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Nexium (Esomeprazole) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (895)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nexium (Esomeprazole) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 895   Next >>

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 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 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 57 year old female

Reported by a physician from United States on 2012-08-24

Patient: 57 year old female

Reactions: Off Label Use

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

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral
    Indication: Essential Hypertension

Nexium
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Nexium
    Administration route: Oral
    Indication: Type V Hyperlipidaemia

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Essential Hypertension

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Gastrooesophageal Reflux Disease

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Chest Pain

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Type V Hyperlipidaemia

Symbicort
    Dosage: 160/4.5 mcg 2 puffs two times daily
    Indication: Type 2 Diabetes Mellitus



Possible Nexium side effects in 48 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 48 year old male, weighing 113.4 kg (249.5 pounds)

Reactions: Off Label Use, Hypersensitivity, Pain in Extremity, Arthralgia

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Abdominal Distension
    Start date: 2012-02-01

Symbicort
    Dosage: 2 puffs bid
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Singulair; Singulair; Zyrtex OTC; Nasonex



Possible Nexium side effects in 45 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 45 year old female

Reactions: Off Label Use, Bronchitis, Sinusitis, Cough

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

Symbicort
    Dosage: unknown frequency.
    Indication: Cough



Possible Nexium side effects in 74 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 74 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Off Label Use, Vitamin D Decreased, Vertigo, Carotid Artery Occlusion, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-01-01

Nexium
    Administration route: Oral
    Start date: 2011-01-01

Nexium
    Administration route: Oral

Other drugs received by patient: Nifedipine; Propranolol; Levoxyl; Lisinopril



Possible Nexium side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 46 year old female

Reactions: Drug Dose Omission, Burning Sensation, Off Label Use, Aphagia, Dyspnoea

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

Symbicort
    Dosage: dose unknown



Possible Nexium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Off Label Use, Drug Effect Decreased, Throat Irritation

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

Nexium
    Administration route: Oral



Possible Nexium side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 69 year old male, weighing 78.9 kg (173.6 pounds)

Reactions: Drug Dose Omission, Off Label Use, Hiatus Hernia, Cough

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

Symbicort
    Dosage: 160/4.5 mcg, 120 inhalations, bid

Other drugs received by patient: Little White Pill



Possible Nexium side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 62 year old female, weighing 99.8 kg (219.6 pounds)

Reactions: Drug Ineffective, Intentional Drug Misuse, Nasal Congestion, Lower Respiratory Tract Infection, Off Label Use, Adverse Event, Bronchitis, Cough

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

Nexium
    Dosage: twice daily
    Administration route: Oral

Nexium
    Dosage: once daily
    Administration route: Oral

Symbicort
    Dosage: 320 mcg bid
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Vitamin TAB; Crestor; Water Pill



Possible Nexium side effects in 60 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: 60 year old male, weighing 90.7 kg (199.5 pounds)

Reactions: Drug Dose Omission, Pruritus, Diabetes Mellitus, Headache, Cheilitis, Off Label Use, Malaise, Impaired Self-Care, Sedation, Weight Fluctuation, Nervousness, Psychomotor Hyperactivity, Dysphagia, Pain in Extremity, Anaemia, Faecal Incontinence, Diet Noncompliance, Insomnia, Nervous System Disorder, Inappropriate Affect, Somnolence, Constipation, Eructation, Weight Increased, Fatigue, Dyspnoea Exertional, Blood Glucose Fluctuation, Blood Glucose Increased, Dyspnoea, Rhinorrhoea, Pollakiuria, Memory Impairment, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2010-02-08

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Administration route: Oral
    Start date: 2010-04-01

Seroquel
    Administration route: Oral
    Start date: 2010-04-01

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Dosage: taking 300 mg one and 400 mg one at night
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2010-02-08

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Administration route: Oral
    Start date: 2010-04-01

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2010-02-08

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Depression
    Start date: 2010-02-08

Seroquel
    Administration route: Oral
    Start date: 2010-04-01

Seroquel
    Administration route: Oral
    Start date: 2010-04-23

Seroquel
    Dosage: taking 300 mg one and 400 mg one at night
    Administration route: Oral

