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Tekturna HCT (Aliskiren / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tekturna HCT (Aliskiren / Hydrochlorothiazide) 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 (32)
Life Threatening Events (3)

Reports by Reaction Type

Feeling Abnormal (7)Blood Pressure Increased (5)Headache (4)Oedema Peripheral (4)Dizziness (4)Hypertension (4)Hypersensitivity (3)Diabetes Mellitus (3)Drug Ineffective (3)Blood Pressure Inadequately Controlled (3)Nausea (3)Coronary Artery Disease (3)

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

Possible Tekturna HCT side effects in female

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

Patient: female

Reactions: Neoplasm Malignant, Diabetes Mellitus, Oedema

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in female

Reported by a pharmacist from United States on 2012-06-19

Patient: female

Reactions: Burning Sensation, Hypersensitivity, Pruritus, Hypopnoea

Drug(s) suspected as cause:
Catapres
    Dosage: 0.2 mg

Motrin

Hydrochlorothiazide

Irbesartan
    Indication: Hypertension
    Start date: 2012-04-05
    End date: 2012-04-05

Toprol-XL
    Dosage: 25 mg

Azor

Benicar HCT

Micardis
    Dosage: 40 mg

Tekturna HCT

Atacand HCT

Amlodipine Besylate

Bystolic

Atenolol
    Dosage: 50 mg

Lisinopril
    Dosage: 10 mg

Other drugs received by patient: Xyzal; Diovan HCT



Possible Tekturna HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: female

Reactions: LIP Swelling, Swelling Face, Pruritus, Oedema Peripheral

Drug(s) suspected as cause:
Diovan HCT

Tekturna HCT



Possible Tekturna HCT side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 81 year old female, weighing 51.7 kg (113.8 pounds)

Reactions: Blood Pressure Increased, Drug Level Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: male

Reactions: Asthma, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: 65 year old female

Reactions: Nausea, Heart Rate Increased, Blood Pressure Inadequately Controlled, Dizziness, Hypertension, Feeling Abnormal

Drug(s) suspected as cause:
Tekturna
    Dosage: 150 mg (1 in the night), oral; 150 mg, oral
    Administration route: Oral

Tekturna HCT
    Dosage: 150 mg of alisk and 12.5 mg (1 in the morning), oral; oral
    Administration route: Oral
    Start date: 2011-01-01

Other drugs received by patient: Toprol-XL



Possible Tekturna HCT side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: male

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in 81 year old female

Reported by a physician from United States on 2012-03-09

Patient: 81 year old female

Reactions: Joint Swelling, Swelling, Oedema Peripheral, Blood Disorder

Drug(s) suspected as cause:
Amlodipine
    Dosage: 5 mg, qd

Tekturna HCT
    Dosage: 1 df,(300/12.5 mg) qd

Warfarin Sodium
    Dosage: 1 to 2 mg once a day

Other drugs received by patient: Pepcid; Acetaminophen; Phillips (Polycarbophil Calcium); Aspirin; Ascorbic Acid; Citracal + D (Calcium Citrate, Ergocalciferol); Vitamin D; Amiodarone HCL; Magnesium (Magnesium); Klor-CON; Lasix; Xanax; Asacol; Metoprolol Tartrate



Possible Tekturna HCT side effects in 38 year old male

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: 38 year old male

Reactions: Drug Ineffective, Hypertension

Drug(s) suspected as cause:
Tekturna HCT
    Dosage: 150aliskieren /12.5 hct per day, oral
    Administration route: Oral

Exforge
    Dosage: 10 amlodipin/ 320 vals per day



Possible Tekturna HCT side effects in 65 year old male

Reported by a physician from United States on 2012-03-09

Patient: 65 year old male

Reactions: Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna HCT

Other drugs received by patient: Azithromax (Azithromycin); Prednisolone



Possible Tekturna HCT side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: 40 year old female

Reactions: Bowel Movement Irregularity, Hypersensitivity, Aphasia, Oral Pain, Dehydration, Dysuria, Vision Blurred, Feeling Abnormal, Inflammation

Drug(s) suspected as cause:
Benicar

Monopril

Tekturna HCT
    Dosage: 1 df, qd

Lisinopril

Other drugs received by patient: Advil (Mefenamic Acid)



