Recommended Topic Related To:

Triglide

"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...

Triglide

Triglide

SIDE EFFECTS

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 rates observed in clinical practice.

Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

BODY SYSTEM Adverse Reaction Fenofibrate* (N=439) Placebo (N=365)
BODY AS A WHOLE
  Abdominal Pain 4.60% 4.40%
  Back Pain 3.40% 2.50%
  Headache 3.20% 2.70%
DIGESTIVE
  Nausea 2.30% 1.90%
  Constipation 2.10% 1.40%
METABOLIC AND NUTRITIONAL DISORDERS
  Abnormal Liver Tests 7.5%** 1.40%
  Increased AST 3.4%** 0.50%
  Increased ALT 3.00% 1.60%
  Increased Creatine Phosphokinase 3.00% 1.40%
RESPIRATORY
  Respiratory Disorder 6.20% 5.50%
  Rhinitis 2.30% 1.10%
* Dosage equivalent to 200 mg fenofibrate capsules, micronized. Dosage comparable to 160 mg Triglide.
** Significantly different from placebo.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, asthenia, and severely depressed HDL-cholesterol levels. Because these reactions 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.

Read the Triglide (fenofibrate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Coumarin Anticoagulants

Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR.

Caution should be exercised when coumarin anticoagulants are given in conjunction with Triglide. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized [see WARNINGS AND PRECAUTIONS].

Immunosuppressants

Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including Triglide, there is a risk that an interaction will lead to deterioration of renal function. The benefits and risks of using Triglide with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed and renal function monitored.

Bile-Acid Binding Resins

Since bile acid binding resins may bind other drugs given concurrently, patients should take Triglide at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption.

Colchicine

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Read the Triglide Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 2/15/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Triglide - User Reviews

Triglide User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Triglide sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations