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Tekturna (Aliskiren Hemifumarate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Tekturna® (aliskiren) has been evaluated for safety in more than 6,460 patients, including over 1,740 treated for longer than 6 months, and more than 1,250 for longer than 1 year. In placebo-controlled clinical trials, discontinuation of therapy due to a clinical adverse event, including uncontrolled hypertension occurred in 2.2% of patients treated with Tekturna, vs. 3.5% of patients given placebo.

Two cases of angioedema with respiratory symptoms were reported with aliskiren use in the clinical studies. Two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of these angioedema cases in the completed studies was 0.06%.

In addition, 26 other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including 4 leading to discontinuation.

In the placebo controlled studies, however, the incidence of edema involving the face, hands or whole body was 0.4% with aliskiren compared with 0.5% with placebo. In a long term active control study with aliskiren and HCTZ arms, the incidence of edema involving the face, hand or whole body was 0.4% in both treatment arms.

Aliskiren produces dose-related gastrointestinal (GI) adverse effects. Diarrhea was reported by 2.3% of patients at 300 mg, compared to 1.2% in placebo patients. In women and the elderly (age ≥65) increases in diarrhea rates were evident starting at a dose of 150 mg daily, with rates for these subgroups at 150 mg comparable to those seen at 300 mg for men or younger patients (all rates about 2.0%-2.3%). Other GI symptoms included abdominal pain, dyspepsia, and gastroesophageal reflux, although increased rates for abdominal pain and dyspepsia were distinguished from placebo only at 600 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.

Aliskiren was associated with a slight increase in cough in the placebo-controlled studies (1.1% for any aliskiren use vs. 0.6% for placebo). In active-controlled trials with ACE inhibitor (ramipril, lisinopril) arms, the rates of cough for the aliskiren arms were about one-third to one-half the rates in the ACE inhibitor arms.

Other adverse effects with increased rates for aliskiren compared to placebo included rash (1% vs. 0.3%), elevated uric acid (0.4% vs. 0.1%), gout (0.2% vs. 0.1%), and renal stones (0.2% vs. 0%).

Single episodes of tonic-clonic seizures with loss of consciousness were reported in two patients treated with aliskiren in the clinical trials. One of these patients did have predisposing causes for seizures and had a negative electroencephalogram (EEG) and cerebral imaging following the seizures (for the other patient EEG and imaging results were not reported). Aliskiren was discontinued and there was no rechallenge.

The following adverse events occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with aliskiren, but also occurred at about the same or greater incidence in patients receiving placebo: headache, nasopharyngitis, dizziness, fatigue, upper respiratory tract infection, back pain, and cough.

Clinical Laboratory Findings

In controlled clinical trials, clinically relevant changes in standard laboratory parameters were rarely associated with the administration of Tekturna. In multiple-dose studies in hypertensive patients Tekturna had no clinically important effects on total cholesterol, HDL, fasting triglycerides, fasting glucose, or uric acid.

Blood Urea Nitrogen, Creatinine

Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 7% of patients with essential hypertension treated with Tekturna alone vs. 6% on placebo.

Hem o globin and Hematocrit

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.08 g/dL and 0.16 volume percent, respectively, for all aliskiren monotherapy) were observed. The decreases were dose-related and were 0.24 g/dL and 0.79 volume percent for 600 mg daily. This effect is also seen with other agents acting on the renin angiotensin system, such as angiotensin inhibitors and angiotensin receptor blockers, and may be mediated by reduction of angiotensin II which stimulates erythropoietin production via the AT1 receptor. These decreases led to slight increases in rates of anemia with aliskiren compared to placebo were observed (0.1% for any aliskiren use, 0.3% for aliskiren 600 mg daily, vs. 0% for placebo). No patients discontinued therapy due to anemia.

Serum Potassium

Increases in serum potassium >5.5 meq/L were infrequent in patients with essential hypertension treated with Tekturna alone (0.9% compared to 0.6% with placebo). However, when used in combination with an angiotensin-converting enzyme inhibitor (ACEI) in a diabetic population increases in serum potassium were more frequent (5.5%) and routine monitoring of electrolytes and renal function is indicated in this population.

