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Aliskiren / amlodipine / hydrochlorothiazide Side Effects

In Summary

Commonly reported side effects of aliskiren/amlodipine/hydrochlorothiazide include: hyperkalemia and hypokalemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to aliskiren / amlodipine / hydrochlorothiazide: oral tablet

Along with its needed effects, aliskiren/amlodipine/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/amlodipine/hydrochlorothiazide:

More Common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

Less Common

Rare

  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness

Incidence Not Known

  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of aliskiren / amlodipine / 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

  • Acid or sour stomach
  • fever
  • headache
  • itching skin
  • lack or loss of strength
  • muscle aches
  • rash
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose

For Healthcare Professionals

Applies to aliskiren / amlodipine / hydrochlorothiazide: oral tablet

Cardiovascular

Aliskiren:

Rare (less than 0.1%): Hypotension

Amlodipine:

Common (1% to 10%): palpitations

Uncommon (0.1% to 1%): Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, vasculitis

Rare (less than 0.1%): Myocardial infarction, angina

Hydrochlorothiazide:

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

Amlodipine:

Common (1% to 10%): Rash, erythematous rash

Uncommon (0.1% to 1%): Angioedema, erythema multiforme, increased sweating, maculopapular rash, pruritus

Rare (less than 0.1%): Alopecia, dermatitis, skin discoloration, skin dryness, urticaria, lichen planus, telangiectasia

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]

Endocrine

Amlodipine:

Postmarketing reports: Gynecomastia[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

Amlodipine:

Common (1% to 10%): Nausea, dysphagia, abdominal pain

Uncommon (0.1% to 1%): Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, vomiting

Rare (less than 0.1%): Gastritis, increased appetite, loose stools, taste perversion, dysgeusia

Hydrochlorothiazide:

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

Genitourinary

Amlodipine:

Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia

Rare (less than 0.1%): Dysuria, polyuria[Ref]

Hematologic

Amlodipine:

Uncommon (0.1% to 1%): Leukopenia, purpura, thrombocytopenia

Hydrochlorothiazide:

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

Hepatic

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

Amlodipine:

Postmarketing reports: Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)-Some cases were severe enough to require hospitalization

Hydrochlorothiazide:

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

Hypersensitivity

Aliskiren:

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

Postmarketing reports: Angioedema

Amlodipine:

Uncommon (0.1% to 1%): Allergic reaction

Hydrochlorothiazide:

Uncommon (0.1% to 1%): Rash

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

Metabolic

Very rare (less than 0.01%): Hot flushes

Frequency not reported: Edema, peripheral edema

Aliskiren:

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

Postmarketing reports: Peripheral edema, hyponatremia

Uric acid increase greater than 50% from baseline was more commonly observed in patients treated with aliskiren / amlodipine / hydrochlorothiazide (4.7%) compared with the dual combinations (0.4 to 2.8%). Gout was less commonly observed (0.3% in aliskiren / amlodipine / hydrochlorothiazide treated patients) and renal stones were not reported.

Amlodipine:

Uncommon (0.1% to 1%): Hyperglycemia, thirst, weight loss, weight gain

Very rare (less than 0.01%): Acute porphyria exacerbation

Frequency not reported: New-onset diabetes

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]

Immunologic

Hydrochlorothiazide:

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

Frequency not reported: Allergic vasculitis, hemolytic anemia[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

Amlodipine:

Common (1% to 10%): Headache, dizziness, somnolence

Uncommon (0.1% to 1%): Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor

Rare (less than 0.1%): Migraine

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]

Musculoskeletal

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

Amlodipine:

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Arthralgia, arthrosis, muscle cramps

Rare (less than 0.1%): Hypertonia, muscle weakness, twitching, ataxia

Hydrochlorothiazide:

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

Ocular

Amlodipine:

Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain

Rare (less than 0.1%): Abnormal visual accommodation, xerophthalmia

Hydrochlorothiazide:

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

Other

Rare (less than 0.1%): Parosmia

Frequency not reported: Tinnitus[Ref]

Renal

Amlodipine:

Rare (less than 0.1%): Interstitial nephritis

Hydrochlorothiazide:

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

Respiratory

Aliskiren:

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

Amlodipine:

Common (1% to 10%): Epistaxis

Uncommon (0.1% to 1%): Dyspnea

Rare (less than 0.1%): Coughing, rhinitis

Postmarketing reports: Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.

Hydrochlorothiazide:

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

References

1. "Product Information. Amturnide (aliskiren / amlodipine / hydrochlorothiazide)." 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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