, Pneumothorax, Depression, Eye Pruritus

Drug(s) suspected as cause:
Neulasta
    Indication: White Blood Cell Count Decreased
    Start date: 2012-07-01

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-07-01

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2002-01-01
    End date: 2012-07-01

Steroid Therapy

Other drugs received by patient: Dexamethasone; Kytril; Promethazine; IV Fluids; Sertraline Hydrochloride; Marinol; Xanax; Singulair; Allegra; Hydrocodone Acetominophen; Fioricet



Possible Nexium side effects in 87 year old female

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

Patient: 87 year old female

Reactions: Renal Failure, Hyponatraemia, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aldactone
    Administration route: Oral
    End date: 2011-12-02

Lasix
    Administration route: Oral
    End date: 2011-12-02

Nexium
    Administration route: Oral
    End date: 2011-12-05

Other drugs received by patient: Bricanyl; Atrovent; Atacand; Previscan



Possible Nexium side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 75 year old male, weighing 92.1 kg (202.6 pounds)

Reactions: Asthma, Dyslipidaemia, Restless Legs Syndrome, Angina Unstable, Intentional Drug Misuse, Constipation, Myocardial Infarction, Cold Sweat, Vomiting, Dyspnoea, Chest Discomfort, Angina Pectoris, Retching, Nausea, Prostate Cancer, Haemorrhoids, Coronary Artery Disease, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Casodex
    Administration route: Oral
    Indication: Prostate Cancer

Lisinopril
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Pulmicort Flexhaler
    Indication: Asthma

Other drugs received by patient: Pravastatin; Pravachol; Tylenol; Clonazepam; Celexa; Nitroglycerin; Colace; Benefiber; Aspirin; Plavix; Naproxen (Aleve); Lopressor; Fibercon; Citalopram Hydrobromide; Ibuprofen



Possible Nexium side effects in 55 year old male

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

Patient: 55 year old male

Reactions: Ligament Rupture, Bone Fragmentation, Dyspnoea, Pain, Joint Injury, Cartilage Injury, Fall, Accident, Malaise

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in female

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

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus Generalised, Vertigo, Fall, Loss of Consciousness, Generalised Oedema

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastric Ulcer
    Start date: 2011-03-18
    End date: 2011-04-20

Nimodipine



Possible Nexium side effects in 58 year old male

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

Patient: 58 year old male

Reactions: Dyspepsia, Drug Ineffective, Accident AT Work, Gastrointestinal Inflammation, Gastric Disorder, Gastrooesophageal Reflux Disease

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

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease



Possible Nexium side effects in 80 year old female

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

Patient: 80 year old female

Reactions: Drug Dose Omission, Phobia, Hypocoagulable State, Throat Irritation, Haemorrhage, Haemoptysis

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in 83 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 83 year old male

Reactions: Drug Dose Omission, Pneumonia, Renal Disorder, Recurrent Cancer, Gastric Disorder, Treatment Noncompliance, Liver Disorder, Pericardial Effusion, Renal Failure, Neoplasm Malignant, Swelling, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor Pills

Nexium
    Administration route: Oral

Toprol-XL
    Administration route: Oral



Possible Nexium side effects in 75 year old male

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

Patient: 75 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Vomiting, Renal Impairment, Nausea, Documented Hypersensitivity To Administered Drug, Aplastic Anaemia, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium

Other drugs received by patient: Plavix; Aspirin



Possible Nexium side effects in 64 year old female

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

Patient: 64 year old female

Reactions: Drug Dose Omission, Functional Gastrointestinal Disorder, Pain, Neck Injury, Chronic Obstructive Pulmonary Disease, Gastric Disorder, Fall, Abdominal Pain Upper, Cardiac Disorder, Foot Fracture, Accident, Diarrhoea, Tibia Fracture, Fibula Fracture, Myocardial Infarction, Back Injury

Drug(s) suspected as cause:
Nexium

Other drugs received by patient: 14 Different Unspecified Medications; Prevacid; Gabapentin; Hydrocodone



Possible Nexium side effects in female

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

Patient: female

Reactions: Confusional State, Acute Pulmonary Oedema, Agitation, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Administration route: Oral

Atorvastatin
    Administration route: Oral

Bisoprolol Fumarate
    Dosage: 2.5 mg in the morning and 1.25 mg in the evening
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Administration route: Oral

Nitroglycerin
    End date: 2012-07-26

Plavix
    Administration route: Oral

Ramipril
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Start date: 2012-07-19
    End date: 2012-07-19



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 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

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