Seroquel
    Dosage: taking 300 mg one and 400 mg one at night
    Administration route: Oral

Seroquel
    Dosage: taking 300 mg one and 400 mg one at night
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Other drugs received by patient: Fish OIL; Calcium; Topamax; Iron Pills; Levothyroxine Sodium; Wellbutrin XL; Ionpill Ferrous Sulfate; Ativan; Januvia; Lisinopril; Glipizide; Depakote; Glipizide; Butrin; VIT C; Levothyroxine Sodium; Lorazepam; Simvastatin; Lorazepam; Topamax; Gliclazide; EYE Drops; Lumigan; Centrum Ultrum



Possible Nexium side effects in 4 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 4 year old male, weighing 15.9 kg (35.0 pounds)

Reactions: Off Label Use, Flatulence

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral

Other drugs received by patient: Omeprazole; Simethicone



Possible Nexium side effects in 71 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: 71 year old female, weighing 83.9 kg (184.6 pounds)

Reactions: Drug Dose Omission, Emphysema, Abdominal Discomfort, Dermatitis Allergic, Off Label Use, Diarrhoea, Gastric Disorder

Drug(s) suspected as cause:
Nexium
    Dosage: daily
    Administration route: Oral
    Start date: 1992-01-01
    End date: 2002-01-01

Nexium
    Dosage: bid
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2002-01-01

Nexium
    Dosage: dialy
    Administration route: Oral
    Start date: 2002-01-01

Other drugs received by patient: Hydrocodone Bitartrate



Possible Nexium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Bowel Movement Irregularity, Off Label Use, Drug Ineffective

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Start date: 2012-07-01

Nexium
    Administration route: Oral
    Indication: Barrett's Oesophagus
    End date: 2011-01-01

Prilosec
    Administration route: Oral
    Indication: Barrett's Oesophagus
    Start date: 2011-01-01
    End date: 2012-07-01



Possible Nexium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Asthma, Restless Legs Syndrome, Chronic Obstructive Pulmonary Disease, Off Label Use, Neuropathy Peripheral, Oedema Peripheral, Depression, Gastrooesophageal Reflux Disease, Ligament Sprain, Back Pain, Cellulitis, Pneumonia, Haemorrhoids, Anxiety, Hypothyroidism, Essential Hypertension

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

Toprol-XL
    Administration route: Oral

Other drugs received by patient: Vitamin E; Miralax; Bumex; Ativan; Ascorbic Acid; Proventil; Nasonex; Mycostatin; Norco; Levothyroid, Synthroid; Claritin; Aspirin; Exforge; Longs Vitamin D; Advair Diskus 100 / 50; Calcium Carb-D3-MAG Cmb11-Zinc; Ginkgo Biloba



Possible Nexium side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 82 year old female, weighing 81.2 kg (178.6 pounds)

Reactions: Asthma, Drug Dose Omission, Paronychia, Contusion, Gastrointestinal Haemorrhage, Adenomatous Polyposis Coli, Tricuspid Valve Incompetence, Headache, Craniocerebral Injury, Herpes Zoster, Cardiac Disorder, Loss of Consciousness, Off Label Use, Dyspepsia, Adverse Event, Cough, Neuroma, Cervical Dysplasia, Haemorrhagic Anaemia, Paraesthesia, Vulvovaginal Human Papilloma Virus Infection, Back Injury, Aortic Valve Incompetence, Spinal Column Stenosis, Confusional State, Urethral Stenosis, Tendon Rupture, Mental Status Changes, Fall, Groin Pain, Muscle Rupture, Complex Regional Pain Syndrome, Concussion, Chest Pain, Liver Function Test Abnormal, Intervertebral Disc Degeneration, Transient Ischaemic Attack, Myocardial Infarction, Gastrooesophageal Reflux Disease, Dyspnoea, Haemoptysis, Lung Neoplasm, Urinary Tract Infection, Muscular Weakness, Urethral Caruncle, Cystitis, Cerebrovascular Accident, Migraine With Aura, Postoperative Respiratory Distress, Osteoarthritis, Limb Discomfort, Arthralgia, Mitral Valve Incompetence, Urge Incontinence, Flank Pain, Vertigo, Bronchitis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium

