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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 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



Possible Nexium side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Multiple Allergies

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

Crestor
    Administration route: Oral

Nexium
    Administration route: Oral

Symbicort



Possible Nexium side effects in 72 year old female

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

Patient: 72 year old female

Reactions: Cataract, Cardiac Disorder

Adverse event resulted in: hospitalization

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

Reactions: Drug Dose Omission, Confusional State, Contusion, Intentional Drug Misuse, Abortion Spontaneous, Fall, Gastritis, Fatigue, Dyspepsia, Balance Disorder, Adverse Event, Gastrooesophageal Reflux Disease, Hiatus Hernia, Drug Effect Decreased, Peptic Ulcer, Maternal Exposure During Pregnancy, Cholelithiasis, Anxiety, Panic Attack, Post-Traumatic Stress Disorder, Neoplasm Malignant, Arthralgia, Joint Swelling, Choking, Inflammation

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

Nexium
    Administration route: Oral



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: Neoplasm Malignant

Drug(s) suspected as cause:
Nexium



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

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