SYMTUZA® can cause serious side effects including:
Worsening of hepatitis B virus infection. Your
healthcare provider will test you for hepatitis B virus (HBV) before starting treatment
with SYMTUZA®. If you have HBV infection and take SYMTUZA®, your
HBV may get worse (flare-up) if you stop taking SYMTUZA®.
Do not stop taking SYMTUZA® without first talking to your
Do not run out of SYMTUZA®. Refill your prescription or talk to
your healthcare provider before your SYMTUZA® is all gone.
If you stop taking SYMTUZA®, your healthcare provider will need to
check your health often and do blood tests regularly for several months to check
your HBV infection or give you a medicine to treat your HBV infection. Tell your
healthcare provider about any new or unusual symptoms you may have after you
stop taking SYMTUZA®.
Change in liver enzymes. People with a history of hepatitis B or C
virus infection or who have certain liver enzyme changes may have an increased risk of
developing new or worsening liver problems during treatment with SYMTUZA®.
Liver problems can also happen during treatment with SYMTUZA® in people
without a history of liver disease. Your healthcare provider may need to do tests to
check your liver enzymes before and during treatment with SYMTUZA®.
Severe liver problems. In rare cases, severe liver problems can
happen that can lead to death. Tell your healthcare provider right away if you
get these symptoms:
Skin or the white part of your eyes turn yellow
Dark "tea-colored" urine
Loss of appetite for several days or longer
Stomach area pain
SYMTUZA® may cause severe or life-threatening skin reactions or
rashes which may sometimes require treatment in a hospital. Call your healthcare
provider right away if you develop a rash. Stop taking SYMTUZA® and
call your healthcare provider right away if you develop any skin changes with symptoms below:
Muscle or joint pain
Blisters or skin lesions
Mouth sores or ulcers
Red or inflamed eyes, like "pink eye" (conjunctivitis)
Do not take SYMTUZA® with any of the following medicines: alfuzosin,
carbamazepine, cisapride, colchicine (if you have liver or kidney problems),
dronedarone, elbasvir and grazoprevir, ergot-containing medicines (such as:
dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide,
lovastatin or a product that contains lovastatin, lurasidone, midazolam (when taken by
mouth), naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's
wort (Hypericum perforatum) or a product that contains St. John's wort,
sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin or a product
that contains simvastatin, or triazolam.
Serious problems can happen if you take any of these medicines with
have liver problems (including hepatitis B or hepatitis C), have kidney problems, are
allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other
are pregnant (if you become pregnant while taking SYMTUZA®), or plan to
become pregnant. It is unknown if SYMTUZA® will harm your unborn baby.
SYMTUZA® should not be used during pregnancy.
are breastfeeding or plan to breastfeed. Do not breastfeed if you take
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines
interact with SYMTUZA®. Keep a list of your medicines to show your healthcare
provider and pharmacist. Do not start taking a new medicine without telling your
Take SYMTUZA® 1 time a day with food.
SYMTUZA® may cause serious side effects including:
See "What is the most important information I should know about
Immune system changes can happen in people who start HIV
New or worse kidney problems, including kidney failure.
Your healthcare provider should do blood and urine tests to check your kidneys
before you start and while you are taking SYMTUZA®.
Too much lactic acid in your blood (lactic acidosis).
Too much lactic acid is a serious but rare medical emergency that can lead to
death. Tell your healthcare provider right away if you get these
symptoms: weakness or being more tired than usual, unusual muscle
pain, being short of breath or fast breathing, stomach pain with nausea and
vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or
Diabetes and high blood sugar (hyperglycemia). Some people who take
protease inhibitors including SYMTUZA® can get high blood sugar, develop
diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an
increase in thirst or if you start urinating more often while taking
Changes in body fat can happen in people taking HIV-1
Increased bleeding can occur in people with hemophilia who are
The most common side effects of SYMTUZA® are: Diarrhea, rash,
nausea, fatigue, headache, stomach problems, and gas.
These are not all of the possible side effects of SYMTUZA®.
Call your doctor for medical advice about side effects. You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088. You may also report side effects to Janssen Products, LP at
Please see full Product Information, including Boxed Warning