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 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 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 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 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 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 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 58 year old male
Reported by a individual with unspecified qualification from United States on 2012-08-22
Patient: 58 year old male
Reactions: Hypercholesterolaemia, Gastrooesophageal Reflux Disease, Chronic Obstructive Pulmonary Disease, Hypertension
Drug(s) suspected as cause:
Prilosec
Administration route: Oral
Symbicort
Dosage: 160/4.5 mcg
Zestril
Administration route: Oral
Other drugs received by patient: Ventolin HFA; Pravachol; Colace PO; Spiriva; Proventil-HFA; Hydrochlorothiazide; Hytrin; Wellbutrin; Norvasc; Iron PO
Possible Prilosec side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Eye Pruritus
Drug(s) suspected as cause:
Prilosec
Administration route: Oral
Prilosec OTC
Administration route: Oral
Possible Prilosec side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient:
Reactions: Gastrointestinal Haemorrhage, Haematuria, Oesophageal Varices Haemorrhage, Haemorrhoidal Haemorrhage, Dysgeusia, Diarrhoea, NO Therapeutic Response, Thrombocytopenia, Medication Residue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prilosec
Victrelis
Dosage: 800 mg, tid
Indication: Hepatitis C
Start date: 2012-05-15
End date: 2012-06-29
Warfarin Sodium
Other drugs received by patient: Metformin; Nadolol; Citalopram Hydrobromide; [composition Unspecified]; Ramipril; Actos
Possible Prilosec side effects in 25 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 25 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Drug Dose Omission, Vomiting, Drug Ineffective, Retching
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Dyspepsia
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Nexium
Administration route: Oral
Nexium
Administration route: Oral
Prilosec
Administration route: Oral
Other drugs received by patient: Aspirin; Flonase; Metoprolol Tartrate; Enalapril Maleate; Beclofen Pump; Miralax; Transderm Scop Patch
Possible Prilosec side effects in 55 year old female
Reported by a individual with unspecified qualification from United States on 2012-08-22
Patient: 55 year old female
Reactions: Post Polio Syndrome, Vomiting, Osteoporosis, Ear Infection, Chronic Obstructive Pulmonary Disease, Anxiety, Hypercholesterolaemia, Rheumatoid Arthritis, Dyspepsia
Drug(s) suspected as cause:
Prilosec
Administration route: Oral
Symbicort
Dosage: 80-4.5 mcg per actuation, hfaa inhaler, unknown
Other drugs received by patient: Proair HFA; Celexa; B Complex with Vitamin C; Flonase; Reclast; Vitamin D; Calcium; Zocor
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