Adefovir

Name: Adefovir

Adefovir Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

  • little or no urinating;
  • swelling, rapid weight gain;
  • confusion, loss of appetite, vomiting, pain in your side or lower back; or
  • severe stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • mild stomach pain, diarrhea, gas, indigestion;
  • weakness; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What do I need to tell my doctor BEFORE I take Adefovir?

  • If you have an allergy to adefovir or any other part of adefovir.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking a drug that has tenofovir in it.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take adefovir with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Adefovir?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine is not a cure for hepatitis infection. Stay under the care of your doctor.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • This medicine is not approved for use in children younger than 12 years old. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using adefovir while you are pregnant.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Muscle pain or weakness.
  • Bone pain.

Contraindications

Hypersensitivity to adefovir or any component of the formulation

Dosing Hepatic Impairment

No adjustment required.

Storage

Store controlled room temperature of 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, diarrhea, flatulence, abdominal pain, nausea, vomiting, or loss of strength and energy. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), muscle pain, muscle weakness, or bone pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

For the Consumer

Applies to adefovir: oral tablet

Along with its needed effects, adefovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking adefovir:

More common
  • Dark urine
  • general tiredness and weakness
  • light-colored stools
  • nausea and vomiting
  • upper right abdomen or stomach pain
  • yellow eyes and skin
Less common
  • Blood in the urine
  • change in frequency of urination or amount of urine
  • difficult breathing
  • drowsiness
  • increased thirst
  • loss of appetite
  • swelling of the feet or lower legs
  • weakness
Rare
  • Fast, shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • shortness of breath
  • sleepiness
  • unusual tiredness or weakness
Incidence not known
  • Bloating
  • bone fractures, especially of the thigh bone
  • bone pain
  • chills
  • cloudy urine
  • constipation
  • convulsions
  • darkened urine
  • decreased frequency or amount of urine
  • fast heartbeat
  • fever
  • increase in the amount of urine
  • increased blood pressure
  • indigestion
  • lower back or side pain
  • muscular pain, tenderness, wasting, or weakness
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • swelling of the face, fingers, or lower legs
  • weight gain

Some side effects of adefovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • headache
  • lack or loss of strength
Less common
  • Acid or sour stomach
  • belching
  • bloated or full feeling
  • diarrhea
  • excess air or gas in the stomach or intestines
  • heartburn
  • passing gas
  • stomach discomfort, upset, or pain

Usual Adult Dose for Chronic Hepatitis B

10 mg orally once a day, without regard to food

Usual Pediatric Dose for Chronic Hepatitis B

Less than 12 years: Not recommended.
12 years or older: 10 mg orally once a day, without regard to food

(web3)