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Zegerid (Omeprazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zegerid (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 (15)
Disability (1)

Reports by Reaction Type

Pain (7)Drug Ineffective (5)Abdominal Discomfort (3)Muscle Spasms (3)Hypoaesthesia (3)Hypertension (3)Confusional State (2)Product Substitution Issue (2)Hunger (2)Skin Discolouration (2)Abdominal Distension (2)Metabolic Disorder (2)

Possible Zegerid side effects in 65 year old female

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

Patient: 65 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Vomiting, Drug Ineffective, Hypoaesthesia, Headache, Abdominal Pain Upper, Malaise, Road Traffic Accident, Gastrointestinal Pain, Withdrawal Syndrome, Hypertension, Muscle Spasms, Neuralgia

Drug(s) suspected as cause:
Lyrica
    Dosage: 100 mg, 3x/day
    Indication: Neuralgia
    Start date: 2008-01-04

Neurontin
    Dosage: unk

Zegerid
    Dosage: unk
    Indication: Abdominal Pain Upper



Possible Zegerid side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-18

Patient:

Reactions: Ill-Defined Disorder

Drug(s) suspected as cause:
Zegerid



Possible Zegerid side effects in female

Reported by a pharmacist from United States on 2012-07-11

Patient: female

Reactions: Food Allergy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zegerid



Possible Zegerid side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: male

Reactions: Confusional State, Bowel Movement Irregularity, Pain, Gastritis Erosive, Cardiac Disorder, Emotional Distress, Fatigue, Hypomagnesaemia, Dizziness, Oesophageal Ulcer, Muscle Spasms

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Aciphex
    Dosage: unknown
    Administration route: Oral
    Start date: 2008-04-01
    End date: 2010-09-01

Dexilant
    Dosage: unknown
    Start date: 2008-04-01
    End date: 2010-09-01

Kapidex
    Dosage: unknown
    Start date: 2008-04-01
    End date: 2010-09-01

Nexium
    Dosage: unknown
    Start date: 2008-04-01
    End date: 2010-09-01

Prevacid
    Dosage: unknown
    Start date: 2008-04-01
    End date: 2010-09-01

Zegerid
    Dosage: unknown
    Start date: 2008-04-01
    End date: 2010-09-01



Possible Zegerid side effects in female

Reported by a physician from United States on 2012-05-22

Patient: female

Reactions: Drug Ineffective, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Omeprazole
    Indication: Erosive Oesophagitis

Omeprazole
    Indication: Gastrooesophageal Reflux Disease

Prilosec
    Indication: Gastrooesophageal Reflux Disease

Prilosec
    Indication: Erosive Oesophagitis

Zantac
    Indication: Erosive Oesophagitis

Zantac
    Indication: Gastrooesophageal Reflux Disease

Zegerid
    Indication: Gastrooesophageal Reflux Disease

Zegerid
    Indication: Erosive Oesophagitis



Possible Zegerid side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 69 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: Abdominal Discomfort, Increased Upper Airway Secretion, Pain, Hypophagia, Abdominal Distension, Unevaluable Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zegerid

Other drugs received by patient: Entocort EC



Possible Zegerid side effects in male

Reported by a individual with unspecified qualification from United States on 2012-05-08

Patient: male

Reactions: Confusional State, Bowel Movement Irregularity, Gastritis Erosive, Pain, Emotional Distress, Fatigue, Hypomagnesaemia, Dizziness, Heart Rate Irregular, Erosive Oesophagitis, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aciphex
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-04-01
    End date: 2010-09-01

Dexilant
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-04-01
    End date: 2010-09-01

Kapidex
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-04-01
    End date: 2010-09-01

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-04-01
    End date: 2010-09-01

Prevacid
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-04-01
    End date: 2010-09-01

Zegerid
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2008-04-01
    End date: 2010-09-01

Other drugs received by patient: Zantac



Possible Zegerid side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: 69 year old male, weighing 88.9 kg (195.6 pounds)

Reactions: Abdominal Discomfort, Hypophagia, Pain, Abdominal Distension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zegerid

Other drugs received by patient: Entocort EC



Possible Zegerid side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: female

Reactions: Drug Dose Omission, Chest Discomfort, Drug Ineffective

Drug(s) suspected as cause:
Four TO Five Other Products

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Prilosec
    Administration route: Oral

Zegerid



Possible Zegerid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-16

Patient: male, weighing 94.5 kg (207.9 pounds)

Reactions: Product Substitution Issue, Drug Ineffective

Drug(s) suspected as cause:
Zegerid
    Dosage: 40/1100mg qd orally
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-02-08

Zegerid
    Dosage: 40/1100mg qd orally
    Administration route: Oral
    Indication: Barrett's Oesophagus
    Start date: 2012-02-08



Possible Zegerid side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-22

Patient: male

Reactions: Abdominal Discomfort, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zegerid



Possible Zegerid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-13

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Product Substitution Issue, Drug Ineffective

Drug(s) suspected as cause:
Zegerid



Possible Zegerid side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-01

Patient: female

Reactions: LIP Swelling, Pruritus, Glossodynia, Muscle Swelling, Pain, Urticaria, Somnolence, Hunger, Skin Discolouration, Metabolic Disorder, Blood Glucose Increased, Stomatitis, Swelling Face, Drug Hypersensitivity, Skin Disorder, Hypoaesthesia, Rash, Discomfort, Tremor, Joint Swelling, Swelling, Pollakiuria, Eye Swelling, Vision Blurred, Arthritis, External Ear Inflammation, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prilosec
    Dosage: 1 df;;
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-09

Zegerid
    Dosage: 40 mg;qod;po, 40 mg;once;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-10

Zegerid
    Dosage: 40 mg;qod;po, 40 mg;once;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-08

Other drugs received by patient: Omeprazole; Vitamin D



Possible Zegerid side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-29

Patient: male

Reactions: Weight Decreased

Drug(s) suspected as cause:
Digoxin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zegerid
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Zegerid side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: female

Reactions: Glossodynia, Muscle Swelling, Hypersensitivity, Pain, Thirst, Hunger, Skin Discolouration, Metabolic Disorder, Eye Disorder, Blood Glucose Increased, Stomatitis, Skin Disorder, Hypoaesthesia, Tremor, Discomfort, Sleep Disorder, Joint Swelling, Vision Blurred, Pollakiuria, Hypertension, Arthritis, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prilosec
    Dosage: 1 df
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-09

Zegerid
    Dosage: 40 mg, qod, once, po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-10

Zegerid
    Dosage: 40 mg, qod, once, po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-08

Other drugs received by patient: Vitamin D; Omeprazole

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