What are the possible side effects of Rosufid?
Get emergency medical help if you have any signs of an allergic reaction to Rosufid: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, Rosufid 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.
Also call your doctor at once if you have:
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confusion, memory problems;
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.
Common Rosufid side effects may include:
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liver symptoms (stomach pain, dark urine, jaundice);
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unusual weakness or tired feeling;
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headache, muscle aches; or
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nausea, upset stomach.
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 Rosufid in details
Rosufid is generally well tolerated. The adverse events seen with Rosufid are generally mild and transient. In controlled clinical trials less than 4% of Rosufid treated patients were withdrawn due to adverse events. This withdrawal rate was comparable to that reported in patients receiving placebo.
Common (≥1/100, <1/10): Headache, myalgia, asthenia, constipation, dizziness, nausea, abdominal pain, diabetes mellitus*.
Uncommon (≥1/1000, <1/100): Pruritus, rash and urticaria.
Rare (≥1/10,000, <1/1000): Myopathy (including myositis), hypersensitivity reactions (including angioedema), rhabdomyolysis, pancreatitis.
*Observed in the JUPITER study (reported overall frequency 2.8% in Rosufid and 2.3% in placebo) primarily in patients already at high risk for developing diabetes.
As with other HMG CoA reductase inhibitors, the incidence of adverse drug reactions tends to increase with increasing dose.
Skeletal Muscle Effects: Rare cases of rhabdomyolysis, which were occasionally associated with impairment of renal function, have been reported with Rosufid and with other marketed statins.
Laboratory Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in liver transaminases and CK has been observed in a small number of patients taking Rosufid. Increases in HbA1c have also been observed in patients treated with Rosufid. Abnormal urinalysis testing (dipstick-positive proteinuria) has been seen in a small number of patients taking Rosufid and other HMG-CoA reductase inhibitors. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and is not predictive of acute or progressive renal disease.
Other Effects: In a long-term controlled clinical trial Rosufid was shown to have no harmful effects on the ocular lens.
In Rosufid treated patients, there was no impairment of adrenocortical function.
Post Marketing Experience: In addition to the previously mentioned effects, the following adverse events have been reported during post marketing experience of Rosufid: Haematological Disorders: Frequency Unknown: Thrombocytopenia.
Hepatobiliary Disorders: Very Rare: Jaundice, hepatitis. Rare: Increased hepatic transaminases.
Musculoskeletal Disorder: Frequency Unknown: Immune-mediated necrotising myopathy. Very Rare: Arthralgia.
As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.
Nervous System Disorder: Very Rare: Memory loss. Frequency Unknown: Peripheral neuropathy.
Psychiatric Disorders: Frequency Unknown: Depression, sleep disorders (including insomnia and nightmares).
Reproductive System and Breast Disorders: Frequency Unknown: Gynaecomastia.
Children and Adolescents 6 to 17 Years of Age: The safety profile of Rosufid is similar in children or adolescent patients and adults although CK elevations >10 x ULN and muscle symptoms following exercise or increased physical activity, which resolved with continued treatment, were observed more frequently in clinical trial of children and adolescents. However, the same special warnings and special precautions for use in adults also apply to children and adolescents.
What is the most important information I should know about Rosufid?
- Rosufid may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rosufid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Rosufid may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking Rosufid. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Rosufid, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Rosufid. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
- Follow the diet and exercise program given to you by your health care provider.
- Tell your doctor or dentist that you take Rosufid before you receive any medical or dental care, emergency care, or surgery.
- Women who may become pregnant should use effective birth control while taking Rosufid. Check with your doctor if you have questions about using birth control.
- Do NOT take more than the recommended dose without checking with your doctor.
- Muscle problems (myopathy) may occur with Rosufid. The risk of muscle problems may be greater in people who take higher doses of Rosufid, in people 65 years old and older, or in people who have liver or kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin). Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort or if you have muscle problems that persist even after your doctor has told you to stop taking Rosufid.
- Diabetes patients - Rosufid 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 cholesterol levels, liver function, kidney function, and CPK blood levels, may be performed while you use Rosufid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Rosufid with caution in ASIAN patients and in the ELDERLY; they may be more sensitive to its effects, especially serious muscle problems (eg, muscle pain, tenderness, or weakness).
- Rosufid should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Rosufid if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Rosufid is found in breast milk. Do not breast-feed while taking Rosufid.
Rosufid contraindications
Patients with known hypersensitivity to any component of Rosufid. Hypersensitivity reactions including rash, pruritus, urticaria and angioedema have been reported with Rosufid.
Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels.
Use in pregnancy: Pregnancy Category: X.
Rosufid is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy and cholesterol products are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hyperlipidemia therapy.
There are no adequate and well-controlled studies of Rosufid in pregnany women. There have been rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors.
Rosufid may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking Rosufid, the patient should be apprised of the potential risks to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Rosufid may cause fetal harm when administered to pregnant women. Additionally, there is no apparent benefit to therapy during pregnancy and safety in pregnant women has not been established. If the patient becomes pregnant while taking Rosufid, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy.
Use in lactation: It is not known whether Rosufid is excreted in human milk, but a small amount of another drug in this class does pass into breast milk.
Because another drug in this class passes into human milk and because HMG-CoA reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, women who require Rosufid treatment should be advised not to nurse their infants.
References
- DailyMed. "ROSUVASTATIN CALCIUM: 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).
- European Chemicals Agency - ECHA. "7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic 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).
- HSDB. "Rosuvastatin". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Rosufid 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 Rosufid. 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
