Fenbrat 300 Side effects

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What are the possible side effects of Fenbrat 300?

In rare cases, Fenbrat 300 can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking Fenbrat 300 and 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.

Get emergency medical help if you have any of these signs of an allergic reaction to Fenbrat 300: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking Fenbrat 300 and call your doctor at once if you have any of these other serious side effects:

  • sharp stomach pain spreading to your back or shoulder blade;

  • stomach pain just after eating a meal;

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

  • pain, swelling, warmth, or redness in one or both legs; or

  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious Fenbrat 300 side effects may include:

  • headache, dizziness;

  • back pain;

  • joint pain, mild back pain;

  • diarrhea, upset stomach; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Fenbrat 300 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.
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Clinical studies experience with Fenbrat 300 (fenofibric acid).

Monotherapy: Treatment-emergent adverse events reported in ≥3% of patients treated with Fenbrat 300 during the randomized controlled trials are listed in table.

Co-administration Therapy with Statins (Double-Blind Controlled Trials): Treatment-emergent adverse events reported in ≥3% of patients treated with Fenbrat 300 co-administered with statins during the randomized controlled trials are listed in table.

Co-Administration Therapy with Statins (Long-Term Exposure for up to 64 Weeks): Patients successfully completing any 1 of the 3 double-blind, controlled studies were eligible to participate in a 52-week long-term extension study where they received Fenbrat 300 co-administered with the moderate dose statin. A total of 2201 patients received at least 1 dose of Fenbrat 300 co-administered with a statin in the double-blind controlled study or the long-term extension study for up to a total of 64 weeks of treatment. Additional treatment-emergent adverse events (not listed in table as previously mentioned) reported in ≥3% of patients receiving Fenbrat 300 co-administered with a statin in either the double-blind controlled studies or the long-term extension study are provided as follows: Infections and Infestations: Bronchitis, influenza and urinary tract infection.

Investigations: Increased AST, increased blood CPK and increased hepatic enzyme.

Musculoskeletal and Connective Tissue Disorders: Musculoskeletal pain.

Psychiatric Disorders: Insomnia.

Respiratory, Thoracic and Mediastinal Disorders: Cough and pharyngolaryngeal pain.

Vascular Disorders: Hypertension.

Fenbrat 300: Fenofibric acid is the active metabolite of Fenbrat 300. The following undesirable effects have been observed during placebo-controlled clinical trials using Fenbrat 300 (n=2344) with frequencies: Common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10,000 to <1/1000); very rare (<1/10,000 including isolated reports).

Blood Lymphatic System Disorders: Rare: Decrease haemoglobin and white blood cell count.

Immune System Disorders: Rare: Hypersensitivity.

Nervous System Disorders: Uncommon: Headache.

Vascular Disorders: Uncommon: Thromboembolism (pulmonary embolism, deep vein thrombosis)*.

Gastrointestinal Disorders: Common: Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence). Uncommon: Pancreatitis*.

Hepatobiliary Disorders: Common: Increased transaminases. Uncommon: Cholelithiasis. Rare: Hepatitis.

Skin and Subcutaneous Tissue Disorders: Uncommon: Cutaneous hypersensitivity (eg, rashes, pruritus, urticaria). Rare: Alopecia, photosensitivity reactions.

Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Muscle disorder (eg, myalgia, myositis, muscular spasms and weakness).

Reproductive System and Breast Disorders: Uncommon: Sexual dysfunction.

Investigations: Uncommon: Increased blood creatinine. Rare: Increased blood urea.

*In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving Fenbrat 300 versus patients receiving placebo (0.8% vs 0.5%; p=0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group vs 1.1% in the Fenbrat 300 group; p=0.022) and a statistically non-significant increase in deep vein thromboses [placebo: 1% (48/4900 patients) vs Fenbrat 300 1.4% (67/4895 patients); p=0.074].

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during post-marketing use of Fenbrat 300. A precise frequency cannot be estimated from the available data and is therefore classified as “not known”.

Respiratory, Thoracic and Mediastinal Disorders: Interstitial lung disease.

Musculoskeletal, Connective Tissue and Bone Disorders: Rhabdomyolysis.

What is the most important information I should know about Fenbrat 300?

  • Fenbrat 300 capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Fenbrat 300 capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose, change your dose, or stop taking Fenbrat 300 capsules without checking with your doctor.
  • Follow the diet, exercise, and weight loss program given to you by your health care provider.
  • Tell your doctor or dentist that you take Fenbrat 300 capsules before you receive any medical or dental care, emergency care, or surgery.
  • Muscle problems (myopathy) may occur with Fenbrat 300 capsules. The risk of muscle problems may be greater in elderly patients and in people who have kidney problems or low thyroid function. It may also be greater in those who take Fenbrat 300 capsules with certain other medicines (eg, colchicine; HMG-CoA reductase inhibitors [statins], such as simvastatin). Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort.
  • Lab tests, including liver function, kidney function, blood cholesterol, and complete blood cell counts, may be performed while you use Fenbrat 300 capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Fenbrat 300 capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Fenbrat 300 capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Fenbrat 300 capsules can cause harm to the fetus. If you become pregnant or plan to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fenbrat 300 capsules while you are pregnant. It is not known if Fenbrat 300 capsules is found in breast milk. Do not breast-feed while taking Fenbrat 300 capsules.

Fenbrat 300 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.
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Hypersensitivity to Fenbrat 300 or to any of the excipients of Fenbrat 300, Lipanthyl Supra 160 mg and Lipanthyl 67M.

Patients with hepatic insufficiency (including biliary cirrhosis, and unexplained persistent liver function abnormality) and renal insufficiency.

Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia, gallbladder disease and severe chronic kidney disease.

Fenbrat 300/Lipanthyl Supra 160 mg: It should not be taken by patients allergic to peanut or arachis oil or soya/soybean lecithin or related products due to the risk of hypersensitivity reactions.

Use in pregnancy: Fenbrat 300/Lipanthyl 67M: There are no adequate data from the use of Fenbrat 300 in pregnant woman. Animal studies have not demonstrated and teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity. The potential risk for humans is unknown. Therefore, film-coated tablet should only be used during pregnancy after a careful benefit/risk assessment.

Lipanthyl Supra 160 mg is contraindicated during pregnancy, in the absence of data. If unexpected pregnancy occurs while taking Fenbrat 300, treatment should be interrupted and consult a doctor.

Use in lactation: It is unknown whether Fenbrat 300 is excreted in human milk. A risk to the newborns/infants cannot be excluded. Lipanthyl Supra 160 mg is contraindicated during breastfeeding in the absence of data. Therefore, Fenbrat 300 should not be used during breastfeeding in nursing mother.

Use in children: Lipanthyl 67M: The safety and efficacy of Fenbrat 300 in children have not yet been established. Only limited pediatric data are available. Therefore, the use of Fenbrat 300 is not recommended in pediatric subjects <18 years.


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References

  1. DailyMed. "FENOFIBRATE: 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. DTP/NCI. "fenofibrate: 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).
  3. European Chemicals Agency - ECHA. "Fenofibrate: 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 Fenbrat 300 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 Fenbrat 300. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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