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Cozaar

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Cozaar

Cozaar Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Cozaar (losartan) is an oral drug that belongs to the drug class called angiotensin receptor blockers (ARBs). Cozaar is prescribed for the treatment of hypertension. Side effects of Cozaar include diarrhea, muscle cramps, dizziness, insomnia, and nasal congestion.

Dosing preparations of Cozaar are 25, 50, and 100 mg tablets. Drug interactions with Cozaar may occur with inhibitors of cytochrome P450, potassium- sparing diuretics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Cozaar should not be used during pregnancy, and it is not known whether it is excreted in breast milk.

Our Cozaar 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.

Cozaar in Detail - Patient Information: Side Effects

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

In rare cases, 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.

Call your doctor at once if you have:

  • a feeling that you might pass out;
  • pain or burning when you urinate;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • wheezing, chest pain;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath, urinating less than usual or not at all; or
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

  • cold or flu symptoms such as stuffy nose, sneezing, sore throat, fever;
  • dry cough;
  • muscle cramps;
  • pain in your legs or back;
  • stomach pain, diarrhea;
  • headache, dizziness;
  • tired feeling; or
  • sleep problems (insomnia).

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 Cozaar (Losartan Potassium) »

What is Patient Information Overview?

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

Cozaar 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.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), unusual change in the amount of urine.

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 Cozaar (Losartan Potassium)»

What is Prescribing information?

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

Cozaar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Hypertension

COZAAR has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients were treated for over 6 months and more than 800 for over one year. In general, treatment with COZAAR was well-tolerated. The overall incidence of adverse experiences reported with COZAAR was similar to placebo.

In controlled clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 2.3 percent of patients treated with COZAAR and 3.7 percent of patients given placebo.

The following table of adverse events is based on four 6-to 12-week, placebo-controlled trials involving over 1000 patients on various doses (10-150 mg) of losartan and over 300 patients given placebo. All doses of losartan are grouped because none of the adverse events appeared to have a dose-related frequency. The adverse experiences reported in ≥ 1% of patients treated with COZAAR and more commonly than placebo are shown in the table below.

  Losartan
(n=1075) Incidence %
Placebo
(n=334) Incidence %
Musculoskeletal
  Cramp, muscle 1 0
  Pain, back 2 1
  Pain, leg 1 0
Nervous System/Psychiatric
  Dizziness 3 2
Respiratory
  Congestion, nasal 2 1
  Infection, upper respiratory 8 7
  Sinusitis 1 0

The following adverse events were also reported at a rate of 1% or greater in patients treated with losartan, but were as, or more frequent, in the placebo group: asthenia/fatigue, edema/swelling, abdominal pain, chest pain, nausea, headache, pharyngitis, diarrhea, dyspepsia, myalgia, insomnia, cough, sinus disorder.

Adverse events occurred at about the same rates in men and women, older and younger patients, and Black and non-Black patients.

A patient with known hypersensitivity to aspirin and penicillin, when treated with COZAAR, was withdrawn from study due to swelling of the lips and eyelids and facial rash, reported as angioedema, which returned to normal 5 days after therapy was discontinued.

Superficial peeling of palms and hemolysis were reported in one subject.

In addition to the adverse events above, potentially important events that occurred in at least two patients/subjects exposed to losartan or other adverse events that occurred in < 1% of patients in clinical studies are listed below. It cannot be determined whether these events were causally related to losartan: Body as a Whole: facial edema, fever, orthostatic effects, syncope; Cardiovascular: angina pectoris, second degree AV block, CVA, hypotension, myocardial infarction, arrhythmias including atrial fibrillation, palpitation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation; Digestive: anorexia, constipation, dental pain, dry mouth, flatulence, gastritis, vomiting; Hematologic: anemia; Metabolic: gout; Musculoskeletal: arm pain, hip pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, fibromyalgia, muscle weakness; Nervous System/Psychiatric: anxiety, anxiety disorder, ataxia, confusion, depression, dream abnormality, hypesthesia, decreased libido, memory impairment, migraine, nervousness, paresthesia, peripheral neuropathy, panic disorder, sleep disorder, somnolence, tremor, vertigo; Respiratory: dyspnea, bronchitis, pharyngeal discomfort, epistaxis, rhinitis, respiratory congestion; Skin: alopecia, dermatitis, dry skin, ecchymosis, erythema, flushing, photosensitivity, pruritus, rash, sweating, urticaria; Special Senses: blurred vision, burning/stinging in the eye, conjunctivitis, taste perversion, tinnitus, decrease in visual acuity; Urogenital: impotence, nocturia, urinary frequency, urinary tract infection.

