Important Risk Information

The most serious side effects of VIREAD

VIREAD can cause serious side effects, including:

1. Build-up of acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take VIREAD or similar (nucleoside analog) medicines. Lactic acidosis is a serious medical emergency that can lead to death.

Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get the following symptoms, which could be signs of lactic acidosis:

  • Feeling very weak or tired
  • Have unusual (not normal) muscle pain
  • Have trouble breathing
  • Have stomach pain with:
    • Nausea (feel sick to your stomach)
    • Vomiting
  • Feeling cold, especially in your arms and legs
  • Feeling dizzy or lightheaded
  • Have a fast or irregular heartbeat

2. Severe liver problems. Severe liver problems can happen in people who take VIREAD or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take VIREAD.

Call your healthcare provider right away if you have any of the following symptoms of liver problems:

  • Your skin or the white part of your eyes turns yellow (jaundice)
  • Dark “tea-colored” urine
  • Light-colored bowel movements (stools)
  • Loss of appetite for several days or longer
  • Nausea
  • Stomach pain

You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking VIREAD or a similar medicine for a long time.

3. Worsening of your Hepatitis B infection. Your hepatitis B virus (HBV) infection may become worse (flare-up) if you take VIREAD and then stop it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

  • Do not let your VIREAD run out. Refill your prescription or talk to your healthcare provider before your VIREAD is all gone
  • Do not stop taking VIREAD without first talking to your healthcare provider
  • If you stop taking VIREAD, your healthcare provider will need to check your health often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VIREAD

4. Talk to your doctor about taking an HIV test before starting treatment with VIREAD for chronic hepatitis B because in case you have HIV and chronic hepatitis B you will need to take additional medicines for your HIV.

VIREAD may cause other serious side effects:

  • New or worse kidney problems can happen in some people who take VIREAD. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with VIREAD
  • Bone problems can happen in some people who take VIREAD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones

Tell your healthcare provider about all the medicines you take:

Do not take VIREAD if:

  • You are already taking TRUVADA®, or ATRIPLA® because VIREAD is one of the active ingredients in TRUVADA and ATRIPLA
  • You are currently taking HEPSERA®

Especially tell your healthcare provider if you take the following medications, as the dose of these other medications may need to be changed:

  • Didanosine (VIDEX®, VIDEX® EC)
  • Atazanavir (REYATAZ®)
  • Lopinavir with ritonavir (KALETRA®)

Keep a list of all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements to show your healthcare provider or pharmacist when you get a new medicine.

The most common side effects of VIREAD in patients with compensated liver disease:

  • Nausea
  • Stomach pain
  • Diarrhea
  • Headache
  • Dizziness
  • Fatigue
  • Common cold symptoms such as sore throat and runny nose
  • Back pain
  • Skin rash

The most common side effects of VIREAD in patients with decompensated liver disease:

  • Stomach pain
  • Nausea
  • Sleeplessness
  • Itching
  • Vomiting
  • Dizziness
  • Fever

These are not all the possible side effects of VIREAD. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about the side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.