Aliskiren / amlodipine / hydrochlorothiazide Side Effects

Not all side effects for aliskiren / amlodipine / 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 / 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
  • Dizziness
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)

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

Endocrine

Amlodipine:
Postmarketing reports: Gynecomastia

Gastrointestinal

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

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

Genitourinary

Amlodipine:
Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia
Rare (less than 0.1%): Dysuria, polyuria

Hematologic

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

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

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

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

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

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)

Immunologic

Hydrochlorothiazide:
Common (1% to 10%): Rash that is histologically identical to subacute cutaneous lupus
Frequency not reported: Allergic vasculitis, hemolytic anemia

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.

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

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

Other

Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus

Renal

Amlodipine:
Rare (less than 0.1%): Interstitial nephritis

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

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)

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