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Exforge (Amlodipine / 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 (Amlodipine / Valsartan) 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 (801)
Death (171)
Life Threatening Events (21)
Disability (14)

Reports by Reaction Type

Blood Pressure Increased (85)Death (64)Oedema Peripheral (57)Cerebrovascular Accident (57)Fall (46)Hypertension (45)Diabetes Mellitus (44)Malaise (40)Pneumonia (35)Dyspnoea (33)Dizziness (28)Blood Glucose Increased (27)

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

Possible Exforge side effects in female

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

Patient: female

Reactions: Guillain-Barre Syndrome, Movement Disorder, Abdominal Pain, Quadriplegia, Diarrhoea, Respiratory Arrest, Vertigo, Asthenia, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Exforge
    Dosage: 1 df qd (160 mg val /5 mg amlo) daily
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2012-03-01

Tegretol

Other drugs received by patient: Pentoxifylline; Servilan



Possible Exforge side effects in male

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

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge
    Dosage: 320/5 mg, unk

Rasilez
    Dosage: 300 mg, unk
    Indication: Hypertension



Possible Exforge side effects in female

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

Patient: female

Reactions: Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in male

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

Patient: male

Reactions: Cholelithiasis, Dyspepsia, Abdominal Distension, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge

Other drugs received by patient: Norvasc; Lopid



Possible Exforge side effects in male

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

Patient: male

Reactions: Emphysema, Hypokinesia, Dysphagia, Neck Pain, Ischaemic Stroke, Lung Infection, Headache

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan
    Indication: Hypertension

Exforge
    Dosage: 1 df (160 mg vals and 5 mg amlo), daily
    Indication: Hypertension
    Start date: 2012-04-01



Possible Exforge side effects in male

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

Patient: male

Reactions: Blood Pressure Increased, Drug Intolerance, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Exforge



Possible Exforge 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 side effects in female

Reported by a consumer/non-health professional from Argentina on 2012-08-21

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Pneumonia, Pyrexia, Hypertension, Cough

Drug(s) suspected as cause:
Exforge
    Dosage: 1 tablet and a half (160/5 mg) daily
    Indication: Hypertension
    Start date: 2012-06-30

Exforge
    Dosage: a quarter of a pill (160/5 mg)



Possible Exforge side effects in female

Reported by a consumer/non-health professional from Ecuador on 2012-08-21

Patient: female

Reactions: Bronchitis, Feeling Abnormal, Ankle Fracture, Discomfort, Cough, Influenza

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in 78 year old

Reported by a physician from Japan on 2012-08-20

Patient: 78 year old

Reactions: Urinary Incontinence, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Exforge
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Gascon
    Dosage: unk
    Administration route: Oral
    Indication: Gastritis

Lipitor
    Dosage: unk
    Administration route: Oral
    Indication: Hyperlipidaemia

Lyrica
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2012-07-14
    End date: 2012-07-19

Merislon
    Dosage: unk
    Administration route: Oral
    Indication: Meniere's Disease

Vitamin B12
    Dosage: unk
    Administration route: Oral
    Indication: Neuropathy Peripheral

Other drugs received by patient: Polyful



Possible Exforge side effects in male

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

Patient: male

Reactions: Emphysema, Dysphagia, Hypokinesia, Neck Pain, Lung Infection, Headache, Infarction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in male

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

Patient: male

Reactions: Death, Gastrointestinal Haemorrhage, Skin Discolouration, Feeling Abnormal, Haematemesis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Exforge

Other drugs received by patient: Carvedilol; Pantoprazole



Possible Exforge side effects in male

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

Patient: male

Reactions: Laryngeal Cancer

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in 90 year old female

Reported by a pharmacist from Japan on 2012-08-17

Patient: 90 year old female

Reactions: Gastrointestinal Erosion, Feeling Abnormal, Haematemesis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxazosin Mesylate
    Administration route: Oral

Exforge
    Dosage: every day
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-07-29
    End date: 2012-07-30

Omeprazole
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-07-24
    End date: 2012-07-27

Omeprazole
    Indication: Helicobacter Infection
    Start date: 2012-07-27
    End date: 2012-07-29

Valsartan and Hydrochlorothiazide
    Dosage: every day
    Administration route: Oral



Possible Exforge side effects in male

Reported by a consumer/non-health professional from Argentina on 2012-08-16

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in male

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

Patient: male

Reactions: Colon Cancer Recurrent

Drug(s) suspected as cause:
Exforge
    Dosage: 320/10mg, unk

Exforge
    Dosage: 320/5mg, unk

Other drugs received by patient: Aspirin; Celexa; Clonidine



Possible Exforge side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-14

Patient: female

Reactions: Metastases To Liver, Colorectal Cancer Metastatic, Metastases To Bone, Metastases To Lung

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male

Reactions: Blood Potassium Abnormal, Blood Testosterone Decreased, Device Dislocation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge

Other drugs received by patient: Trilipix; Clonidine; Cardizem LA



Possible Exforge side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-13

Patient: female

Reactions: Diarrhoea, Diabetes Mellitus, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge

Other drugs received by patient: Lanoxin



Possible Exforge side effects in

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

Patient:

Reactions: Death, Oedema Peripheral

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-13

Patient: male

Reactions: Osteoarthritis

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-13

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in male

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

Patient: male

Reactions: Lung Neoplasm Malignant, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-10

Patient: 80 year old male

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Diovan
    Dosage: 80 mg, daily
    Administration route: Oral
    Indication: Hypertension

Exforge
    Dosage: 1 df, daily
    Administration route: Oral

Other drugs received by patient: Amlodipine



Possible Exforge side effects in female

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

Patient: female

Reactions: Blood Pressure Increased, Ankle Fracture, Fall

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in 58 year old female

Reported by a physician from Israel on 2012-08-07

Patient: 58 year old female

Reactions: Dyspnoea, Dependence, Pleural Effusion, Ascites

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in female

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

Patient: female

Reactions: NO Therapeutic Response, Dizziness, Blood Sodium Decreased

Adverse event resulted in: hospitalization

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

Exforge
    Dosage: 1 df(320 mg val/5 mg amlo)

Exforge
    Dosage: 1 df(160 mg val/5 mg amlo)
    Start date: 2012-05-01

Other drugs received by patient: Atenolol; Ostelin; Oxycodone HCL; Macu-Vision; Coloxyl with Senna



Possible Exforge side effects in female

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

Patient: female

Reactions: Blindness Unilateral, Ulcer, Gastric Disorder, Eye Disorder

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in female

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

Patient: female

Reactions: Vascular Graft, Procedural Complication, Muscle Neoplasm

Adverse event resulted in: death

Drug(s) suspected as cause:
Exforge



Possible Exforge side effects in female

Reported by a physician from Japan on 2012-08-06

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Jaundice, Blood Bilirubin Increased, Fatigue, Drug-Induced Liver Injury, Alanine Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Equa
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-04-16
    End date: 2012-05-17

Exforge
    Dosage: 1 df daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-16
    End date: 2012-05-17

Other drugs received by patient: Rabeprazole Sodium; Metformin HCL; Yodel S

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