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Tribenzor (Olmesartan / Amlodipine / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tribenzor 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 (13)

Reports by Reaction Type

Syncope (3)Oedema Peripheral (2)Vomiting (2)Joint Swelling (2)Dehydration (2)Confusional State (1)Fatigue (1)Neuropathy Peripheral (1)Neck Pain (1)Lung Neoplasm Malignant (1)Eye Movement Disorder (1)Fluid Retention (1)

Possible Tribenzor side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male

Reactions: Lung Neoplasm Malignant

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in 51 year old male

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

Patient: 51 year old male, weighing 147.4 kg (324.3 pounds)

Reactions: Brain Neoplasm Benign, Neck Pain, Joint Swelling, Oedema Peripheral, Chest Pain, Eye Movement Disorder, Headache

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male

Reactions: Dehydration, Loss of Consciousness

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: 63 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Joint Swelling, Oedema Peripheral, Eye Swelling, Thyroid Neoplasm, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benicar
    Dosage: per oral ; per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-01
    End date: 2012-05-01

Benicar
    Dosage: per oral ; per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Tribenzor
    Dosage: 40/5/12.5mg (qd),per oral ; per oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-01

Tribenzor
    Dosage: 40/5/12.5mg (qd),per oral ; per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-01

Other drugs received by patient: Metoprolol Succinate



Possible Tribenzor side effects in 73 year old male

Reported by a individual with unspecified qualification from United States on 2012-06-13

Patient: 73 year old male, weighing 109.8 kg (241.5 pounds)

Reactions: Neuropathy Peripheral, Chest Discomfort, Pain in Extremity, Diarrhoea, Muscle Spasms, Venous Occlusion, Arrhythmia

Drug(s) suspected as cause:
Welchol
    Dosage: per oral
    Administration route: Oral
    Indication: Bile Acid Malabsorption

Azor
    Dosage: 5/40mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-01

Tribenzor
    Dosage: per oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-03-01

Other drugs received by patient: Simvastatin; Benicar



Possible Tribenzor side effects in 51 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-11

Patient: 51 year old female, weighing 74.8 kg (164.7 pounds)

Reactions: Alopecia

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in 63 year old female

Reported by a physician from United States on 2012-06-11

Patient: 63 year old female, weighing 32.2 kg (70.8 pounds)

Reactions: Vomiting, Syncope, Hyperhidrosis, Atrioventricular Block First Degree, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-22

Patient: female

Reactions: Hypotension, Adrenal Insufficiency

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benicar HCT
    Dosage: per oral
    Administration route: Oral
    Indication: Hypertension

Tribenzor
    Dosage: per oral
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Calcium Channel Blockers; ACE Inhibitor (Ace Inhibitor Nos)



Possible Tribenzor side effects in 55 year old male

Reported by a physician from United States on 2012-03-08

Patient: 55 year old male

Reactions: Visual Impairment, Eye Disorder, Blood Pressure Decreased

Drug(s) suspected as cause:
Tribenzor

Other drugs received by patient: Lotrel



Possible Tribenzor side effects in female

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

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Movement Disorder, Syncope, Blood Potassium Decreased, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-04

Patient: female

Reactions: Confusional State, Vomiting, Nausea, Restlessness, Urine Output Decreased, Thirst, Somnolence, Convulsion, Myalgia, Syncope, Fatigue, Muscle Fatigue, Heart Rate Increased, DRY Mouth, Dizziness, Asthenia, Anuria

Drug(s) suspected as cause:
Tribenzor



Possible Tribenzor side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2011-10-06

Patient: 71 year old male, weighing 90.7 kg (199.6 pounds)

Reactions: Blindness Unilateral

Drug(s) suspected as cause:
Tribenzor

Other drugs received by patient: Metformin HCL; Twynsta (Telmisartan / Amlodipine); Coreg; Aspirin

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