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Tekturna (Aliskiren) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tekturna (Aliskiren) 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 (233)
Death (9)
Life Threatening Events (9)
Disability (10)

Reports by Reaction Type

Blood Pressure Increased (33)Hypertension (27)Drug Ineffective (21)Dizziness (21)Cerebrovascular Accident (19)Diabetes Mellitus (16)Rash (15)Blood Pressure Inadequately Controlled (14)Diarrhoea (13)Blood Pressure Fluctuation (13)Pruritus (12)Fatigue (12)

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

Possible Tekturna side effects in 79 year old female

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

Patient: 79 year old female

Reactions: Abdominal Pain, Agitation, Pruritus, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Feeling of Body Temperature Change, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Blood Creatine Increased, Tremor, Anxiety, Heart Rate Decreased, Arthralgia, Diarrhoea

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

Cartia XT
    Dosage: unk

Celebrex
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cymbalta
    Dosage: unk

Diltiazem
    Dosage: unk

Diovan
    Dosage: unk

Fentanyl
    Dosage: unk

Levaquin

Macrobid
    Dosage: unk

Micardis
    Dosage: unk

Mirtazapine
    Dosage: unk

Naproxen Sodium
    Dosage: unk

Norvasc
    Dosage: unk

Paxil
    Dosage: unk

Prozac
    Dosage: unk

Tekturna
    Dosage: unk

Tiazac
    Dosage: unk

Toprol-XL

Vasotec
    Dosage: unk

Wellbutrin XL
    Dosage: unk

Zoloft
    Dosage: unk

Other drugs received by patient: Effexor XR; Protonix



Possible Tekturna side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 120.2 kg (264.4 pounds)

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Depo-Testosterone



Possible Tekturna side effects in female

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

Patient: female

Reactions: Vomiting, Renin Increased, Bartter's Syndrome, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Magnesium; Vitamin E; Nortriptyline; Crestor; Potassium; Vitamin B-12



Possible Tekturna side effects in female

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

Patient: female

Reactions: Anxiety, Blood Pressure Inadequately Controlled, Vision Blurred, Myocardial Infarction, Cerebrovascular Accident, Cardiac Disorder, Loss of Consciousness

Drug(s) suspected as cause:
Diovan
    Dosage: 160 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-07-01

Tekturna
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: Blood Pressure
    Start date: 2010-07-01

Other drugs received by patient: Lasix; Paxil; Clonazepam; Potassium



Possible Tekturna side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 124.3 kg (273.4 pounds)

Reactions: Grand MAL Convulsion, Burning Sensation, Road Traffic Accident, Contusion, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Tramadol HCL; Allopurinol; Folic Acid; Bystolic



Possible Tekturna side effects in male

Reported by a physician from Japan on 2012-08-03

Patient: male

Reactions: Asthma, Hyperkalaemia, Cerebral Infarction, Ventricular Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2008-09-18

Aspirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-22

Aspirin
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2011-10-21

Aspirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2011-07-28

Aspirin
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2011-08-10
    End date: 2011-08-18

Coreg
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2008-12-11

Enalapril Maleate
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-01-07
    End date: 2010-03-03

Enalapril Maleate
    Dosage: unk
    Administration route: Oral
    Start date: 2010-03-04
    End date: 2012-02-02

Lasix
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2008-07-22

Lipitor
    Dosage: 10 mg, unk
    Administration route: Oral
    Start date: 2008-07-22

Pulmicort
    Dosage: unk
    Start date: 2011-09-15

Rabeprazole Sodium
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-22

Sigmart
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-22

Slow-K
    Dosage: 600 mg, unk
    Administration route: Oral
    Indication: Hypokalaemia
    Start date: 2010-09-16

Tekturna
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2010-02-18
    End date: 2010-03-03

Tekturna
    Dosage: unk
    Administration route: Oral
    Start date: 2010-03-04
    End date: 2012-02-02

Warfarin Sodium
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2011-08-10
    End date: 2011-08-21

Warfarin Sodium
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2011-04-28
    End date: 2011-08-03

Warfarin Sodium
    Dosage: 3.25 mg, unk
    Administration route: Oral
    Start date: 2011-09-16

Warfarin Sodium
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2011-08-27
    End date: 2011-09-05



Possible Tekturna side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Tekturna



Possible Tekturna side effects in 40 year old

Reported by a physician from United States on 2012-07-17

Patient: 40 year old

Reactions: Convulsion

Drug(s) suspected as cause:
Tekturna



Possible Tekturna side effects in male

Reported by a physician from United States on 2012-07-17

Patient: male, weighing 92.0 kg (202.4 pounds)

Reactions: Basal Ganglia Haemorrhage, Haemorrhagic Stroke

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Norvasc; Januvia; Ticlopidine HCL; Aspirin; Tricor; Lisinopril; Anticoagulants / Antiplatelets



