What are the possible side effects of Losaric?
Get emergency medical help if you have any of these signs of an allergic reaction to Losaric: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, Losaric 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:
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a feeling that you might pass out;
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pain or burning when you urinate;
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pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
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wheezing, chest pain;
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drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
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swelling, weight gain, feeling short of breath, urinating less than usual or not at all; or
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high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).
Common Losaric side effects may include:
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cold or flu symptoms such as stuffy nose, sneezing, sore throat, fever;
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dry cough;
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muscle cramps;
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pain in your legs or back;
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stomach pain, diarrhea;
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headache, dizziness;
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tired feeling; or
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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.
Side effects of Losaric in details
Losaric has been found to be generally well tolerated in controlled clinical trials for hypertension; side effects have usually been mild and transient in nature and have not required discontinuation of therapy. The overall incidence of side effects reported with Losaric was comparable to placebo.
In controlled clinical trials for essential hypertension, dizziness was the only side effect reported as drug related that occurred with an incidence greater than placebo in one percent or more of patients treated with Losaric. In addition, dose-related orthostatic effects were seen in less than one percent of patients. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo.
In these double-blind controlled clinical trials for essential hypertension, the following adverse experiences reported with Losaric occurred in ≥1 percent of patients, regardless of drug relationship:
Losaric was generally well tolerated in a controlled clinical trial in hypertensive patients with left ventricular hypertrophy. The most common drug-related side effects were dizziness, asthenia/fatigue, and vertigo.
In the LIFE study, among patients without diabetes at baseline, there was a lower incidence of new onset diabetes mellitus with Losaric as compared to atenolol (242 patients versus 320 patients, respectively, p<0.001). Because there was no placebo group included in the study, it is not known if this represents a beneficial effect of Losaric or an adverse effect of atenolol.
Losaric was generally well tolerated in a controlled clinical trial in type 2 diabetic patients with proteinuria. The most common drug-related side effects were asthenia/fatigue, dizziness, hypotension and hyperkalemia.
The following additional adverse reactions have been reported in post-marketing experience: Hypersensitivity: Anaphylactic reactions, 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 Losaric; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely.
Gastrointestinal: Hepatitis (reported rarely), liver function abnormalities, vomiting.
General Disorders and Administration Site Conditions: Malaise.
Hematologic: Anemia, thrombocytopenia (reported rarely).
Musculoskeletal: Myalgia, arthralgia.
Nervous System/Psychiatric: Migraine, dysgeusia.
Reproductive System and Breast Disorders: Erectile dysfunction/impotence.
Respiratory: Cough.
Skin: Urticaria, pruritus, erythroderma, photosensitivity.
Laboratory Test Findings: In controlled clinical trials for essential hypertension, clinically important changes in standard laboratory parameters were rarely associated with administration of Losaric. Hyperkalemia (serum potassium >5.5 mEq/L) occurred in 1.5% of patients in the hypertension clinical trials. In a clinical study conducted in type 2 diabetic patients with proteinuria, 9.9% of patients treated with Losaric and 3.4% of patients treated with placebo developed hyperkalemia. Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.
What is the most important information I should know about Losaric?
- Losaric may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Losaric with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Losaric 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.
- Losaric 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.
- Losaric 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 Losaric before you receive any medical or dental care, emergency care, or surgery.
- 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.
- Patients taking Losaric for kidney problems caused by diabetes have developed low blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. Contact your doctor immediately if you experience symptoms of low blood sugar, including fast heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, or fainting.
- Lab tests, including blood pressure, blood electrolyte levels, and kidney and liver function, may be performed while you use Losaric. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Losaric should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Losaric 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 Losaric is found in breast milk. Do not breast-feed while taking Losaric.
Losaric contraindications
Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Losaric can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.
You should not use this medication if you are allergic to Losaric.
Before you use Losaric, tell your doctor about all your other medical conditions and allergies. Also make sure your doctor knows if you are pregnant or breast-feeding. In some cases, you may not be able to use Losaric, or you may need a dose adjustment or special precautions.
Certain other drugs may interact with Losaric or should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.
In rare cases, Losaric 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.
References
- DailyMed. "LOSARTAN POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "losartan: 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).
- European Chemicals Agency - ECHA. "Losartan potassium: 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).
Reviews
The results of a survey conducted on ndrugs.com for Losaric 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 Losaric. 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
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology