Rentensar Side effects

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What are the possible side effects of Rentensar?

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

In rare cases, Rentensar 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:

Common Rentensar side effects may include:

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 Rentensar in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Undesirable effects in patients receiving Rentensar are generally mild and transient.

Hypertension: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the Rentensar and the placebo groups. Discontinuation due to any clinical or laboratory adverse event was less frequent for Rentensar-treated patients than for placebo-treated patients. The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race or duration of treatment.

Clinical adverse events, regardless of whether attributed to therapy, occurring in ≥1% of hypertensive patients with Rentensar in placebo-controlled trials are presented in the following table.

Adverse events occurred with similar frequency in placebo- and Rentensar-treated patients, with the exception of headache, musculoskeletal trauma and flushing. Headache occurred significantly more often in the placebo group. Musculoskeletal trauma of differing types and causes occurred with a significantly higher incidence in the Rentensar group; all reports of musculoskeletal trauma were considered unrelated to Rentensar by the investigators. Flushing occurred in 0.6% of Rentensar patients and in no placebo patients. The occurrence of flushing was not related to dose, was not accompanied by other clinical events, and the relationship with Rentensar therapy is unknown.

Hypertension and Type 2 Diabetes with Renal Disease: In a placebo-controlled trial in 590 patients with hypertension, type 2 diabetes, microalbuminuria and normal renal function (IRMA 2), the most relevant adverse reactions reported were dizziness, orthostatic dizziness and orthostatic hypotension. Dizziness was reported by 2.5% or Rentensar 300-mg treated subjects, whereas both orthostatic dizziness and orthostatic hypotension were reported by 0.5% of these subjects. There were no discontinuation due to these adverse reactions. In another placebo-controlled trial in 1715 patients with hypertension, type 2 diabetes, proteinuria ≥900 mg/day and serum creatinine ranging from 1-3 mg/dL (IDNT), the adverse reactions were similar to those seen in patients with uncomplicated hypertension with the exception of orthostatic symptoms. In IDNT, orthostatic symptoms occurred more frequently in the Rentensar group than in the placebo group. Dizziness was reported in 10.2% of the patients in the Rentensar group and in 6% of the patients in the placebo group. Orthostatic dizziness was reported in 5.4% and 2.7% of the patients in the Rentensar and placebo groups, respectively; and orthostatic hypertension was reported in 5.4% and 3.2% of the patients in the Rentensar and placebo groups, respectively. The rates of discontinuation for orthostatic symptoms in IDNT were: 0.3% and 0.5% for dizziness in the Rentensar and placebo groups, respectively; and 0.2% and 0% for orthostatic dizziness in the Rentensar and placebo groups, respectively. No patients in IDNT were discontinued due to orthostatic hypotension.

Laboratory Test Parameters: Hypertension: Although significant increases in plasma creatine kinase occurred more frequently in Rentensar-treated subjects (1.7% vs 0.7% in placebo-treated subjects), none of these increases were classified as serious, resulted in drug discontinuation, or were associated with identifiable clinical musculoskeletal events. No special monitoring of laboratory parameters is necessary for patients with essential hypertension receiving therapy with Rentensar, when the renal function is normal.

Hypertension with Type 2 Diabetes and Renal Disease: In clinical trials conducted in patients with diabetic renal disease, the laboratory test parameter profile was similar to that of hypertension, with the exception of hyperkalemia. In a placebo-controlled trial in 590 patients with hypertension, type 2 diabetes, microalbuminuria and normal renal function (IRMA 2), hyperkalemia ≥5.5 mEq/L occurred in 29.4% of the patients in the Rentensar 300-mg group and 22% of the patients in the placebo group. Discontinuation of hyperkalemia occurred in 0.5% of the patients in the Rentensar group.

In another placebo-controlled trial in 1715 patients with hypotension, type 2 diabetes, proteinuria ≥900 mg/day and serum creatinine ranging from 1-3 mg/dL (IDNT), hyperkalemia ≥5.5 mEq/L occurred in 46.3% of the patients in the Rentensar group and 26.3% of the patients in the placebo group. Discontinuation for hyperkalemia occurred in 2.1% and 0.4% of the patients in the Rentensar and placebo groups, respectively.

Post-Marketing Experience: As with other angiotensin II receptor antagonists, rare cases of hypersensitivity reactions (rash, urticaria, angioedema) have been reported.

Cases of cough have been reported very rarely with Rentensar. The following have also been reported very rarely during post-marketing surveillance:

Metabolism and Nutrition Disorders: Hyperkalemia.

Nervous System Disorders: Dizziness, headache.

Ear and Labyrinth Disorders: Tinnitus.

Cardiac Disorders: Tachycardia.

Gastrointestinal Disorders: Diarrhoea, dyspepsia, nausea.

Hepatobiliary Disorders: Abnormal liver function, hepatitis.

Musculoskeletal, Connective Tissue and Bone Disorders: Myalgia, arthralgia.

Renal and Urinary Disorders: Impaired renal function including isolated cases of renal failure in patients at risk.

General Disorders and Administration Site Conditions: Asthenia.

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

Rentensar contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Hypersensitivity to any component of Rentensar.

Use in pregnancy: The use of angiotensin-II receptor antagonists (AIIRAs) is not recommended during the 1st trimester of pregnancy and contraindicated during the 2nd and 3rd trimesters of pregnancy.

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the 1st trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs. Unless continued, AIIRA therapy is considered essential. Patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and if appropriate, alternative therapy should be started.

AIIRA therapy exposure during the 2nd and 3rd trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

Should exposure to AIIRAs occur from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken AIIRAs should be closely observed for hypotension.

Use in lactation: Because no information is available regarding the use of Rentensar during breastfeeding, Rentensar is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or pre-term infant. It is unknown whether Rentensar or its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in rats have shown excretion of Rentensar or its metabolites in milk.

Use in fertility: Rentensar had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the 1st signs of parenteral toxicity.



  1. DailyMed. "IRBESARTAN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". (accessed September 17, 2018).
  2. DTP/NCI. "irbesartan: 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.". (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "2-butyl-3-({4-[2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1,3-diazaspiro[4.4]non-1-en-4-one: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". (accessed September 17, 2018).


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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