Important Safety Information
What is the most important information I should know about TRUVADA?
TRUVADA can cause serious side effects:
- Too much lactic acid in your blood (lactic acidosis), which
is a serious medical emergency. Symptoms of lactic acidosis include weakness or
being more tired than usual, unusual muscle pain, being short of breath or fast
breathing, nausea, vomiting, stomach-area pain, cold or blue hands and feet, feeling
dizzy or lightheaded, and/or fast or abnormal heartbeats.
- Serious liver problems. Your liver may become
large and tender, and you may develop fat in your liver. Symptoms of liver problems
include your skin or the white part of your eyes turns yellow, dark “tea-colored”
urine, light-colored stools, loss of appetite for several days or longer, nausea,
and/or stomach-area pain.
- You may be more likely to get lactic acidosis or serious
liver problems if you are female, very overweight (obese), or have been
taking TRUVADA for a long time. In some cases, these serious conditions have led
to death. Call your healthcare provider right away if you have any symptoms of these
- Worsening of hepatitis B (HBV) infection. If you
also have HBV and take TRUVADA, your hepatitis may become worse if you stop taking
TRUVADA. Do not stop taking TRUVADA without first talking to your healthcare provider.
If your healthcare provider tells you to stop taking TRUVADA, they will need to
watch you closely for several months to monitor your health. TRUVADA is not approved
for the treatment of HBV.
If your healthcare provider has prescribed TRUVADA to help reduce the risk of
getting HIV-1 infection, you should also know:
- You must be HIV-negative before you start taking TRUVADA to reduce the risk of getting HIV-1. You must get tested to make sure that you do not already have HIV-1 infection. Do not take TRUVADA to reduce the risk of getting HIV-1 unless you are confirmed to be HIV-negative.
- Many HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting TRUVADA or at any time while taking TRUVADA. Symptoms of new HIV-1 infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting, diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.
- Just taking TRUVADA may not keep you from getting HIV-1. You must continue using safer sex practices while you are taking TRUVADA to reduce your risk of getting HIV-1. To further reduce your risk of getting HIV-1:
- Get tested for other sexually transmitted infections. Other infections make it easier for HIV-1 to infect you.
- Get information and support to help reduce risky sexual behavior.
- Have fewer sex partners.
- Do not miss any doses of TRUVADA. Missing doses may increase your risk of getting HIV-1 infection.
- You must stay HIV-negative to keep taking TRUVADA to reduce your risk of getting HIV-1:
- Know your HIV-1 status and the HIV-1 status of your partners.
- Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you.
- If you think you were exposed to HIV-1, tell your healthcare provider right away.
- If you do become HIV-1 positive, you need more medicine than TRUVADA alone to treat HIV-1. TRUVADA itself is not a complete treatment for HIV-1.
- If you have HIV-1 and take only TRUVADA, your HIV-1 may become harder to treat.