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Exforge HCT (Amlodipine / Hydrochlorothiazide / Valsartan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Exforge HCT 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 (272)
Death (39)
Life Threatening Events (13)
Disability (6)

Reports by Reaction Type

Hypertension (24)Oedema Peripheral (19)Blood Pressure Increased (18)Dizziness (15)Dyspnoea (15)Blood Pressure Decreased (15)Blood Pressure Fluctuation (13)Malaise (12)Back Pain (12)Pain (11)Fall (11)Fatigue (11)

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

Possible Exforge HCT side effects in male

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

Patient: male

Reactions: General Physical Condition Abnormal, Coronary Artery Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT
    Dosage: 1 df, qd (1 tablet of unspecified dose once a day)
    Start date: 2011-11-01

Metformin HCL
    Dosage: 1 df, daily (1000/50 mg)
    Indication: Diabetes Mellitus
    Start date: 2009-08-01

Other drugs received by patient: Blodovit



Possible Exforge HCT side effects in female

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

Patient: female

Reactions: Oedema Peripheral, Blood Pressure Inadequately Controlled, Melanocytic Naevus, Renal Artery Stenosis

Drug(s) suspected as cause:
Exforge HCT

Other drugs received by patient: Lamotrigine; Lexapro; Rasilez; Omeprazole; Atorvastatin; Bisoprolol Fumarate; Wellbutrin; Tranxene; Laxoberon; Metamucil-2



Possible Exforge HCT side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Speech Disorder, Ischaemic Stroke, Paralysis

Drug(s) suspected as cause:
Exforge HCT

Other drugs received by patient: Lovaza; Ascorbic Acid; Probiotics; Fish OIL; Cymbalta; Vitamin D



Possible Exforge HCT side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Speech Disorder, Dyspnoea, Fatigue, Rotator Cuff Syndrome, Musculoskeletal Discomfort, Carpal Tunnel Syndrome, Thyroid Neoplasm, Paraesthesia

Drug(s) suspected as cause:
Exforge
    Dosage: 5 aml/160 vals, qd

Exforge HCT
    Dosage: 1 df, qd

Hydrocodone Bitartrate
    Dosage: 5-500 mg, unk
    Indication: Pain

Other drugs received by patient: Lovaza; Fish OIL; Vitamin D; Probiotics; Cymbalta; Ascorbic Acid



Possible Exforge HCT side effects in female

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

Patient: female

Reactions: Localised Infection, Depression

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-17

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-17

Patient: male

Reactions: Joint Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in male

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

Patient: male

Reactions: Hepatic Infection, Kidney Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a physician from Australia on 2012-08-13

Patient: female

Reactions: Back Pain, Drug Intolerance, Feeling Abnormal, Constipation, Blood Pressure Fluctuation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in male

Reported by a consumer/non-health professional from Argentina on 2012-08-10

Patient: male

Reactions: Oedema Peripheral, Infarction

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-09

Patient: female

Reactions: Asthma, Cough

Drug(s) suspected as cause:
Exforge HCT

Other drugs received by patient: Bisoprolol Fumarate and Hydrochlorothiazide



Possible Exforge HCT side effects in female

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

Patient: female

Reactions: Poisoning

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in male

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

Patient: male

Reactions: Infectious Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in 86 year old female

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

Patient: 86 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Dyspnoea, Angina Pectoris

Drug(s) suspected as cause:
Exforge HCT
    Dosage: 5 mg, unk
    Administration route: Oral

Exforge HCT
    Dosage: 12.5 mg, unk
    Administration route: Oral

Exforge HCT
    Dosage: 160 mg, unk
    Administration route: Oral

Metoprolol Tartrate
    Dosage: 200 mg, qd
    Administration route: Oral

Zocor
    Dosage: 20 mg, qd
    Administration route: Oral



Possible Exforge HCT side effects in 47 year old male

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

Patient: 47 year old male

Reactions: Renal Injury, Blood Pressure Increased, Blood Uric Acid Increased, Feeling Hot

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

Exforge HCT
    Dosage: 1 tablet daily
    Indication: Hypertension
    Start date: 2012-01-01



