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Prilosec (Omeprazole) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (133)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prilosec (Omeprazole) 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 133   Next >>

Possible Prilosec 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 Prilosec 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 Prilosec side effects in 55 year old female

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

Patient: 55 year old female, weighing 49.4 kg (108.7 pounds)

Reactions: Nasopharyngitis, Diabetes Mellitus, Chills, Headache, Off Label Use, Fatigue, Chest Pain, Cough, Cardiac Failure Congestive, Abdominal Pain Lower, Back Pain, Vomiting, Nausea, Musculoskeletal Pain, Immune System Disorder, Gait Disturbance

Drug(s) suspected as cause:
Lisinopril
    Administration route: Oral
    Indication: Hypertension

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2000-10-28

Symbicort
    Dosage: 1 df bid
    Start date: 2012-03-01

Symbicort
    Dosage: 1 df bid
    Start date: 2012-03-01

Symbicort
    Dosage: 1 df bid
    Indication: Asthma
    Start date: 2012-02-24

Symbicort
    Dosage: 1 df bid
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-02-24

Other drugs received by patient: Fluticasone Propionate; Combivent; Sodium Chloride 0.9%; Lasix; Ranitidine; Zocor



Possible Prilosec side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 26 year old female

Reactions: Off Label Use, Vomiting, Maternal Exposure During Pregnancy, Headache, Nerve Compression

Adverse event resulted in: hospitalization

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

Prilosec OTC
    Dosage: once or twice daily
    Administration route: Oral
    Indication: Dyspepsia

Other drugs received by patient: Multi-Vitamins; Butalbital Acetaminophen Caffeine; Phenergan HCL



Possible Prilosec 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 Prilosec side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 72 year old female, weighing 81.6 kg (179.5 pounds)

Reactions: Drug Dose Omission, Off Label Use, Drug Ineffective, Oedema Peripheral, Gastric Disorder

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

Prilosec
    Administration route: Oral

Prilosec
    Dosage: generic
    Administration route: Oral

Prilosec OTC
    Administration route: Oral



Possible Prilosec side effects in 85 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: 85 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Off Label Use, Drug Dose Omission, Oesophageal Pain, Drug Ineffective, Pain, Oesophageal Disorder, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-01-01
    End date: 2012-05-01

Nexium
    Administration route: Oral
    Start date: 2012-07-01

Nexium
    Administration route: Oral
    Start date: 2012-07-01

Nexium
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2008-01-01
    End date: 2012-05-01

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-05-01
    End date: 2012-07-01

Other drugs received by patient: Plavix; Januvia; Zantac; Glyburide; Diovan



Possible Prilosec side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 64 year old male

Reactions: Drug Dose Omission, Circumstance or Information Capable of Leading To Medication Error, Drug Ineffective, Dementia, Pain, Condition Aggravated, Delirium, Cardiac Disorder, Off Label Use, Choking, Adverse Event, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

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

Nexium
    Administration route: Oral
    Indication: Hiatus Hernia

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Barrett's Oesophagus

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral

Other drugs received by patient: Prevacid



Possible Prilosec side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Off Label Use, Vomiting, Maternal Exposure During Pregnancy, Headache, Nerve Compression

Adverse event resulted in: hospitalization

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

Prilosec OTC
    Dosage: once or twice daily
    Administration route: Oral
    Indication: Dyspepsia

Other drugs received by patient: Phenergan HCL; Butalbital Acetaminophen Caffeine; Multi-Vitamins



Possible Prilosec side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

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 Prilosec side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 64 year old male

Reactions: Drug Ineffective, Circumstance or Information Capable of Leading To Medication Error, Dementia, Condition Aggravated, Delirium, Cardiac Disorder, Off Label Use, Choking, Adverse Event, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

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

Nexium
    Administration route: Oral
    Indication: Hiatus Hernia

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Barrett's Oesophagus

Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral

Other drugs received by patient: Prevacid



Possible Prilosec side effects in 9 month old female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 9 month old female

