Loril Side effects

• Side effects of Loril in details
• Loril contraindications
• Loril reviews

What are the possible side effects of Loril?

Get emergency medical help if you have signs of an allergic reaction to Loril: hives; severe stomach pain, difficult 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;

• fever, sore throat;

• high potassium - nausea, slow or unusual heart rate, weakness, loss of movement;

• kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Loril side effects may include:

• headache, dizziness;

• cough; or

• chest pain.

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 Loril in details

Clinical Trials Experience

Because clinical trials 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.

Hypertension

In clinical trials in patients with hypertension treated with Loril, 5.7% of patients on Loril discontinued with adverse reactions.

The following adverse reactions (events 2% greater on Loril than on placebo) were observed with Loril alone: headache (by 3.8%), dizziness (by 3.5%), and cough (by 2.5%).

Heart Failure

In patients with systolic heart failure treated with Loril for up to four years, 11% discontinued therapy with adverse reactions. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with Loril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.

The following adverse reactions (events 2% greater on Loril than on placebo) were observed with Loril: hypotension (by 3.8%), and chest pain (by 2.1%).

In the two-dose ATLAS trial in heart failure patients, withdrawals due to adverse reactions were not different between the low and high dose groups, either in total number of discontinuation (17-18%) or in rare specific reactions (< 1%). The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group:

Table 1. Dose-related Adverse Drug Reactions: ATLAS trial

	High Dose (n=1568)	Low Dose (n=1596)
Dizziness	19%	12%
Hypotension	11%	7%
Creatinine increased	10%	7%
Hyperkalemia	6%	4%
Syncope	7%	5%

Acute Myocardial Infarction

Patients treated with Loril had a higher incidence of hypotension (by 5.3%) and renal dysfunction (by 1.3%) compared with patients not taking Loril.

Other clinical adverse reactions occurring in 1% or higher of patients with hypertension or heart failure treated with Loril in controlled clinical trials and do not appear in other sections of labeling are listed below:

Body as a whole: Fatigue, asthenia, orthostatic effects.

Digestive: Pancreatitis, constipation, flatulence, dry mouth, diarrhea.

Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.

Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion.

Metabolic: Gout.

Skin: Urticaria, alopecia, photosensitivity, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens - Johnson syndrome, and pruritus.

Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances, olfactory disturbance.

Urogenital: Impotence.

Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, leukocytosis, paresthesia and vertigo. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.

Clinical Laboratory Test Findings

Serum Potassium: In clinical trials hyperkalemia (serum potassium greater than 5.7 mEq/L) occurred in 2.2% and 4.8% of Loril-treated patients with hypertension and heart failure, respectively.

Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with Loril alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis. Reversible minor increases in blood urea nitrogen and serum creatinine were observed in 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.

Patients with acute myocardial infarction in the GISSI-3 trial treated with Loril had a higher (2.4% versus 1.1% in placebo) incidence of renal dysfunction in-hospital and at six weeks (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration).

Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with Loril but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of Loril that are not included in other sections of labeling. 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.

Other Reactions Include

Metabolism and Nutrition Disorders

Hyponatremia, cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin.

Nervous System and Psychiatric Disorders

Mood alterations (including depressive symptoms), mental confusion, hallucinations

Skin and Subcutaneous Tissue Disorders

Psoriasis

What is the most important information I should know about Loril?

• Loril may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Loril with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Loril 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.
• Loril may cause a serious side effect called angioedema. The risk may be higher in black patients. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
• Severe and sometimes fatal liver problems have happened with Loril. Discuss any questions or concerns with your doctor.
• Loril may not work as well in black patients. Contact your doctor if your symptoms do not improve or if they become worse.
• Loril may cause a dry, unproductive cough. If caused by Loril, this symptom usually stops after treatment with Loril is stopped.
• 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 Loril 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.
• Diabetes patients - Loril may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including blood pressure, blood electrolyte levels, heart function, or kidney or liver function, may be performed while you use Loril. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Loril with caution in the ELDERLY; they may be more sensitive to its effects.
• Loril 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: Loril 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 Loril is found in breast milk. Do not breast-feed while taking Loril.

Loril contraindications

Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking cisapride with other drugs that inhibit cytochrome P450 3A4. Some of these events have been fatal. Concomitant oral or intravenous administration of the following drugs with cisapride may lead to elevated cisapride blood levels and is contraindicated. Antibiotics:

Oral or IV erythromycin, clarithromycin (Biaxin), troleandomycin (TAO). Antidepressants: Nefazodone (Serzone). Antifungals:

Oral or IV fluconazole (Diflucan), itraconazole (Sporanox), oral ketoconazole (Nizoral). Protease Inhibitors: Indinavir (Crixivan), ritonavir (Norvir).Loril is Also Contraindicated for Patients With: History of prolonged electrocardiographic QT intervals or known family history of congenital long QT syndrome; renal failure; history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; clinically significant bradycardia; uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); respiratory failure; and concomitant medications known to prolong the QT interval and increase the risk of arrhythmia, such as certain antiarrhythmics, certain antipsychotics, certain antidepressants, astemizole, bepridil, sparfloxacin, and terodiline. The preceding lists of drugs are not comprehensive. Loril should not be used in patients with uncorrected hypokalemia or hypomagnesemia or who might experience rapid reduction of plasma potassium such as those administered potassium-wasting diuretics and/or insulin in acute settings. Loril should not be used in patients in whom an increase in gastrointestinal motility could be harmful, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Loril is contraindicated in patients with known sensitivity or intolerance to the drug.

References

1. 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).
2. DailyMed. "HYDROCHLOROTHIAZIDE; LISINOPRIL: 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).
3. 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).

Reviews

The results of a survey conducted on ndrugs.com for Loril 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 Loril. 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 reviews

There are no reviews yet. Be the first to write one!

Your name:  Email:  Spam protection:  < Type 28 here

Information checked by Dr. Sachin Kumar, MD Pharmacology