Omen(MEDLEY) Side effects

• Side effects of Omen(MEDLEY) in details
• Omen(MEDLEY) contraindications
• Omen(MEDLEY) reviews

What are the possible side effects of Omen(MEDLEY)?

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urinating;

• severe or ongoing diarrhea with weight loss;

• chest pain, fast heart rate; or

• swelling in your hands or feet.

Common Omen(MEDLEY) side effects may include:

• dizziness.

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.

Side effects of Omen(MEDLEY) in details

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.

Adult Hypertension

Omen(MEDLEY) 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 for at least 1 year. Treatment with Omen(MEDLEY) was well tolerated, with an incidence of adverse reactions similar to placebo. Events generally were mild, transient and had no relationship to the dose of Omen(MEDLEY).

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

The following adverse reactions occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with Omen(MEDLEY), but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.

The incidence of cough was similar in placebo (0.7%) and Omen(MEDLEY) (0.9%) patients.

Other potentially important adverse reactions that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in the more than 3100 hypertensive patients treated with Omen(MEDLEY) monotherapy in controlled or open-label trials are listed below.

Body as a Whole: chest pain, peripheral edema

Central and Peripheral Nervous System: vertigo

Gastrointestinal: abdominal pain, dyspepsia, gastroenteritis, nausea

Heart Rate and Rhythm Disorders: tachycardia

Metabolic and Nutritional Disorders: hypercholesterolemia, hyperlipemia, hyperuricemia

Musculoskeletal: arthralgia, arthritis, myalgia

Skin and Appendages: rash

Facial edema was reported in five patients receiving Omen(MEDLEY). Angioedema has been reported with angiotensin II antagonists.

Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Omen(MEDLEY).

Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.

Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to Omen(MEDLEY) and one patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the five Omen(MEDLEY) patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.

Pediatric Hypertension

No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to16 years and that previously reported for adult patients.

Post-Marketing Experience

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

Body as a Whole: Asthenia, angioedema, anaphylactic reactions

Gastrointestinal: Vomiting, sprue-like enteropathy

Metabolic and Nutritional Disorders: Hyperkalemia

Musculoskeletal: Rhabdomyolysis

Urogenital System: Acute renal failure, increased blood creatinine levels

Skin and Appendages: Alopecia, pruritus, urticaria

Data from one controlled trial and an epidemiologic study have suggested that high-dose Omen(MEDLEY) may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Omen(MEDLEY) And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of Omen(MEDLEY), 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, delayed onset of microalbuminuria, but Omen(MEDLEY) 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 Omen(MEDLEY) group compared to the placebo group (15 Omen(MEDLEY) vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with Omen(MEDLEY) (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 Omen(MEDLEY) (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 Omen(MEDLEY) 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 Omen(MEDLEY) 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 Omen(MEDLEY) 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.

What is the most important information I should know about Omen(MEDLEY)?

• Omen(MEDLEY) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Omen(MEDLEY) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Omen(MEDLEY) may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Omen(MEDLEY) may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
• Omen(MEDLEY) may not work as well in black patients. Discuss any questions or concerns with your doctor.
• Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.
• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• Tell your doctor or dentist that you take Omen(MEDLEY) before you receive any medical or dental care, emergency care, or surgery.
• A certain bowel problem has happened in some patients taking Omen(MEDLEY). This has happened within months to years after Omen(MEDLEY) was started. Contact your doctor right away if you experience severe or persistent diarrhea, or sudden or unexplained weight loss.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
• Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Omen(MEDLEY). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Omen(MEDLEY) should not be used in CHILDREN younger than 1 year old; it may affect kidney development in these children.
• PREGNANCY and BREAST-FEEDING: Omen(MEDLEY) may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Omen(MEDLEY) is found in breast milk. Do not breast-feed while taking Omen(MEDLEY).

Omen(MEDLEY) contraindications

Stop using this medication and tell your doctor right away if you become pregnant. Omen(MEDLEY) can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not use this medication if you are allergic to Omen(MEDLEY).

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Omen(MEDLEY).

Do not use potassium supplements or salt substitutes while you are taking Omen(MEDLEY), unless your doctor has told you to.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

References

1. DTP/NCI. "Olmesartan: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "Olmesartan". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Omen(MEDLEY) are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Omen(MEDLEY). We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

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Information checked by Dr. Sachin Kumar, MD Pharmacology