Possible Tekturna side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female

Reactions: Slow Speech, Ischaemic Stroke, Hemiparesis, Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Trilipix; ACE Inhibitors; Bystolic; Plendil; Metformin HCL; Amaryl



Possible Tekturna side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: male

Reactions: Road Traffic Accident, Syncope, Head Injury, Haemorrhage, Drug Ineffective, Vertigo, Blood Pressure Fluctuation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antihypertensives
    Dosage: 1 df, unk
    Indication: Blood Pressure

Benazepril
    Dosage: unk ukn, unk

Diazepam
    Dosage: unk ukn, unk

Diovan
    Dosage: unk ukn, unk

Lisinopril
    Dosage: unk ukn, unk

Tekturna
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Blood Pressure

Valturna
    Dosage: unk ukn, unk

Other drugs received by patient: Hydrocodone Bitartrate; Fish OIL; Cymbalta; Soma; Cymbalta; Hydrocodone Bitartrate; Fentanyl-100; Pravastatin; Carisoprodol; Calcium; Clonazepam; Synthroid; Aspirin; Levothyroxine Sodium; Analgesics



Possible Tekturna side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: male

Reactions: Road Traffic Accident, Syncope, Drug Ineffective, Haemorrhage, Head Injury, Vertigo, Blood Pressure Fluctuation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antihypertensives
    Dosage: 1 df, unk
    Indication: Blood Pressure

Benazepril Hydrochloride
    Dosage: unk ukn, unk

Diazepam
    Dosage: unk ukn, unk

Diovan
    Dosage: unk ukn, unk

Lisinopril
    Dosage: unk ukn, unk

Tekturna
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Blood Pressure

Valturna
    Dosage: unk ukn, unk

Other drugs received by patient: Levothyroxine Sodium; Hydrocodone Bitartrate; Soma; Pravastatin; Aspirin; Fentanyl-100; Carisoprodol; Cymbalta; Fish OIL; Clonazepam; Synthroid; Cymbalta; Analgesics; Hydrocodone Bitartrate; Calcium



Possible Tekturna side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Tekturna
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Hypertension

Tekturna
    Indication: Protein Urine



Possible Tekturna side effects in 40 year old male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 40 year old male, weighing 69.4 kg (152.7 pounds)

Reactions: Migraine, Blood Pressure Increased, Blood Cortisol Increased, Blood Catecholamines Decreased, Mydriasis, Restlessness, Condition Aggravated, Urine Calcium Increased, Temporomandibular Joint Syndrome, Syncope, Norepinephrine Increased, Blood Corticotrophin Abnormal, Decreased Appetite

Drug(s) suspected as cause:
Clonidine HCL
    Indication: Blood Pressure Increased

Cymbalta
    Dosage: 30 mg daily, 60 mg daily, 80 mg daily, 120 mg daily, 6-8 years ago
    Indication: Anxiety
    Start date: 2012-04-01

Cymbalta
    Dosage: 30 mg daily, 60 mg daily, 80 mg daily, 120 mg daily, 6-8 years ago
    Indication: Blood Pressure Increased
    Start date: 2012-04-01

Cymbalta
    Dosage: 30 mg daily, 60 mg daily, 80 mg daily, 120 mg daily, 6-8 years ago
    Indication: Pain
    Start date: 2012-04-01

Cymbalta
    Dosage: 30 mg daily, 60 mg daily, 80 mg daily, 120 mg daily, 6-8 years ago
    Indication: Anxiety
    End date: 2012-03-01

Cymbalta
    Dosage: 30 mg daily, 60 mg daily, 80 mg daily, 120 mg daily, 6-8 years ago
    Indication: Blood Pressure Increased
    End date: 2012-03-01

Cymbalta
    Dosage: 30 mg daily, 60 mg daily, 80 mg daily, 120 mg daily, 6-8 years ago
    Indication: Pain
    End date: 2012-03-01

Effexor
    Dosage: 75 mg daily
    Indication: Depression
    Start date: 2012-04-01

Exforge
    Indication: Blood Pressure Increased

Hydrochlorothiazide
    Indication: Blood Pressure Increased

Tekturna
    Indication: Blood Pressure Increased

Other drugs received by patient: Oxycodone HCL; Lipitor; Alprazolam; Flexeril; Floricet (Acetaminophen, Butalbital, and Caffeine); Soma



Possible Tekturna side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 63 year old male, weighing 102.1 kg (224.5 pounds)

Reactions: Dyspnoea, Feeling Abnormal

Drug(s) suspected as cause:
Tekturna



Possible Tekturna side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 86 year old female

