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 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 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 2012-08-09
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 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 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 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 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 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 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, 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 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 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 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 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 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 2012-06-15
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 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 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 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 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 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 2012-05-18
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 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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