Tareg

Tareg Adverse Reactions

valsartan

Manufacturer:

Sandoz

Distributor:

Sandoz
Full Prescribing Info
Adverse Reactions
In controlled clinical studies in adult patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan. The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed as follows according to system organ class.
Adverse reactions are ranked by frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency an therefore they are mentioned with a "not known" frequency.
Adverse Drug Reactions in Hypertension: Blood and Lymphatic System Disorders: Not Known: Decrease in hemoglobin, decrease in hematocrit, neutropenia, thrombocytopenia.
Immune System Disorders: Not Known: Hypersensitivity including serum sickness.
Metabolism and Nutrition Disorders: Not Known: Increase of serum potassium.
Ear and Labyrinth System Disorders: Uncommon: Vertigo.
Vascular Disorders: Not Known: Vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Cough.
Gastrointestinal Disorders: Uncommon: Abdominal pain.
Hepatobiliary Disorders: Not Known: Elevation of liver function values including increase of serum bilirubin.
Skin and Subcutaneous Tissue Disorders: Not Known: Angioedema, rash, pruritus.
Musculoskeletal and Connective Tissue Disorders: Not Known: Myalgia.
Renal and Urinary Disorders: Not Known: Renal failure and impairment, evaluation of serum creatinine.
General Disorders and Administration Site Conditions: Uncommon: Fatigue.
The following events have also been observed during clinical trials in hypertensive patients irrespective of their causal association with the study drug: Arthralgia, asthenia, back pain, diarrhoea, dizziness, headache, insomnia, libido decrease, nausea, oedema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections.
Hypertensive Adult Patients with Impaired Glucose Tolerance at Cardiovascular Risk: In the NAVIGATOR study, adverse events with valsartan were similar to those reported previously for patients with hypertension.
Pediatric Population (Hypertension): The antihypertensive effect of valsartan has been evaluated in two randomized, double-blind clinical studies in 561 pediatric patients from 6 to 18 years of age. No relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for pediatric patients aged 6 to 18 years and that previously reported for adult patients.
Neurocognitive and developmental assessment of pediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with valsartan for up to one year.
In a double-blind randomized study in 90 children aged 1 to 6 years, which was followed by a one-year open-label extension, two deaths and isolated cases of marked liver transaminases elevations were observed. In a second study in which 75 children aged 1 to 6 years were randomized, no deaths and one case of marked liver transaminase elevations occurred during a one year open-label extension. These cases occurred in a population who has significant comorbidities. A casual relationship to valsartan has not been established.
Hyperkalaemia has been observed in children and adolescents aged 6 to 18 years with underlying chronic kidney disease.
Heart Failure and/or Post-Myocardial Infarction: The safety profile seen in controlled-clinical studies in patients with heart failure and/or post-myocardial infarction varies from the overall safety profile seen in hypertensive patients. This may relate to the patients underlying disease. ADRs that occurred in heart failure and/or post-myocardial infarction patients are listed as follows.
Adverse Drug Reactions in Heart Failure and/or Post-Myocardial Infarction: Blood and Lymphatic System Disorders: Not Known: Thrombocytopenia.
Immune System Disorders: Not Known: Hypersensitivity including serum sickness.
Metabolism and Nutrition Disorders: Uncommon: Hyperkalaemia. Not Known: Increase of serum potassium.
Nervous System Disorders: Common: Dizziness, postural dizziness. Uncommon: Syncope, headache.
Ear and Labyrinth System Disorders: Uncommon: Vertigo.
Cardiac Disorders: Uncommon: Cardiac failure.
Vascular Disorders: Common: Hypotension, orthostatic hypotension. Not Known: Vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Cough.
Gastrointestinal Disorders: Uncommon: Nausea, diarrhea.
Hepatobiliary Disorders: Not Known: Elevation of liver function values.
Skin and Subcutaneous Tissue Disorders: Uncommon: Angioedema. Not Known: Rash, pruritus.
Musculoskeletal and Connective Tissue Disorders: Not Known: Myalgia.
Renal and Urinary Disorders: Common: Renal failure and impairment. Uncommon: Acute renal failure, elevation of serum creatinine. Not Known: Increase in blood urea nitrogen.
General Disorders and Administration Site Conditions: Uncommon: Asthenia, fatigue.
The following events have also been observed during clinical trials in patients with heart failure and/or post-myocardial infarction irrespective of their casual association with the study drug: Arthralgia, abdominal pain, back pain, insomnia, libido decrease, neutropenia, oedema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections.
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