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Hyzaar

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Hyzaar




Hyzaar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/9/2015

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). It 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 dizziness or lightheadedness as your body adjusts to the medication, stomach pain, back pain, tired feeling, skin rash, runny or stuffy nose, sore throat, or dry cough.

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 (non-steroidal 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Hyzaar in Detail - Patient Information: Side Effects

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Hyzaar Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, decrease in vision, eye pain, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Hyzaar (Losartan Potassium-Hydrochlorothiazide)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Hyzaar FDA Prescribing Information: Side Effects
(Adverse Reactions)

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-Schönlein 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)

Hyzaar - User Reviews

Hyzaar User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Hyzaar sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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