Possible Exforge HCT side effects in female

Reported by a pharmacist from Germany on 2012-07-31

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Wrong Technique in Drug Usage Process, Recurrent Cancer, Dizziness, Blood Pressure Decreased, Hepatic Neoplasm Malignant Recurrent, Breast Cancer Recurrent

Drug(s) suspected as cause:
Exforge HCT
    Dosage: 0.5 df, qd

Exforge HCT
    Dosage: 1 df(160 mg vals, 10 mg amlo and 25 mg hctz), qd
    Indication: Hypertension
    Start date: 2011-05-02



Possible Exforge HCT side effects in male

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

Patient: male

Reactions: Ankle Fracture, Blood Pressure Decreased

Drug(s) suspected as cause:
Exforge HCT

Other drugs received by patient: Metformin Hydrochloride



Possible Exforge HCT side effects in male

Reported by a consumer/non-health professional from Ecuador on 2012-07-30

Patient: male

Reactions: Abdominal Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 50 year old male

Reactions: Upper Limb Fracture

Drug(s) suspected as cause:
Clonidine
    Indication: Hypertension
    Start date: 1986-01-01

Clonidine
    Indication: Blood Pressure Increased
    Start date: 1986-01-01

Exforge HCT
    Indication: Blood Pressure Increased

Exforge HCT
    Indication: Hypertension



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Australia on 2012-07-25

Patient: female

Reactions: Back Pain, Drug Intolerance, Constipation, Feeling Abnormal, Blood Pressure Fluctuation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a pharmacist from Germany on 2012-07-17

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Wrong Technique in Drug Usage Process, Recurrent Cancer, Dizziness, Blood Pressure Decreased, Hepatic Neoplasm Malignant Recurrent, Breast Cancer Recurrent

Drug(s) suspected as cause:
Exforge HCT
    Dosage: 0.5 df, unk

Exforge HCT
    Dosage: 1 df(160 mg vals, 10 mg amlo and 25 mg hctz), qd
    Indication: Hypertension
    Start date: 2011-05-02



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-07-04

Patient: female

Reactions: Malaise, Wrong Technique in Drug Usage Process, Lung Disorder, Dyspnoea, Nasal Congestion, Infarction

Drug(s) suspected as cause:
Exforge HCT
    Dosage: half tablet (unspecified) daily
    Start date: 2010-06-01

Exforge HCT
    Dosage: 1 tablet (160/5/12.5 mg) daily
    Indication: Hypertension
    Start date: 2010-06-01

Other drugs received by patient: Aspirin



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-07-03

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-07-02

Patient: female

Reactions: Blood Pressure Increased, Depression, Cerebral Cyst

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Ecuador on 2012-07-02

Patient: female

Reactions: Visual Impairment, Benign Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-06-29

Patient: female

Reactions: Speech Disorder, Cerebral Infarction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Exforge HCT



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-06-29

Patient: female

Reactions: HIP Fracture, Femur Fracture, Swelling, Pain, Blood Pressure Fluctuation, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT
    Dosage: 2 df (vals 160 mg, amlo 5 mg, hydr 12.5 mg), per day
    Start date: 2012-05-01

Exforge HCT
    Dosage: 1 df(vals 160 mg, amlo 5 mg, hydr 12.5 mg), per day
    Indication: Hypertension
    Start date: 2012-05-28

Other drugs received by patient: Lopressor; Cilostazol; Clopidogrel Bisulfate; Dabigatran Etexilate



Possible Exforge HCT side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-06-29

Patient: male

Reactions: Pericarditis, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge HCT
    Dosage: 1 df (320 mg vals/10 mg amlo/ 25 mg hct), daily
    Indication: Hypertension
    Start date: 2010-06-01

Exforge HCT
    Dosage: 1 df (160 mg vals/ 5 mg amlo/ 12.5 mg hct), daily
    Start date: 2012-06-01



Possible Exforge HCT side effects in female

Reported by a consumer/non-health professional from Ecuador on 2012-06-28

Patient: female

Reactions: Joint Dislocation, Fall

Drug(s) suspected as cause:
Exforge HCT

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