Other drugs received by patient: Vicodin; Detrol LA; Vitamin E; Lovaza; Glucosamine Chondroitin; Vitamin D; Soma; Lyrica; Synthroid; Celebrex; K-TAB



Possible Nexium side effects in 62 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-23

Patient: 62 year old male

Reactions: Off Label Use, Chest Pain, Venous Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in 64 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 64 year old male, weighing 61.2 kg (134.6 pounds)

Reactions: Migraine, Weight Decreased, Pain, Drug Intolerance, Hepatic Lesion, Intentional Drug Misuse, Fall, Oral Discomfort, Off Label Use, Sleep Disorder, Dyspepsia, Oesophageal Disorder, Choking, Throat Lesion, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Start date: 2006-10-01

Nexium
    Administration route: Oral
    Start date: 2006-10-01

Nexium
    Administration route: Oral
    Indication: Throat Lesion
    Start date: 2004-10-01
    End date: 2006-10-01

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2004-10-01
    End date: 2006-10-01

Other drugs received by patient: Doxepin; Temazepam; Butalbital



Possible Nexium side effects in 34 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 34 year old male

Reactions: Off Label Use, Neoplasm Malignant, Adverse Event, Gastrooesophageal Reflux Disease

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

Nexium
    Administration route: Oral



Possible Nexium side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 62 year old female

Reactions: Off Label Use, Therapeutic Response Decreased, Nasopharyngitis, DRY Mouth

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

Nexium
    Administration route: Oral

Symbicort
    Dosage: 160/4.5 mcg unknown

Symbicort
    Dosage: 80/4.5 mcg unknown

Other drugs received by patient: Vitamin B Complex CAP



Possible Nexium side effects in 3 month old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 3 month old male, weighing 5.4 kg (11.9 pounds)

Reactions: Off Label Use, Drug Ineffective

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 56 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Hiatus Hernia, Upper-Airway Cough Syndrome, Headache, Intentional Drug Misuse, Off Label Use, Weight Increased, Choking, Feeling Jittery, Fluid Retention, Cough

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

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Symbicort
    Dosage: strength unknown, 2 puffs bid
    Indication: Cough

Other drugs received by patient: Singulair; Claritin; Advil; Mobic; Vitamins and Supplements



Possible Nexium side effects in 87 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 87 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Off Label Use, Osteopetrosis, DRY Mouth

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-01-01

Toprol-XL
    Dosage: daily
    Administration route: Oral
    Indication: Blood Pressure Abnormal

Other drugs received by patient: Hydrochlorothiazide; Blood Pressure Medication



Possible Nexium side effects in 68 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-21

Patient: 68 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Drug Dose Omission, Off Label Use, Hyperchlorhydria

Drug(s) suspected as cause:
Nexium

Other drugs received by patient: High Blood Pressure Medication; Calcium Carbonate



Possible Nexium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Off Label Use, Drug Effect Decreased

Drug(s) suspected as cause:
Metoprolol Tartrate
    Administration route: Oral
    Indication: Blood Pressure

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral
    Indication: Barrett's Oesophagus

Prilosec
    Administration route: Oral

Toprol-XL
    Administration route: Oral
    Indication: Blood Pressure

Other drugs received by patient: Simvastatin; Vitamins OTC



Possible Nexium side effects in 37 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-21

Patient: 37 year old female, weighing 97.5 kg (214.5 pounds)

Reactions: Off Label Use, Maternal Exposure During Pregnancy, Blood Pressure Abnormal

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Off Label Use

Drug(s) suspected as cause:
Nexium



Possible Nexium side effects in 49 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-21

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

Reactions: Off Label Use, Dysphagia, Drug Effect Decreased, 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

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

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

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



Possible Nexium side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Off Label Use, Arthropod Bite

Drug(s) suspected as cause:
Nexium
    Dosage: two times a day
    Administration route: Oral
    Indication: Ulcer
    Start date: 2011-09-08

Omeprazole
    Administration route: Oral



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