Cardiovascular Risks
Treximet may increase the risk of serious cardiovascular events, including heart attack, stroke, and blood clots.
This risk may be higher in people who already have cardiovascular disease or who have risk factors such as high blood pressure, high cholesterol, diabetes, smoking, or a family history of heart disease.
Before taking Treximet, tell your healthcare provider about any heart or circulation problems you have.
Gastrointestinal Risks
Treximet contains naproxen, a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of serious stomach and intestinal problems.
These may include ulcers, gastrointestinal bleeding, and perforation of the stomach or intestines.
The risk may be higher in people with a history of ulcers or gastrointestinal bleeding, older adults, and those taking other medications that can increase bleeding risk.
Seek medical attention if you develop severe stomach pain, black or bloody stools, or vomiting that contains blood or looks like coffee grounds.
Kidney Problems
Treximet may cause or worsen kidney problems.
Use extra caution if you have a history of kidney disease, dehydration, heart failure, or if you take medications that can affect kidney function.
Your healthcare provider may monitor your kidney function, especially if you use Treximet frequently or have existing kidney problems.
Pregnancy and Breastfeeding
Tell your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before taking Treximet.
Because Treximet contains naproxen, it may cause harm during pregnancy, particularly later in pregnancy. Your doctor will determine whether the potential benefits outweigh the possible risks.
If you are breastfeeding, discuss the use of Treximet with your healthcare provider before taking it.
Allergic Reactions
Treximet may cause serious allergic reactions in some people.
Symptoms may include hives, rash, swelling of the face, lips, tongue, or throat, difficulty breathing, or severe dizziness.
People who have had allergic reactions to aspirin, naproxen, or other NSAIDs may be at greater risk.
Seek emergency medical attention if you develop symptoms of a serious allergic reaction.
Liver Problems
Treximet may rarely cause liver problems, including serious liver injury.
Tell your healthcare provider if you have liver disease or take other medications that can affect the liver.
Contact your doctor if you develop symptoms such as yellowing of the skin or eyes, dark urine, persistent nausea, unusual tiredness, or pain in the upper right side of the abdomen.
Dizziness and Drowsiness
Treximet may cause dizziness, drowsiness, or other effects that can reduce alertness.
Avoid driving, operating machinery, or performing activities that require full concentration until you know how the medication affects you.
Alcohol or other medications that cause drowsiness may increase these effects.
Use in Pediatric Patients
Treximet is approved for the acute treatment of migraine in pediatric patients 12 years of age and older.
Its safety and effectiveness have not been established for children younger than 12 years.
Children and adolescents should only use Treximet under the direction of a healthcare provider.
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