Possible Tekturna HCT side effects in 62 year old male

Reported by a physician from United States on 2012-03-09

Patient: 62 year old male, weighing 170.5 kg (375.1 pounds)

Reactions: Angioedema, Skin Discolouration, Urticaria, Rash

Drug(s) suspected as cause:
Tekturna HCT

Other drugs received by patient: Livalo; Tamsulosin HCL; Norvasc; Aspirin; Viagra; Flunase (Fluticasone Propionate)



Possible Tekturna HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: female

Reactions: Blood Pressure Increased, Heart Rate Decreased, Drug Ineffective, Headache, Blood Pressure Fluctuation

Drug(s) suspected as cause:
Tekturna HCT
    Dosage: 300 mg alis and 12.5 mg hct, once daily in the morning, oral
    Administration route: Oral
    Indication: Hypertension

Valturna
    Dosage: 300 mg alis and 320 mg vals
    Indication: Hypertension
    Start date: 2011-04-20

Antihypertensive Drugs (NO Ingredients / Substances)
    Indication: Hypertension

Extra Strength Tylenol
    Indication: Headache

Other drugs received by patient: Isobar (Methylclothiazide, Triamterene); Hydralazine HCL



Possible Tekturna HCT side effects in 62 year old male

Reported by a physician from United States on 2012-03-09

Patient: 62 year old male

Reactions: Blood Albumin Increased, Renal Impairment, Blood Creatinine Increased, Hypokalaemia

Drug(s) suspected as cause:
Valturna
    Dosage: 1 df, daily

Tekturna HCT
    Dosage: 1 df, at night



Possible Tekturna HCT side effects in 40 year old female

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: 40 year old female

Reactions: Bowel Movement Irregularity, Hypersensitivity, Aphasia, Oral Pain, Dehydration, Dysuria, Vision Blurred, Feeling Abnormal, Inflammation

Drug(s) suspected as cause:
Lisinopril

Tekturna HCT
    Dosage: 1 df, qd

Benicar

Monopril

Other drugs received by patient: Advil (Mefenamic Acid)



Possible Tekturna HCT side effects in female

Reported by a individual with unspecified qualification from United States on 2012-02-29

Patient: female

Reactions: Blood Pressure Increased, LIP Swelling, Blood Urine Present, Drug Ineffective, Urinary Incontinence, Rash, Swollen Tongue, Urine Flow Decreased, Pharyngeal Oedema, Renal Impairment, Dysuria, Oedema Peripheral, Renal Pain, Oedema Mouth

Drug(s) suspected as cause:
Diovan HCT
    Dosage: unk ukn, unk

Tekamlo
    Dosage: 300 mg alis and 10 mg amlo, 1 df
    End date: 2011-04-15

Tekturna HCT
    Dosage: unk ukn, unk

Tekturna
    Dosage: 300 mg, qd

Diovan
    Dosage: 80 mg, unk

Other drugs received by patient: Aspirin



Possible Tekturna HCT side effects in 87 year old female

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

Patient: 87 year old female

Reactions: Diplopia, Humerus Fracture, Vomiting, Wrist Fracture, Fall

Drug(s) suspected as cause:
Acetaminophen

Tekturna HCT
    Dosage: 1 df, qd

Other drugs received by patient: Multivitamin; Metoprolol; Metolazone



Possible Tekturna HCT side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20

Patient: female, weighing 72.7 kg (159.9 pounds)

Reactions: Weight Decreased, Polydipsia, Glycosylated Haemoglobin Increased, Glycosuria, Polyuria, Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna HCT

Other drugs received by patient: Levothyroxine Sodium; Omeprazole; Paxil



Possible Tekturna HCT side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-13

Patient: male

Reactions: Coronary Artery Disease, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna HCT
    Dosage: 1 df (300/25mg), qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-08-10

Tekturna
    Dosage: 150 mg, unk
    Indication: Hypertension
    Start date: 2007-07-13

Other drugs received by patient: Carvedilol; Amlodipine Besilate W / Olmesartan Medoxomil; Diltiazem HCL



Possible Tekturna HCT side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: male

Reactions: Asthma, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2011-12-20

