In general, treatment with losartan potassium and hydrochlorothiazide was well tolerated. For the most part, adverse experiences have been mild and transient in nature and have not required discontinuation of therapy.
The following adverse events have been reported: asthenia/fatigue, diarrhea, nausea, headache, bronchitis, pharyngitis.
Adverse events were somewhat more frequent in the elderly compared to non-elderly patients.
Superficial peeling of palms and hemolysis were reported in one subject treated with losartan potassium.
With regards to losartan, other adverse experiences that have been reported with losartan, are listed as follows: Body as a whole: chest pain, facial edema, fever, orthostatic effects, syncope.
Cardiovascular: angina pectoris, arrhythmias including atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia and ventricular fibrillation, CVA, hypotension, myocardial infarction, second degree AV block.
Digestive: anorexia, constipation, dental pain, dry mouth, dyspepsia, flatulence, gastritis, vomiting.
General disorders and administration site conditions: malaise.
Musculoskeletal: arm pain, arthralgia, arthritis, fibromyalgia, hip pain, joint swelling, knee pain, leg pain, muscle cramps, muscle weakness, musculoskeletal pain, myalgia, shoulder pain, stiffness.
Nervous System/Psychiatric: anxiety, anxiety disorder, ataxia, confusion, depression, dream abnormality, hypesthesia, insomnia, libido decreased, memory impairment, migraine, nervousness, panic disorder, paresthesia, peripheral neuropathy, sleep disorder, somnolence, tremor, vertigo.
Respiratory: dyspnea, epistaxis, nasal congestion, pharyngeal discomfort, respiratory congestion, rhinitis, sinus disorder.
Skin: alopecia, dermatitis, dry skin, ecchymosis, erythema, flushing, photosensitivity, pruritus, sweating, urticaria.
Special Senses: blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity, taste perversion, tinnitus.
Urogenital: impotence, nocturia, urinary frequency, urinary tract infection.
With Hydrochlorothiazide, adverse experiences that have been reported with hydrochlorothiazide, are listed as follows: Body as a whole: weakness.
Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.
Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema.
Metabolic: hyperglycemia, glycosuria, hyperuricemia.
Musculoskeletal: muscle spasm.
Nervous System/Psychiatric: restlessness.
Renal: renal failure, renal dysfunction, interstitial nephritis.
Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliate dermatitis including toxic epidermal necrolysis.
Special Senses: transient blurred vision, xanthopsia.
Neoplasm benign, malignant and unspecified (incl cysts and polyps): Frequency 'not known': Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma).
Description of selected adverse reactions: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
Cases of cough, including positive re-challenges, have been reported with the use of losartan.