Reactions: Off Label Use, Drug Ineffective

Drug(s) suspected as cause:
Prilosec



Possible Prilosec side effects in 3 month old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 3 month old female, weighing 13.0 kg (28.6 pounds)

Reactions: Off Label Use, Ear Infection

Drug(s) suspected as cause:
Prilosec
    Administration route: Oral
    Start date: 2011-12-01

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-06-01
    End date: 2011-12-01



Possible Prilosec side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 33 year old female, weighing 101.6 kg (223.5 pounds)

Reactions: Drug Dose Omission, Off Label Use, Drug Ineffective

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

Nexium
    Administration route: Oral
    Indication: Dyspepsia

Prilosec
    Administration route: Oral



Possible Prilosec side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 56 year old female

Reactions: Regurgitation, Nasopharyngitis, Drug Ineffective, Intentional Drug Misuse, Oropharyngeal Pain, Off Label Use, Lung Disorder, Malaise, Choking, Immune System Disorder

Drug(s) suspected as cause:
Nexium
    Dosage: 30 mg
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Dosage: 30 mg
    Administration route: Oral
    Indication: Dyspepsia

Prilosec
    Administration route: Oral

Other drugs received by patient: Cancer Pills



Possible Prilosec side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 61 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Off Label Use, Drug Ineffective, Condition Aggravated, Intentional Drug Misuse

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2007-01-01

Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Vitamin B-12; Meclizine; Premarin; Zoloft; Urostat; Calcium Carbonate; Cardiazem; Prinivil; Tekturna; Ativan; Lipitor; Vitamin D



Possible Prilosec side effects in 61 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-13

Patient: 61 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Gingivitis, Eye Irritation, Gingival Disorder, Iron Deficiency, Intentional Drug Misuse, Headache, Nasal Congestion, Off Label Use, Visual Impairment, Vision Blurred, Sneezing, Sinusitis

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

Prilosec OTC
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Rhinocort
    Dosage: 2 sprays daily
    Start date: 2012-03-13
    End date: 2012-03-26

Rhinocort
    Dosage: 32 mcg 120 meter spray/unit
    Indication: Seasonal Allergy

Rhinocort
    Dosage: 32 mcg 120 meter spray/unit
    Indication: Sinus Disorder

Rhinocort
    Dosage: 2 puffs, prn

Rhinocort
    Dosage: 2 puffs, prn

Rhinocort
    Dosage: 2 sprays daily
    Start date: 2012-03-13
    End date: 2012-03-26

Rhinocort
    Dosage: 32 mcg 120 meter spray/unit
    Indication: Rhinitis Seasonal

Rhinocort
    Dosage: 2 puffs, prn

Rhinocort
    Dosage: 2 sprays daily
    Start date: 2012-03-13
    End date: 2012-03-26

Other drugs received by patient: Rolaids; Anacin; Antibiotics



Possible Prilosec side effects in 40 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-10

Patient: 40 year old male, weighing 105.2 kg (231.4 pounds)

Reactions: Off Label Use, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Prilosec
    Dosage: 40 mg twice a day
    Administration route: Oral
    Start date: 2012-06-01

Prilosec
    Dosage: 20 mg twice a day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-03-01
    End date: 2012-06-01

Other drugs received by patient: Depression Medication; Zantac



Possible Prilosec side effects in 48 year old male

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

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, Gastric Haemorrhage, Stress, Gastric Disorder, Bipolar Disorder, Staphylococcal Infection, Sinus Disorder, Insomnia, Ulcer Haemorrhage, Depressed Mood, Attention Deficit / Hyperactivity Disorder

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

Prilosec
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

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

Other drugs received by patient: Adderall 10; Xanax



Possible Prilosec side effects in female

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

Patient: female

Reactions: Off Label Use, Dyspepsia, Drug Ineffective, Abdominal Pain Upper

Drug(s) suspected as cause:
Prilosec
    Administration route: Oral
    Indication: Abdominal Pain Upper

