Note: This document contains side effect information about aliskiren / amlodipine / hydrochlorothiazide. Some dosage forms listed on this page may not apply to the brand name Amturnide.
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]