Serum Uric Acid

Aliskiren monotherapy produced small median increases in serum uric acid levels (about 6 µmol/L) while HCTZ produced larger increases (about 30 µmol/L). The combination of aliskiren with HCTZ appears to be additive (about a 40 µmol/L increase). The increases in uric acid appear to lead to slight increases in uric acid-related AEs: elevated uric acid (0.4% vs. 0.1%), gout (0.2% vs. 0.1%), and renal stones (0.2% vs. 0%).

Creatine Kinase

Increases in creatine kinase of >300% were recorded in about 1% of aliskiren monotherapy patients vs. 0.5% of placebo patients. Five cases of creatine kinase rises, three leading to discontinuation and one diagnosed as subclinical rhabdomyolysis and another as myositis, were reported as adverse events with aliskiren use in the clinical trials. No cases were associated with renal dysfunction.



REPORTS OF SUSPECTED TEKTURNA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Tekturna. The information is not vetted and should not be considered as verified clinical evidence.

Possible Tekturna side effects / adverse reactions in 63 year old female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 63 year old female

Reactions: Back Pain, Renal Disorder, Amnesia, Back Disorder

Suspect drug(s):
Tekturna
    Dosage: 300 mg, qd

Anesthetics
    Dosage: unk

Other drugs received by patient: Hemax; Acetaminop. W/butalbital/caff./codeine Phosp.; Losartan Potassium; Temazepam; Zemplar; Crestor; Pantoprazole; Lovaza; Prorenal; Aspirin; Hydrocodone Bitartrate



Possible Tekturna side effects / adverse reactions in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16

Patient: 79 year old female

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

Suspect drug(s):
Mirtazapine
    Indication: Product Used FOR Unknown Indication

Micardis
    Indication: Product Used FOR Unknown Indication

Cardura
    Indication: Product Used FOR Unknown Indication

Macrobid
    Indication: Product Used FOR Unknown Indication

Prozac
    Indication: Product Used FOR Unknown Indication

Cipro
    Indication: Product Used FOR Unknown Indication

Norvasc
    Indication: Product Used FOR Unknown Indication

Vasotec
    Indication: Product Used FOR Unknown Indication

Diovan
    Indication: Product Used FOR Unknown Indication

Diltiazem
    Indication: Product Used FOR Unknown Indication

Tiazac
    Indication: Product Used FOR Unknown Indication

Zoloft
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Product Used FOR Unknown Indication

Celebrex
    Indication: Product Used FOR Unknown Indication

Fentanyl
    Indication: Product Used FOR Unknown Indication

Naproxen
    Indication: Product Used FOR Unknown Indication

Wellbutrin XL
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication

Tekturna
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Cartia XT
    Indication: Product Used FOR Unknown Indication

Paxil
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Effexor XR; Protonix



Possible Tekturna side effects / adverse reactions in 84 year old female

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

Patient: 84 year old female

Reactions: Hypersensitivity, Nausea, Incorrect Dose Administered, Dizziness

Suspect drug(s):
Tekturna
    Dosage: half the usual dose, oral ; 150 mg, qd
    Administration route: Oral
    Start date: 2011-05-31

Tekturna
    Dosage: half the usual dose, oral ; 150 mg, qd
    Administration route: Oral
    Start date: 2011-05-26

Other drugs received by patient: Azopt; Magnesium (Magnesium); Fish OIL (Fish Oil); Arginine (Arginine); Coq10 (Ubidecarenone); Vitamin B Complex CAP; Vitamin D; Levoxyl; Albuterol Sulfate; Alphagan; Requip FOR RLS; Ascorbic Acid; Grape Seed Extract (Vitis Vinifera Extract); Cyanocobalamin W/folic Acid/pyridoxine (Cyanocobalamin, Folic Acid, PY; Calcium Carbonate



See index of all Tekturna side effect reports >>

Drug label data at the top of this Page last updated: 2008-01-24

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