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Prilosec (Omeprazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prilosec (Omeprazole) 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 (1598)
Death (4)
Life Threatening Events (32)
Disability (37)

Reports by Reaction Type

Drug Ineffective (837)Drug Dose Omission (478)Gastrooesophageal Reflux Disease (450)Malaise (235)Dyspepsia (225)Vomiting (155)Pain (147)Off Label Use (133)Intentional Drug Misuse (132)Abdominal Pain Upper (117)Nausea (99)Abdominal Discomfort (92)

Below are a few examples of reports where side effects / adverse reactions may be related to Prilosec (Omeprazole). For a complete list or a specific selection of reports, please use the links above.

Possible Prilosec side effects in 48 year old female

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

Patient: 48 year old female, weighing 113.9 kg (250.6 pounds)

Reactions: Nicotine Dependence, Vitamin D Deficiency, Generalised Anxiety Disorder, Pruritus, Intentional Drug Misuse, Treatment Noncompliance, Hypokalaemia, Suicidal Ideation, Fatigue, Oesophagitis, Obesity, Bacterial Infection, Oedema, Depression, Hallucination, Gastrooesophageal Reflux Disease, Cough, Migraine, Pain in Extremity, Musculoskeletal Pain, Vaginal Discharge, Self Injurious Behaviour, Dysmenorrhoea, Suicide Attempt, Vaginal Infection, Hypertension

Adverse event resulted in: life threatening event

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

Seroquel
    Administration route: Oral

Seroquel
    Dosage: 100mg 1/2 tab until monday then whole 100 mg
    Administration route: Oral

Other drugs received by patient: Prozac; Buspar; Albuterol; Naprosyn; Aspirin; Fluticasone Propionate; Hydrodiuril; K DUR / Klor-CON; Vistaril; Multi-Vitamin



Possible Prilosec 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 Prilosec side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Benadryl
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Demerol
    Dosage: unk

Keflex
    Dosage: unk

Prevacid
    Dosage: unk

Prilosec
    Dosage: unk

Tobramycin
    Dosage: unk



Possible Prilosec 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 Prilosec 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 Prilosec side effects in 36 year old female

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

Patient: 36 year old female, weighing 65.3 kg (143.7 pounds)

Reactions: Gallbladder Enlargement, Increased Upper Airway Secretion, Pneumonia, Vomiting, Pyrexia, Somnolence, Chronic Obstructive Pulmonary Disease, Loss of Consciousness, Sepsis, Abdominal Distension, Cough

Adverse event resulted in: life threatening event, hospitalization

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

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs, bid

Other drugs received by patient: Combivent; Clonazepam; Serrex Iron; Diltiazem



Possible Prilosec 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 Prilosec side effects in 71 year old male

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

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

Reactions: Dyspnoea, Hiatus Hernia, Dilatation Ventricular, Headache, Joint Swelling, Oedema Peripheral, Gastrooesophageal Reflux Disease, Blood Creatinine Increased

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral
    Indication: Stent Placement

Prilosec
    Dosage: generic
    Administration route: Oral

Prilosec
    Administration route: Oral
    Indication: Dyspepsia

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

Other drugs received by patient: Xyzal; Vitamin D; Amlodipine; Donepezil HCL; Hydralazine HCL; Lipitor



Possible Prilosec 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 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 2012-08-24

Patient: female

Reactions: Adverse Event

Drug(s) suspected as cause:
Dexilant

Prilosec
    Administration route: Oral

Other drugs received by patient: Nexium



Possible Prilosec side effects in 83 year old female

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

Patient: 83 year old female

Reactions: Drug Ineffective, Dysphonia, Sinus Disorder, Sinusitis, Gastrooesophageal Reflux Disease

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

Prilosec
    Administration route: Oral

Symbicort

Other drugs received by patient: Dexilant



Possible Prilosec side effects in 94 year old female

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

Patient: 94 year old female

Reactions: Pneumonia, Dyspnoea, Nasopharyngitis, Hiatus Hernia, Drug Ineffective, Nausea, Post Procedural Complication, Anaesthetic Complication, Intentional Drug Misuse, Hernia, Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anesthesia

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

Nexium
    Administration route: Oral

Prilosec
    Administration route: Oral

Prilosec OTC
    Administration route: Oral



Possible Prilosec side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Drug Dose Omission, Respiratory Disorder, Drug Ineffective, Dyspepsia, Feeling Abnormal

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

Prilosec
    Administration route: Oral

Symbicort
    Indication: Asthma
    Start date: 2011-04-01



Possible Prilosec side effects in 52 year old female

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

Patient: 52 year old female, weighing 95.3 kg (209.7 pounds)

Reactions: Drug Dose Omission, Drug Ineffective, Adverse Drug Reaction, Urticaria, Hepatitis, Constipation, Dermatitis, Lipoma, Chronic Sinusitis, Depression, Salivary Hypersecretion, Gastrooesophageal Reflux Disease, Blood Alkaline Phosphatase Increased, Cellulitis, Alanine Aminotransferase Increased, Hypoaesthesia, Hyperlipidaemia, Aspartate Aminotransferase Increased, Hypothyroidism, Multiple Allergies, Nasal Polyps

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Start date: 2008-08-28

Prilosec
    Administration route: Oral

Other drugs received by patient: Advil; Triamcinolone Acetonide; Hydroxyzine HCL; Clobetasol Propionate; Clobetasol Propionate; Vitamin D; Glucosamine MSM Complex



