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Retrovir

"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.

Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...

Retrovir

Retrovir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Retrovir (zidovudine) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Retrovir is not a cure for HIV or AIDS. It is an antiviral medication. This medication is available in generic form. Common side effects include headache, nausea, vomiting, trouble sleeping, or loss of appetite.

The recommended adult oral dose of Retrovir is 600 mg/day in divided doses in combination with other antiretroviral agents. The pediatric dose of Retrovir is based on the child's weight. Retrovir may interact with atovaquone, doxorubicin, fluconazole, ganciclovir, interferon-alfa, methadone, nelfinavir, phenytoin, probenecid, ribavirin, ritonavir, or stavudine. Tell your doctor all medications you use. During pregnancy, Retrovir should be used only when prescribed. However, HIV medicines are often given to pregnant women with HIV. Treatment decreases the risk of HIV transmission to the baby. This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Our Retrovir (zidovudine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Retrovir in Detail - Patient Information: 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.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: 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.

Stop taking zidovudine and call your doctor at once if you have any of these other serious side effects:

  • severe muscle pain;
  • signs of a new infection such as fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (goiter);
  • problems with walking, breathing, speech, swallowing, or eye movement;
  • weakness or prickly feeling in your fingers or toes;
  • severe lower back pain, loss of bladder or bowel control;
  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • sleep problems (insomnia);
  • mild nausea, constipation;
  • joint pain;
  • headache; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

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.

Read the entire detailed patient monograph for Retrovir (Zidovudine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Retrovir Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Headache, nausea, vomiting, trouble sleeping, or loss of appetite may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, anxiety, confusion), easy bruising/bleeding, skin/fingernail color changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures.

Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Retrovir (Zidovudine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Retrovir FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The frequency and severity of adverse reactions associated with the use of RETROVIR are greater in patients with more advanced infection at the time of initiation of therapy.

Table 3 summarizes events reported at a statistically significant greater incidence for patients receiving RETROVIR in a monotherapy study.

Table 3: Percentage (%) of Patients With Adverse Reactionsa in Asymptomatic HIV-1Infection (ACTG 019)

Adverse Reaction RETROVIR 500 mg/day
(n=453)
Placebo
(n = 428)
Body as a whole
  Asthenia 9%b 6%
  Headache 63% 53%
  Malaise 53% 45%
Gastrointestinal
  Anorexia 20% 11%
  Constipation  6%b 4%
  Nausea 51% 30%
  Vomiting 17% 10%
aReported in ≥5% of study population.
b 193 Not statistically significant versus placebo.

In addition to the adverse reactions listed in Table 3, adverse reactions observed at an incidence of ≥5% in any treatment arm in clinical studies (NUCA3001, NUCA3002, NUCB3001, and NUCB3002) were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, insomnia, musculoskeletal pain, myalgia, and neuropathy. Additionally, in these studies hyperbilirubinemia was reported at an incidence of ≤0.8%.

Selected laboratory abnormalities observed during a clinical study of monotherapy with RETROVIR are shown in Table 4.

Table 4: Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Patients With Asymptomatic HIV-1 Infection (ACTG 019)

Test (Abnormal Level) RETROVIR 500 mg/day
(n=453)
Placebo
(n = 428)
Anemia (Hgb < 8 g/dL) 1% < 1%
Granulocytopenia ( < 750 cells/mm³) 2% 2%
Thrombocytopenia (platelets < 50,000/mm³) 0% < 1%
ALT (>5 x ULN) 3% 3%
AST (>5 x ULN) 1% 2%
ULN = Upper limit of normal.

Pediatrics

The clinical adverse reactions reported among adult recipients of RETROVIR may also occur in pediatric patients.

Study ACTG 300: Selected clinical adverse reactions and physical findings with a ≥5% frequency during therapy with EPIVIR® (lamivudine) Oral Suspension 4 mg/kg twice daily plus RETROVIR 160 mg/m² 3 times daily compared with didanosine in therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 5.

