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 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 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 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: 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 2012-08-17
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 2012-08-16
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 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 2012-08-14
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
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 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 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 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 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 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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