What are the possible side effects of Lipolex?
In rare cases, Lipolex can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking Lipolex 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 Lipolex: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking Lipolex and call your doctor at once if you have any of these other serious side effects:
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sharp stomach pain spreading to your back or shoulder blade;
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stomach pain just after eating a meal;
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nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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pain, swelling, warmth, or redness in one or both legs; or
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chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.
Less serious Lipolex side effects may include:
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headache, dizziness;
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back pain;
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joint pain, mild back pain;
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diarrhea, upset stomach; or
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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 Lipolex in details
Clinical Trials Experience
Because clinical studies 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.
Fenofibric acid is the active metabolite of Lipolex. Adverse events reported by 2% or more of patients treated with Lipolex and greater than placebo during double-blind, placebocontrolled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with Lipolex and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of Lipolex treatment in 1.6% of patients in double-blind trials.
Table 1: Adverse Events Reported by 2% or More of Patients Treated with Lipolex and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| BODY SYSTEM Adverse Event | Lipolex* (N = 439) | Placebo (N = 365) |
| BODY AS A WHOLE | ||
| Abdominal Pain | 4.6% | 4.4% |
| Back Pain | 3.4% | 2.5% |
| Headache | 3.2% | 2.7% |
| DIGESTIVE | ||
| Nausea | 2.3% | 1.9% |
| Constipation | 2.1% | 1.4% |
| INVESTIGATIONS | ||
| Abnormal Liver Tests | 7.5% | 1.4% |
| Increased AST | 3.4% | 0.5% |
| Increased ALT | 3.0% | 1.6% |
| Increased Creatine Phosphokinase | 3.0% | 1.4% |
| RESPIRATORY | ||
| Respiratory Disorder | 6.2% | 5.5% |
| Rhinitis | 2.3% | 1.1% |
| * Dosage equivalent to 135 mg Lipolex |
Clinical trials with Lipolex did not include a placebo-control arm. However, the adverse event profile of Lipolex was generally consistent with that of Lipolex. The following adverse events not listed above were reported in ≥ 3% of patients taking Lipolex alone:
Gastrointestinal Disorders: Diarrhea, dyspepsia
General Disorders and Administration Site Conditions: Pain
Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity
Nervous System Disorders: Dizzinesss
Postmarketing Experience
The following adverse events have been identified during postapproval use of Lipolex: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.
Because these events 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.
What is the most important information I should know about Lipolex?
- CIP - Lipolex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use CIP - Lipolex 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 CIP - Lipolex 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 CIP - Lipolex before you receive any medical or dental care, emergency care, or surgery.
- Muscle problems (myopathy) may occur with CIP - Lipolex. 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 CIP - Lipolex 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 CIP - Lipolex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use CIP - Lipolex with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
- CIP - Lipolex 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 CIP - Lipolex 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 CIP - Lipolex while you are pregnant. It is not known if CIP - Lipolex is found in breast milk. Do not breast-feed while taking CIP - Lipolex.
Lipolex contraindications
Hypersensitivity to Lipolex or to any of the excipients of Lipolex, 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.
Lipolex/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: Lipolex/Lipanthyl 67M: There are no adequate data from the use of Lipolex 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 Lipolex, treatment should be interrupted and consult a doctor.
Use in lactation: It is unknown whether Lipolex 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, Lipolex should not be used during breastfeeding in nursing mother.
Use in children: Lipanthyl 67M: The safety and efficacy of Lipolex in children have not yet been established. Only limited pediatric data are available. Therefore, the use of Lipolex is not recommended in pediatric subjects <18 years.
References
- 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).
- 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).
- 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 Lipolex 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 Lipolex. 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
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