Reactions: Movement Disorder, Head Discomfort, Lymphadenopathy, Abasia, Pain, Paralysis, Myalgia, Malaise, Palpitations, Musculoskeletal Stiffness, Dizziness, Muscular Weakness, Hypoaesthesia, Dysstasia, Gait Disturbance, Feeling Abnormal, Asthenia, Hypertension

Drug(s) suspected as cause:
Avapro

Cozaar
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-05-10

Cozaar
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-10-01
    End date: 2009-01-01

Cozaar
    Administration route: Oral
    Start date: 2011-04-01

Micardis

Tekturna

Other drugs received by patient: Sular; Plavix



Possible Tekturna side effects in male

Reported by a physician from United States on 2012-06-15

Patient: male

Reactions: Renal Impairment, Diabetes Mellitus

Drug(s) suspected as cause:
Tekturna



Possible Tekturna side effects in 86 year old female

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 86 year old female

Reactions: Movement Disorder, Lymphadenopathy, Head Discomfort, Pain, Abasia, Paralysis, Myalgia, Malaise, Palpitations, Dizziness, Musculoskeletal Stiffness, Muscular Weakness, Hypoaesthesia, Dysstasia, Gait Disturbance, Feeling Abnormal, Hypertension, Asthenia

Drug(s) suspected as cause:
Avapro

Cozaar
    Administration route: Oral
    Start date: 2011-04-01

Cozaar
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-10-01
    End date: 2009-01-01

Cozaar
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-05-10

Micardis

Tekturna

Other drugs received by patient: Plavix; Sular



Possible Tekturna side effects in female

Reported by a physician from United States on 2012-06-12

Patient: female, weighing 98.0 kg (215.6 pounds)

Reactions: Blood Potassium Increased, Cerebrovascular Accident

Drug(s) suspected as cause:
Enalapril Maleate
    Dosage: 20 mg, bid
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-10-01

Tekturna
    Dosage: 300 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-07-01
    End date: 2011-10-01

Other drugs received by patient: Hydrochlorothiazide; Humalog; Norvasc; Welchol



Possible Tekturna side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: female

Reactions: Breast Cancer, Arthritis

Drug(s) suspected as cause:
Diovan
    Dosage: 320 mg, unk

Tekturna
    Dosage: 150 mg, unk



Possible Tekturna side effects in 80 year old male

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: 80 year old male

Reactions: Syncope, Renal Impairment, Blood Sodium Decreased

Adverse event resulted in: hospitalization

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

Tekturna
    Dosage: unk ukn, unk



Possible Tekturna side effects in male

Reported by a physician from United States on 2012-05-30

Patient: male

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tekturna



Possible Tekturna side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: 60 year old male, weighing 97.5 kg (214.6 pounds)

Reactions: Renal Failure

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Quinapril
    Dosage: 40mg daily p.o.
    Administration route: Oral

Tekturna
    Dosage: 150mg daily p.o.
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 2010-05-01
    End date: 2010-09-01



Possible Tekturna side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: female

Reactions: Vascular Injury, Pain in Extremity, Discomfort

Drug(s) suspected as cause:
Tekturna



Possible Tekturna side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: male

Reactions: Nephrolithiasis, Renal Failure, Calculus Bladder

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Avodart; Amlodipine Besylate; Lipitor; Flomax



Possible Tekturna side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: male

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Diovan

Tekturna

Valturna



Possible Tekturna side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: female

Reactions: Breast Cancer, Arthritis

Drug(s) suspected as cause:
Diovan
    Dosage: 320 mg, unk

Tekturna
    Dosage: 150 mg, unk



Possible Tekturna side effects in female

Reported by a physician from United States on 2012-05-18

Patient: female

Reactions: Blood Pressure Inadequately Controlled, Transient Ischaemic Attack

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Amlodipine Besylate; Aspirin; Simvastatin; Lisinopril; Lisinopril and Hydrochlorothiazide



Possible Tekturna side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: male

Reactions: Nephrolithiasis, Calculus Bladder

Drug(s) suspected as cause:
Tekturna

Other drugs received by patient: Flomax; Amlodipine Besylate; Lipitor; Avodart



Possible Tekturna side effects in female

Reported by a physician from United States on 2012-05-09

Patient: female, weighing 67.0 kg (147.4 pounds)

Reactions: Hyponatraemia

Drug(s) suspected as cause:
Crizotinib
    Dosage: 250 mg, 2x/day
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-02-04
    End date: 2011-03-08

Diovan
    Dosage: 160 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-02-07
    End date: 2011-03-14

Tekturna
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-05-01

Other drugs received by patient: Synthroid; Estring Hormone; Avapro; Zyrtec; Triamcinolone; Vitamin D; Lorazepam; Folic Acid; Simvastatin; Naproxen (Aleve); CO-Q-10; Calcium with Vitamin D; Mucinex

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