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Aliskiren / hydrochlorothiazide Side Effects

For the Consumer

Applies to aliskiren / hydrochlorothiazide: oral tablet

Along with its needed effects, aliskiren/hydrochlorothiazide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aliskiren / hydrochlorothiazide:

Less Common

Incidence Not Known

  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest

Get emergency help immediately if any of the following symptoms of overdose occur while taking aliskiren / hydrochlorothiazide:

Symptoms of Overdose

  • Coma
  • confusion
  • decreased urine output
  • drowsiness
  • dry mouth
  • fainting
  • increase in heart rate
  • increased thirst
  • irregular heartbeat
  • irritability
  • lightheadedness
  • muscle cramps
  • numbness, tingling, pain, or weakness in the hands or feet
  • rapid breathing
  • seizures
  • sunken eyes
  • swelling of the face, ankles, or hands
  • trembling
  • weak pulse
  • weakness and heaviness of the legs
  • wrinkled skin

Some side effects of aliskiren / hydrochlorothiazide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

  • Difficulty with moving
  • feeling of constant movement of self or surroundings
  • lack or loss of strength
  • muscle stiffness
  • sensation of spinning

For Healthcare Professionals

Applies to aliskiren / hydrochlorothiazide: oral tablet

Hypersensitivity

Aliskiren:

Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms

Postmarketing reports: Angioedema

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Anaphylaxis[Ref]

Two cases of angioedema with respiratory symptoms were reported with aliskiren use in clinical studies, and two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of angioedema cases in completed studies was 0.06%. Twenty-six other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including four which led to discontinuation. In the placebo controlled studies, the incidence of edema involving the face, hands or whole body was 0.4% with aliskiren compared with 0.5% with placebo.[Ref]

Metabolic

Frequency not reported: Edema, peripheral edema

Aliskiren:

Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones

Postmarketing reports: Peripheral edema, hyponatremia

Hydrochlorothiazide:

Very common (10% or more): Mild hypokalemia (decrease of 0.5 mEq/L) occurs in up to 50% of patients, and may predispose patients to cardiac arrhythmias

Common (1% to 10%): Metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, elevated serum uric acid levels

Very rare (less than 0.01%): Hot flushes

Frequency not reported: Edema, peripheral edema, glucose intolerance, a potentially deleterious effect on the lipid profile (i.e., increased serum cholesterol)[Ref]

Gastrointestinal

Aliskiren:

Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)

Postmarketing reports: Nausea, vomiting

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Nausea, vomiting, diarrhea[Ref]

In women and the elderly (65 years of age or older) receiving aliskiren therapy, increases in diarrhea rates were evident starting at a dose of 150 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation.[Ref]

Dermatologic

Aliskiren:

Common (1% to 10%): Rash

Rare (less than 0.1%): Angioedema (involving the face, hands, or whole body)

Postmarketing reports: Severe cutaneous adverse reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis)

Hydrochlorothiazide:

Rare (less than 0.1%): Erythema annular centrifugum, acute eczematous dermatitis, morbilliform and leukocytoclastic vasculitis, phototoxic dermatitis

Frequency not reported: Subacute cutaneous lupus erythematosus like reaction[Ref]

Nervous system

Uncommon (0.1% to 1%): Malaise, pain

Frequency not reported: Fatigue

Aliskiren:

Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness

Hydrochlorothiazide:

Frequency not reported: Cerebrovascular insufficiency associated with hydrochlorothiazide-induced plasma volume contraction, cognitive and neurologic impairment (i.e., confusion, somnolence, feeling dazed)- Symptoms resolved following discontinuation of hydrochlorothiazide.[Ref]

Episodes of tonic-clonic seizures were reported in two patients treated with aliskiren in the clinical trials. One patient had predisposing causes for seizures and a negative electroencephalogram (EEG) and cerebral imaging following the seizures (the other patient's EEG and imaging results were not reported). Aliskiren was discontinued and there was no rechallenge.[Ref]

Hepatic

Common (1% to 10%): Occasional elevations (greater than 150% from baseline) in ALT (SGPT)

Hydrochlorothiazide:

Rare (less than 0.1%): Interstitial nephritis[Ref]

Renal

Hydrochlorothiazide:

Rare (less than 0.1%): Renal insufficiency, renal failure, renal dysfunction, interstitial nephritis[Ref]

Hematologic

Hydrochlorothiazide:

Rare (less than 0.1%): Immune-complex hemolytic anemia, aplastic anemia, thrombocytopenia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Asthenia, rigors

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Myalgias, chills, muscle spasms, preservation of mineral bone density in older patients[Ref]

Ocular

Hydrochlorothiazide:

Frequency not reported: Transient blurred vision, acute transient myopia, acute angle-closure glaucoma, xanthopsia[Ref]

Respiratory

Aliskiren:

Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough

Hydrochlorothiazide:

Frequency not reported: Acute noncardiogenic pulmonary edema (these cases are thought to be due to idiosyncrasy or a hypersensitivity mechanism)[Ref]

Other

Rare (less than 0.1%): Parosmia

Frequency not reported: Tinnitus[Ref]

Immunologic

Hydrochlorothiazide:

Common (1% to 10%): Rash that is histologically identical to subacute cutaneous lupus

Frequency not reported: Allergic vasculitis, hemolytic anemia

Cardiovascular

Aliskiren:

Rare (less than 0.1%): Hypotension

Hydrochlorothiazide:

Frequency not reported: Cardiac arrhythmias (including ventricular ectopy and complete AV heart block), hypotension, orthostatic hypotension (more common in the elderly)[Ref]

References

1. "Product Information. Tekturna HCT (aliskiren-hydrochlorothiazide)." Novartis Pharmaceuticals, East Hanover, NJ.

2. "Product Information. Tekturna (aliskiren)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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