Possible Prilosec side effects in female

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

Patient: female

Reactions: Foot Fracture, Osteoporosis, Pain in Extremity, Pain, Mental Disorder, Osteopenia

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Start date: 2002-11-07

Nexium
    Administration route: Oral
    Start date: 2007-05-26

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 1995-01-01
    End date: 2010-01-01

Nexium
    Dosage: 40 mg capsule as directed
    Administration route: Oral
    Start date: 2011-09-12

Nexium
    Administration route: Oral
    Start date: 2006-11-06

Nexium
    Administration route: Oral
    Start date: 2006-02-07

Prilosec
    Indication: Gastrooesophageal Reflux Disease
    Start date: 1995-01-01
    End date: 2010-01-01

Other drugs received by patient: Armodafinil; BUT / ASA / Caff; Celexa; Elavil; Prednisone TAB; Vicodin / Norco; Vicodin / Norco; Celebrex; Sumatriptan; Stelazine; Corgard; Corgard; Fioricet; Fioricet; Biaxin XL; Methylprednisolone; Robaxin; Celebrex; BUT / ASA / Caff; Sumatriptan; Cephalexin; Prednisone TAB; Prednisone TAB; Vicodin / Norco; Amitriptyline HCL; Zyrtec; Klonopin; Klonopin; Lyrica; Vicodin / Norco; Vicodin / Norco; Omacor; Corgard; Elavil; Skelaxin; Cephalexin; Amitriptyline HCL; Robaxin; Klonopin; Tequin; Corgard; Lomotil; Celebrex; Lyrica; Celexa; Benadryl; Risperdal; Risperdal; Fioricet; Fioricet; Robaxin; Robaxin; Celexa; Claritin-D; Librium



Possible Prilosec side effects in 39 year old male

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

Patient: 39 year old male

Reactions: Drug Dose Omission, Drug Effect Decreased, Dyspnoea, Dyspepsia, Cough

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

Prilosec
    Administration route: Oral

Symbicort



Possible Prilosec side effects in 61 year old female

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

Patient: 61 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Pruritus Generalised, Intentional Drug Misuse, Post-Traumatic Epilepsy, Gastrooesophageal Reflux Disease, Muscle Disorder, Gastritis, Disability

Drug(s) suspected as cause:
Prilosec
    Administration route: Oral
    Indication: Oesophageal Pain
    Start date: 2009-07-01
    End date: 2009-09-01

Prilosec
    Administration route: Oral
    Start date: 2012-08-01
    End date: 2012-08-01

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2009-07-01
    End date: 2009-09-01

Prilosec
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-09-01

Prilosec
    Administration route: Oral
    Start date: 2012-08-01
    End date: 2012-08-01

Prilosec
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-09-01

Other drugs received by patient: Atenolol; Keppra; Norvasc



Possible Prilosec side effects in 57 year old male

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

Patient: 57 year old male

Reactions: Drug Dose Omission, Dysphagia, Drug Ineffective

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

Prilosec
    Administration route: Oral

Prilosec OTC
    Administration route: Oral



Possible Prilosec side effects in female

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

Patient: female

Reactions: Drug Dose Omission, Dyspnoea

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

Prilosec
    Administration route: Oral



Possible Prilosec side effects in 77 year old male

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

Patient: 77 year old male

Reactions: Myalgia, Pain, Musculoskeletal Stiffness, Muscular Weakness, Gait Disturbance, Ulcer Haemorrhage

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

Crestor
    Administration route: Oral

Prilosec
    Administration route: Oral

Other drugs received by patient: Nexium



Possible Prilosec side effects in 37 year old female

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

Patient: 37 year old female

Reactions: Drug Ineffective, Maternal Exposure During Pregnancy, Gastrooesophageal Reflux Disease

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

Prilosec
    Administration route: Oral



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 male

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

Patient: male, weighing 106.6 kg (234.5 pounds)

Reactions: Diarrhoea, Flatulence, Headache, Lethargy, Abdominal Pain Upper

Drug(s) suspected as cause:
Prilosec



Possible Prilosec side effects in 58 year old female

Reported by a physician from United States on 2012-08-23

Patient: 58 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Vomiting, Retinal Disorder, Blindness, Haematemesis

Drug(s) suspected as cause:
Effexor XR
    Dosage: unk
    Administration route: Oral
    Indication: Depression
    Start date: 1999-01-01

Effexor XR
    Dosage: 300 mg, daily
    Administration route: Oral
    Indication: Chronic Fatigue Syndrome

Prilosec
    Dosage: 20 mg, as needed
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Adderall; Doxepin; Keflex; Morphine; Norco



Possible Prilosec side effects in 46 year old male

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

Patient: 46 year old male

Reactions: Drug Dose Omission, Pain, Intentional Drug Misuse, Abdominal Discomfort, Barrett's Oesophagus, Adverse Event, Gallbladder Disorder, Erosive Oesophagitis

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

Prilosec
    Administration route: Oral



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 63 year old female

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

Patient: 63 year old female

Reactions: Drug Dose Omission, Pain

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

Prilosec
    Administration route: Oral



Possible Prilosec side effects in 41 year old female

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

Patient: 41 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Drug Ineffective, Gastrooesophageal Reflux Disease

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: Clonazepam



Possible Prilosec side effects in 41 year old female

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

Patient: 41 year old female

Reactions: Malaise, Drug Hypersensitivity, Urticaria, Headache, Gastric Ulcer, Gastrooesophageal Reflux Disease, Sinusitis, Abdominal Pain Upper

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

Symbicort
    Dosage: 160/4.5 mcg one puff twice a day

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