"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 Consumer (continued)
This medication may infrequently cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine.
This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.
Rarely, this medication has caused severe lowering of HDL ("good" cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments.
Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), unusual tiredness, chest pain, pain/redness/swelling of arms or legs.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Triglide (fenofibrate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking fenofibrate, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibric acid); or if you have any other allergies. This product may contain inactive ingredients (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis), alcohol use.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during pregnancy. Consult your doctor for more details.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Additional Triglide Information
Triglide - User Reviews
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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.
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