Prilosec
    Administration route: Oral
    Indication: Dyspepsia



Possible Prilosec side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Off Label Use, Drug Ineffective

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

Prilosec
    Administration route: Oral



Possible Prilosec side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-05

Patient:

Reactions: Off Label Use, Renal Disorder

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

Prilosec
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Zetia



Possible Prilosec side effects in 80 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-03

Patient: 80 year old female

Reactions: Off Label Use, Drug Dose Omission, Barrett's Oesophagus, Drug Ineffective, Nausea, Sleep Disorder DUE To General Medical Condition, Insomnia Type, Herpes Ophthalmic, Gastrooesophageal Reflux Disease, Herpes Zoster

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

Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral

Prilosec OTC
    Administration route: Oral

Other drugs received by patient: Klor-CON



Possible Prilosec side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 64 year old female, weighing 65.8 kg (144.8 pounds)

Reactions: Off Label Use, Oesophagitis, Drug Ineffective FOR Unapproved Indication

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

Nexium
    Administration route: Oral
    Indication: Hernia
    Start date: 2006-01-01

Prilosec
    Administration route: Oral
    Indication: Dyspepsia

Prilosec
    Administration route: Oral
    Indication: Hernia

Other drugs received by patient: Premarin



Possible Prilosec side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-08-02

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, Gastric Disorder, Gastric Haemorrhage, Stress, Bipolar Disorder, Staphylococcal Infection, Sinus Disorder, Insomnia, Ulcer Haemorrhage, Depressed Mood

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

Seroquel
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral

Other drugs received by patient: Xanax; Adderall 10



Possible Prilosec side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 66 year old female, weighing 81.6 kg (179.5 pounds)

Reactions: Off Label Use, Drug Ineffective, Gastric Ulcer

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

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral
    Indication: Gastric Ulcer

Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral
    Indication: Gastric Ulcer

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Zocor; Liver OIL; Loratadine; Ascorbic Acid; Atenolol; Calcium Tablet; Coq10; Multi-Vitamins



Possible Prilosec side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 44 year old male, weighing 85.3 kg (187.7 pounds)

Reactions: Off Label Use, Nightmare, Tachyphrenia, Drug Ineffective, Dyspepsia, Disturbance in Attention

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

Seroquel
    Administration route: Oral
    Indication: Affective Disorder
    Start date: 2011-07-20

Seroquel
    Administration route: Oral

Other drugs received by patient: Trazodone Hydrochloride; Prozac; Nexium; Diazepam



Possible Prilosec side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 48 year old male

Reactions: Regurgitation, Drug Dose Omission, Drug Ineffective, Constipation, Off Label Use, Malaise, Impaired Self-Care, Decreased Appetite, Gastric Disorder, Stress, Gastric Haemorrhage, Bipolar Disorder, Staphylococcal Infection, Insomnia, Sinus Disorder, Ulcer Haemorrhage, Depressed Mood

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

Prilosec
    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

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Adderall 10; Xanax



Possible Prilosec side effects in 43 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 43 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Off Label Use, Anxiety, Arthralgia, Feeling Jittery, Insomnia, Dizziness, Tremor

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

Nexium
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Nexium
    Administration route: Oral
    Indication: Reflux Laryngitis

Prilosec
    Administration route: Oral
    Indication: Reflux Laryngitis

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Prilosec
    Administration route: Oral

Prilosec
    Administration route: Oral



Possible Prilosec side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: 71 year old female, weighing 81.6 kg (179.5 pounds)

Reactions: Drug Dose Omission, Off Label Use, Drug Ineffective, Oedema Peripheral, Gastric Disorder

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

Prilosec
    Administration route: Oral

Prilosec
    Dosage: generic
    Administration route: Oral

Prilosec OTC
    Administration route: Oral



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