Table 5: Selected Clinical Adverse Reactions and Physical Findings (≥5% Frequency) in Pediatric Patients in Study ACTG 300

Adverse Reaction EPIVIR plus RETROVIR
(n = 236)
Didanosine
(n = 235)
Body as a whole
  Fever 25% 32%
Digestive
  Hepatomegaly 11% 11%
  Nausea & vomiting 8% 7%
  Diarrhea 8% 6%
  Stomatitis 6% 12%
  Splenomegaly 5% 8%
Respiratory
  Cough 15% 18%
  Abnormal breath sounds/wheezing 7% 9%
Ear, Nose, and Throat
  Signs or symptoms of ears 7% 6%
  Nasal discharge or congestion 8% 11%
Other
  Skin rashes 12% 14%
  Lymphadenopathy 9% 11%
a Includes pain, discharge, erythema, or swelling of an ear.

Selected laboratory abnormalities experienced by therapy-naive ( < 56 days of antiretroviral therapy) pediatric patients are listed in Table 6.

Table 6: Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Pediatric Patients in Study ACTG 300

(Abnormal Level) RETROVIR Didanosine
Neutropenia (ANC < 400 cells/mm³) 8% 3%
Anemia (Hgb < 7.0 g/dL) 4% 2%
Thrombocytopenia (platelets < 50,000/mm³) 1% 3%
ALT (>10 x ULN) 1% 3%
AST (>10 x ULN) 2% 4%
Lipase (>2.5 x ULN) 3% 3%
Total amylase (>2.5 x ULN) 3% 3%
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.

Macrocytosis was reported in the majority of pediatric patients receiving RETROVIR 180 mg/m every 6 hours in open-label studies. Additionally, adverse reactions reported at an incidence of < 6% in these studies were congestive heart failure, decreased reflexes, ECG abnormality, edema, hematuria, left ventricular dilation, nervousness/irritability, and weight loss.

Use for the Prevention of Maternal-Fetal Transmission of HIV-1

In a randomized, double-blind, placebo-controlled trial in HIV-1-infected women and their neonates conducted to determine the utility of RETROVIR for the prevention of maternal-fetal HIV-1 transmission, RETROVIR Syrup at 2 mg/kg was administered every 6 hours for 6 weeks to neonates beginning within 12 hours following birth. The most commonly reported adverse reactions were anemia (hemoglobin < 9.0 g/dL) and neutropenia ( < 1,000 cells/mm3). Anemia occurred in 22% of the neonates who received RETROVIR and in 12% of the neonates who received placebo.The mean difference in hemoglobin values was less than 1.0 g/dL for neonates receiving RETROVIR compared with neonates receiving placebo. No neonates with anemia required transfusion and all hemoglobin values spontaneously returned to normal within 6 weeks after completion of therapy with RETROVIR. Neutropenia in neonates was reported with similar frequency in the group that received RETROVIR (21%) and in the group that received placebo (27%). The long-term consequences of in utero and infant exposure to RETROVIR are unknown.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of RETROVIR. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to RETROVIR.

Body as a Whole: Back pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Cardiovascular: Cardiomyopathy, syncope.

Endocrine: Gynecomastia.

Eye: Macular edema.

Gastrointestinal: Dysphagia, flatulence, oral mucosa pigmentation, mouth ulcer.

General: Sensitization reactions including anaphylaxis and angioedema, vasculitis.

Hemic and Lymphatic: Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.

Hepatobiliary Tract and Pancreas: Hepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis.

Musculoskeletal: Increased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV-1 disease), rhabdomyolysis, tremor.

Nervous: Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.

Respiratory: Dyspnea, rhinitis, sinusitis.

Skin: Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria. Special Senses: Amblyopia, hearing loss, photophobia, taste perversion. Urogenital: Urinary frequency, urinary hesitancy.

Read the entire FDA prescribing information for Retrovir (Zidovudine) »

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Retrovir - User Reviews

Retrovir User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Retrovir sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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