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Hyzaar

Last reviewed on RxList: 12/26/2015
Hyzaar Side Effects Center

Last reviewed on RxList 9/23/2016

Hyzaar (losartan potassium-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist and a thiazide diuretic (water pill) used to treat high blood pressure (hypertension). Hyzaar is also used to lower the risk of stroke in certain people with heart disease. Hyzaar is available in generic form. Common side effects of Hyzaar include:

Dose of Hyzaar is individualized, and ranges from 50/12.5 (losartan/ hydrochlorothiazide) to 100/25 (losartan/ hydrochlorothiazide). Hyzaar may interact with other blood pressure medications, steroids, lithium, celecoxib, cholestyramine or colestipol, insulin or oral diabetes medications, rifampin, barbiturates, other diuretics, aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs), muscle relaxers, or narcotics. Tell your doctor all medications you use. Hyzaar is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if losartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Our Hyzaar (losartan potassium-hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Hyzaar Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and losartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • eye pain, vision problems;
  • feeling light-headed, fainting;
  • swelling, rapid weight gain;
  • urinating less than usual, or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • fast or pounding heartbeats;
  • pale skin, easy bruising or bleeding;
  • jaundice (yellowing of the skin or eyes); or
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Less serious side effects may include:

  • stomach pain;
  • back pain;
  • dizziness, tired feeling;
  • skin rash;
  • runny or stuffy nose, sore throat; or
  • dry cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hyzaar (Losartan Potassium-Hydrochlorothiazide)

Hyzaar Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Losartan potassium-hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively.

In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% of subjects treated with losartan-hydrochlorothiazide and at a greater rate than placebo were: back pain (2.1% vs 0.6%), dizziness (5.7% vs 2.9%), and upper respiratory infection (6.1% vs 4.6%). The following additional adverse reactions have been reported in clinical trials with HYZAAR and/or the individual components:

Blood and the lymphatic system disorders: Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.

Metabolism and nutrition disorders: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia.

Psychiatric disorders: Insomnia, restlessness.

Nervous system disorders: Dysgeusia, headache, migraine, paraesthesias.

Eye disorders: Xanthopsia, transient blurred vision.

Cardiac disorders: Palpitation, tachycardia.

Vascular disorders: Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders: Nasal congestion, pharyngitis, sinus disorder, respiratory distress (including pneumonitis and pulmonary edema).

Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, diarrhea, constipation, nausea, vomiting, pancreatitis, sialoadenitis.

Hepato-biliary disorders: Jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus.

Musculoskeletal and connective tissue disorders: Muscle cramps, muscle spasm, myalgia, arthralgia.

Renal and urinary disorders: Glycosuria, renal dysfunction, interstitial nephritis, renal failure.

Reproductive system and breast disorders: Erectile dysfunction/impotence.

General disorders and administration site conditions: Chest pain, edema/swelling, malaise, fever, weakness.

Investigations: Liver function abnormalities.

Cough

Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.

Table 1

Study 1* HCTZ Losartan Lisinopril
Cough 25% 17% 69%
Study 2† Placebo Losartan Lisinopril
Cough 35% 29% 62%
* Demographics = (89% Caucasian, 64% female)
† Demographics = (90% Caucasian, 51% female)

These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy.

Cases of cough, including positive re-challenges, have been reported with the use of losartan in postmarketing experience.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of HYZAAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Digestive: Hepatitis has been reported rarely in patients treated with losartan.

Hematologic: Thrombocytopenia.

Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Sch´┐Żnlein purpura, has been reported with losartan. Anaphylactic reactions have been reported.

Musculoskeletal: rhabdomyolysis

Skin: Erythroderma

Read the entire FDA prescribing information for Hyzaar (Losartan Potassium-Hydrochlorothiazide)

Related Resources for Hyzaar

Read the Hyzaar User Reviews »

© Hyzaar Patient Information is supplied by Cerner Multum, Inc. and Hyzaar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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