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, 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 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 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: 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 2012-08-17
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 2012-08-15
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 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 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 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 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
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 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 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 2012-07-02
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 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 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 Ecuador on 2012-06-28
Patient: female
Reactions: Joint Dislocation, Fall
Drug(s) suspected as cause:
Exforge HCT
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