Patient: 70 year old female

Reactions: Mood Altered, Mental Status Changes, Depression, Umbilical Hernia, Crying

Drug(s) suspected as cause:
Tekturna HCT

Other drugs received by patient: Lisinopril; Fenofibrate; Hydrochlorothiazide; Metoprolol Succinate; Vitamin D; Estrace; Oxaprozin; Sertraline Hydrochloride



Possible Tekturna HCT side effects in female

Reported by a individual with unspecified qualification from United States on 2011-12-20

Patient: female

Reactions: Blood Pressure Increased, Drug Effect Decreased, Pain, Tachycardia, Headache, Malaise, Memory Impairment, Feeling Abnormal, Blood Pressure Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tekturna HCT

Other drugs received by patient: Acetaminophen; Naproxen; Flexeril; Gabapentin; Lorazepam; Keppra; Amoxicilina; Prednisone TAB



Possible Tekturna HCT side effects in female

Reported by a physician from United States on 2011-12-20

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Diabetes Mellitus Inadequate Control

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in 87 year old female

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 87 year old female

Reactions: Humerus Fracture, Wrist Fracture, Fall

Drug(s) suspected as cause:
Tekturna HCT

Other drugs received by patient: Acetaminophen; Vitamins NOS; Metoprolol; Metolazone



Possible Tekturna HCT side effects in female

Reported by a individual with unspecified qualification from United States on 2011-12-01

Patient: female, weighing 157.0 kg (345.4 pounds)

Reactions: Dyspnoea, Head Injury, Somnolence, Loss of Consciousness, Speech Disorder, Fatigue, Malaise, Diarrhoea, Dizziness, Vision Blurred, Gait Disturbance, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Tekturna HCT
    Dosage: 300/12.5 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-11-01
    End date: 2011-11-07

Tekturna HCT
    Dosage: 150/12.5 mg, qd
    Administration route: Oral
    Start date: 2011-11-07

Other drugs received by patient: Lasix; Furosemide; Aspirin; Vitamin TAB; Tramadol HCL; Calcium Carbonate; Multivitamin; Lasix



Possible Tekturna HCT side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2011-11-30

Patient: 65 year old female

Reactions: Nausea, Blood Pressure Inadequately Controlled, Dizziness, Feeling Abnormal, Hypertension

Drug(s) suspected as cause:
Tekturna
    Dosage: 150 mg (1 in the night),oral ; 150 mg ,oral
    Administration route: Oral
    Start date: 2011-01-01

Tekturna HCT
    Dosage: 150 mg of alisk and 12.5 mg (1 in the morning), oral ; oral
    Administration route: Oral
    Start date: 2011-01-01

Other drugs received by patient: Toprol-XL



Possible Tekturna HCT side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2011-11-30

Patient: 65 year old female

Reactions: Nausea, Heart Rate Increased, Blood Pressure Inadequately Controlled, Dizziness, Hypertension, Feeling Abnormal

Drug(s) suspected as cause:
Tekturna HCT
    Dosage: 150 mg of alisk and 12.5 mg (1 in the morning),oral ; oral
    Administration route: Oral
    Start date: 2011-01-01

Tekturna
    Dosage: 150 mg (1 in the night),oral ; 150 mg, oral
    Administration route: Oral
    End date: 2011-01-01

Other drugs received by patient: Toprol-XL



Possible Tekturna HCT side effects in female

Reported by a physician from United States on 2011-11-25

Patient: female

Reactions: Osteoarthritis, Autoimmune Disorder, Diabetes Mellitus, Osteoporosis, Sleep Disorder, Thyroid Disorder, Headache, Cardiac Disorder

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2011-11-21

Patient: 52 year old female, weighing 149.7 kg (329.3 pounds)

Reactions: Product Quality Issue, Dyspnoea, Oedema Peripheral

Drug(s) suspected as cause:
Tekturna HCT



Possible Tekturna HCT side effects in female

Reported by a individual with unspecified qualification from United States on 2011-11-15

Patient: female

Reactions: Diabetes Mellitus, Osteoporosis, Headache, Cardiac Disorder, Osteoarthritis, Autoimmune Disorder, Sleep Disorder, Thyroid Disorder

Drug(s) suspected as cause:
Tekturna HCT

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