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Azor

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Azor

Azor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Azor (amlodipine and olmesartan medoxomil) is used to treat high blood pressure (hypertension). Amlodipine is a calcium channel blocker and olmesartan is an angiotensin II receptor antagonist. Common side effects include dizziness or lightheadedness as your body adjusts to the medication. Swelling hands/ankles/feet or flushing may also occur.

The usual starting dose of Azor is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure. Azor may interact with heart medication, potassium supplements or salt substitutes, diuretics (water pills), or other medications that lower blood pressure. Tell your doctor all medications and supplements you use. Azor is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Azor (amlodipine and olmesartan medoxomil) 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.

Azor 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, amlodipine and olmesartan 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.

Also call your doctor at once if you have:

  • a feeling like you might pass out;
  • swelling in your hands or feet, rapid weight gain;
  • pounding heartbeats or fluttering in your chest;
  • urinating less than usual or not at all;
  • jaundice (yellowing of the skin or eyes); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Common side effects include:

  • dizziness, drowsiness;
  • flushing (warmth, redness, or tingly feeling);
  • hair loss; or
  • mild skin rash or itching.

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 Azor (Amlodipine and Olmesartan Medoxomil Tablets) »

What is Patient Information Overview?

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

Azor Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet or flushing may also occur. 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 you have any serious side effects, including: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat),, fast/pounding heartbeat, unusual change in the amount of urine, unusual muscle pain/tenderness, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting, severe/persistent diarrhea.

Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

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 Azor (Amlodipine and Olmesartan Medoxomil Tablets)»

What is Prescribing information?

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

Azor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

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

Azor

The data described below reflect exposure to Azor in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Azor was studied in one placebo-controlled factorial trial (See Clinical Studies). The population had a mean age of 54 years and included approximately 55% males. Seventy-one percent were Caucasian and 25% were Black. Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily.

The overall incidence of adverse reactions on therapy with Azor was similar to that seen with corresponding doses of the individual components of Azor, and to placebo. The reported adverse reactions were generally mild and seldom led to discontinuation of treatment (2.6% for Azor and 6.8% for placebo).

Edema

Edema is a known, dose-dependent adverse effect of amlodipine but not of olmesartan medoxomil.

The placebo-subtracted incidence of edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy. The incidence was significantly reduced when 20 mg or 40 mg of olmesartan medoxomil was added to the 10 mg amlodipine dose.

Placebo-Subtracted Incidence of Edema During the Double-Blind Treatment Period

    Olmesartan Medoxomil
Placebo 20 mg 40 mg
Amlodipine Placebo -* -2.4% 6.2%
5 mg 0.7% 5.7% 6.2%
10 mg 24.5% 13.3% 11.2%
*12.3% = actual placebo incidence

Across all treatment groups, the frequency of edema was generally higher in women than men, as has been observed in previous studies of amlodipine.

Adverse reactions seen at lower rates during the double-blind period also occurred in the patients treated with Azor at about the same or greater incidence as in patients receiving placebo. These included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.

The adverse event profile obtained from 44 weeks of open-label combination therapy with amlodipine plus olmesartan medoxomil was similar to that observed during the 8-week, double-blind, placebo-controlled period.

Initial Therapy

Analyzing the data described above specifically for initial therapy, it was observed that higher doses of Azor caused slightly more hypotension and orthostatic symptoms, but not at the recommended starting dose of Azor 5/20 mg. No increase in the incidence of syncope or near syncope was observed. The incidences of discontinuation because of any treatment emergent adverse events in the double blind phase are summarized in the table below.

Discontinuation for any Treatment Emergent Adverse Event1

    Olmesartan Medoxomil
Placebo 10 mg 20 mg 40 mg
Amlodipine Placebo 4.9% 4.3% 5.6% 3.1%
5 mg 3.7% 0.0% 1.2% 3.7%
10 mg 5.5% 6.8% 2.5% 5.6%
1 Hypertension is counted as treatment failure and not as treatment emergent adverse event. N=160-163 subjects per treatment group.

Amlodipine

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine due to adverse reactions was required in only about 1.5% of amlodipinetreated patients and about 1% of placebo-treated patients. The most common side effects were headache and edema. The incidence (%) of dose-related side effects was as follows:

Adverse Event Placebo
N=520
2.5 mg
N=275
5.0 mg
N=296
10.0 mg
N=268
Edema 0.6 1.8 3.0 10.8
Dizziness 1.5 1.1 3.4 3.4
Flushing 0.0 0.7 1.4 2.6
Palpitation 0.6 0.7 1.4 4.5

For several adverse experiences that appear to be drug-and dose-related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

Adverse Event Placebo Amlodipine
Male=%
(N=914)
Female=%
(N=336)
Male=%
(N=1218)
Female=%
(N=512)
Edema 1.4 5.1 5.6 14.6
Flushing 0.3 0.9 1.5 4.5
Palpitation 0.9 0.9 1.4 3.3
Somnolence 0.8 0.3 1.3 1.6

Olmesartan Medoxomil

Olmesartan medoxomil has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 treated for at least 1 year. Treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse events similar to that seen with placebo. Events were generally mild, transient, and without relationship to the dose of olmesartan medoxomil.

The overall frequency of adverse events was not dose-related. Analysis of gender, age, and race groups demonstrated no differences between olmesartan medoxomil-and placebo-treated patients. The rate of withdrawals due to adverse events in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with olmesartan medoxomil and 2.7% (i.e., 32/1179) of control patients. In placebo-controlled trials, the only adverse event that occurred in more than 1% of patients treated with olmesartan medoxomil and at a higher incidence in olmesartan medoxomil treated patients vs. placebo was dizziness (3% vs 1%).

Post-Marketing Experience

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

Amlodipine

The following post-marketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In post-marketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.

Olmesartan Medoxomil

The following adverse reactions have been reported in post-marketing experience:

Body as a Whole: asthenia, angioedema, anaphylactic reactions, peripheral edema

Gastrointestinal: vomiting, diarrhea, sprue-like enteropathy [see WARNINGS AND PRECAUTIONS]

Musculoskeletal: rhabdomyolysis

Urogenital System: acute renal failure

Skin and Appendages: alopecia, pruritus, urticaria

Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, decrease in time-to-onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18).

The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. In contrast, high-dose olmesartan use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of olmesartan compared to other angiotensin blockers or those receiving therapy for < 6 months.

Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.

Read the entire FDA prescribing information for Azor (Amlodipine and Olmesartan Medoxomil Tablets) »

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Azor - User Reviews

Azor User Reviews

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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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