Aliskiren / hydrochlorothiazide Side Effects

Not all side effects for aliskiren / hydrochlorothiazide may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aliskiren / hydrochlorothiazide: oral tablet

In addition to its needed effects, some unwanted effects may be caused by aliskiren / hydrochlorothiazide. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking aliskiren / hydrochlorothiazide:

Less common
  • Chills
  • cough
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • runny nose
  • shivering
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
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

If any of the following symptoms of overdose occur while taking aliskiren / hydrochlorothiazide, get emergency help immediately:

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 of the side effects that can occur with aliskiren / hydrochlorothiazide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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)

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.

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