Persistent dry cough (with an incidence of a few percent) 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 below.

Table 6

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.

Pediatric Patients: No relevant differences between the adverse experience profile for pediatric patients and that previously reported for adult patients were identified.

Hypertensive Patients With Left Ventricular Hypertrophy

In the LIFE study, adverse events with COZAAR were similar to those reported previously for patients with hypertension.

Nephropathy In Type 2 Diabetic Patients

In the RENAAL study involving 1513 patients treated with COZAAR or placebo, the overall incidences of reported adverse experiences were similar for the two groups. COZAAR was generally well tolerated as evidenced by a similar incidence of discontinuations due to side effects compared to placebo (19% for COZAAR, 24% for placebo). The adverse experiences, regardless of drug relationship, reported with an incidence of ≥ 4% of patients treated with COZAAR and occurring more commonly than placebo, on a background of conventional antihypertensive therapy, are shown in the table below.

Table 7

  Losartan and Conventional Antihypertensive Therapy Incidence %
(n=751)
Placebo and Conventional Antihypertensive Therapy Incidence %
(n=762)
Body as a Whole
  Asthenia/Fatigue 14 10
  Chest Pain 12 8
  Fever 4 3
  Infection 5 4
  Influenza-like disease 10 9
  Trauma 4 3
Cardiovascular
  Hypotension 7 3
  Orthostatic hypotension 4 1
Digestive
  Diarrhea 15 10
  Dyspepsia 4 3
  Gastritis 5 4
Endocrine
  Diabetic neuropathy 4 3
  Diabetic vascular disease 10 9
Eyes, Ears, Nose and
  Throat 7 5
  Cataract Sinusitis 6 5
Hemic
  Anemia 14 11
Metabolic and Nutrition
  Hyperkalemia 7 3
  Hypoglycemia 14 10
  Weight gain 4 3
Musculoskeletal
  Back pain 12 10
  Leg pain 5 4
  Knee pain 5 4
  Muscular weakness 7 4
Nervous System
  Hypesthesia 5 4
Respiratory
  Bronchitis 10 9
  Cough 11 10
Skin
  Cellulitis 7 6

Postmarketing Experience

The following additional adverse reactions have been reported in postmarketing experience:

Digestive: Hepatitis (reported rarely).

General Disorders and Administration Site Conditions: Malaise.

Hemic: Thrombocytopenia (reported rarely).

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. Anaphylactic reactions have been reported.

Metabolic and Nutrition: Hyperkalemia, hyponatremia have been reported with losartan.

Musculoskeletal: Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Nervous system disorders: Dysgeusia.

Respiratory: Dry cough (see above).

Skin: Erythroderma.

Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of COZAAR.

Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 0.1 percent of patients with essential hypertension treated with COZAAR alone (see PRECAUTIONS, Impaired Renal Function).

Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.11 grams percent and 0.09 volume percent, respectively) occurred frequently in patients treated with COZAAR alone, but were rarely of clinical importance. No patients were discontinued due to anemia.

Liver Function Tests: Occasional elevations of liver enzymes and/or serum bilirubin have occurred. In patients with essential hypertension treated with COZAAR alone, one patient ( < 0.1%) was discontinued due to these laboratory adverse experiences.

Read the entire FDA prescribing information for Cozaar (Losartan Potassium) »

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Cozaar - User Reviews

Cozaar 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 Cozaar 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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