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Zerit

"The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or f"...

Zerit

Zerit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zerit (stavudine) is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is an antiviral medication that prevents human immunodeficiency virus (HIV) from multiplying in the body. This medication is available in generic form. Common side effects include headache or diarrhea.

The recommended adult dosage of Zerit is based on body weight as follows: For patients weighing less than 60 kg: 30 mg every 12 hours; for patients weighing at least 60 kg: 40 mg every 12 hours. Consult your doctor for pediatric dosing. Zerit may interact with didanosine, doxorubicin, hydroxyurea, interferon-alfa, ribavirin, or zidovudine. Tell your doctor all medications and supplements you use. During pregnancy, Zerit should be used only when prescribed. It is normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Zerit (stavudine) 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.

Zerit in Detail - Patient Information: Side Effects

Stop using stavudine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • high blood sugar - increased thirst, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting; or
  • any signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, or unusual weakness.

Less serious side effects may include:

  • diarrhea;
  • muscle pain;
  • headache;
  • mild skin rash; 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zerit (Stavudine) »

What is Patient Information Overview?

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

Zerit Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Headache or diarrhea 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).

This medication can cause severe nerve problems in the hands/feet/legs (peripheral neuropathy). Symptoms may include numbness/tingling/pain, muscle weakness, or decreased muscle control. If you experience any of these symptoms, contact your doctor immediately so that you can be monitored closely. Your doctor may decide to reduce or stop your dose of stavudine.

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 Zerit (Stavudine)»

What is Prescribing information?

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

Zerit FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

When ZERIT is used in combination with other agents with similar toxicities, the incidence of adverse reactions may be higher than when stavudine is used alone.

Clinical Trial Experience in Adults

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 clinical practice.

Selected adverse reactions that occurred in adult patients receiving ZERIT in a controlled monotherapy study (Study AI455-019) are provided in Table 2.

Table 2: Selected Adverse Reactions in Study AI455-019a (Monotherapy)

Adverse Reaction Percent (%)
ZERITb (40 mg twice daily)
(n=412)
zidovudine (200 mg 3 times daily)
(n=402)
Headache 54 49
Diarrhea 50 44
Peripheral Neurologic Symptoms/Neuropathy 52 39
Rash 40 35
Nausea and Vomiting 39 44
a The incidences reported included all severity grades and all reactions regardless of causality.
b Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks.

Pancreatitis was observed in 3 of the 412 adult patients who received ZERIT in study AI455-019.

Selected adverse reactions that occurred in antiretroviral-naive adult patients receiving ZERIT from two controlled combination studies are provided in Table 3.

Table 3: Selected Adverse Reactionsa in START 1 and START 2b Studies (Combination Therapy)

Adverse Reaction Percent (%)
START 1 START2b
ZERIT + lamivudine + indinavir
(n=100c)
zidovudine+ lamivudine+ indinavir
(n=102)
ZERIT+ didanosine+ indinavir
(n=102c)
zidovudine + lamivudine + indinavir
(n=103)
Nausea 43 63 53 67
Diarrhea 34 16 45 39
Headache 25 26 46 37
Rash 18 13 30 18
Vomiting 18 33 30 35
Peripheral Neurologic Symptoms/ Neuropathy 8 7 21 10
a The incidences reported included all severity grades and all reactions regardless of causality.
b START 2 compared two triple-combination regimens in 205 treatment-naive patients. Patients received either ZERIT (40 mg twice daily) plus didanosine plus indinavir or zidovudine plus lamivudine plus indinavir.
c Duration of stavudine therapy = 48 weeks.

Selected laboratory abnormalities reported in a controlled monotherapy study (Study AI455-019) are provided in Table 4.

Table 4: Selected Laboratory Abnormalities in Study AI455-019a,b

Parameter Percent (%)
ZERIT (40 mg twice daily)
(n=412)
zidovudine (200 mg 3 times daily)
(n=402)
AST (SGOT) ( > 5.0 x ULN) 11 10
ALT (SGPT) ( > 5.0 x ULN) 13 11
Amylase ( ≥ 1.4 x ULN) 14 13
a Data presented for patients for whom laboratory evaluations were performed.
b Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks.
ULN = upper limit of normal.

Selected laboratory abnormalities reported in two controlled combination studies are provided in Tables 5 and 6.

Table 5: Selected Laboratory Abnormalities in START 1 and START 2 Studies (Grades 3-4)

Parameter Percent(%)
START 1 START 2
ZERIT + lamivudine + indinavir
(n=100)
zidovudine + lamivudine + indinavir
(n=102)
ZERIT + didanosine + indinavir
(n=102)
zidovudine + lamivudine + indinavir
(n=103)
Bilirubin ( > 2.6 x ULN) 7 6 16 8
AST (SGOT) ( > 5 x ULN) 5 2 7 7
ALT (SGPT) ( > 5 x ULN) 6 2 8 5
GGT ( > 5 x ULN) 2 2 5 2
Lipase ( > 2 x ULN) 6 3 5 5
Amylase ( > 2 x ULN) 4 < 1 8 2
ULN = upper limit of normal.

Table 6: Selected Laboratory Abnormalities in START 1 and START 2 Studies (All Grades)

Parameter Percent (%)
START1 START2
ZERIT + lamivudine +indinavir
(n=100)
zidovudine + lamivudine + indinavir
(n=102)
ZERIT + didanosine + indinavir
(n=102)
zidovudine + lamivudine + indinavir
(n=103)
Total Bilirubin 65 60 68 55
AST (SGOT) 42 20 53 20
ALT (SGPT) 40 20 50 18
GGT 15 8 28 12
Lipase 27 12 26 19
Amylase 21 19 31 17

Clinical Trial Experience in Pediatric Patients

Adverse reactions and serious laboratory abnormalities reported in pediatric patients from birth through adolescence during clinical trials were similar in type and frequency to those seen in adult patients. [See Use in Specific Populations.]

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of ZERIT. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to ZERIT, or a combination of these factors.

Body as a Whole: abdominal pain, allergic reaction, chills/fever, and redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Digestive Disorders: anorexia.

Exocrine Gland Disorders: pancreatitis, including fatal cases [see WARNINGS AND PRECAUTIONS].

Hematologic Disorders: anemia, leukopenia, thrombocytopenia, neutropenia, and macrocytosis.

Liver: symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS], hepatitis and liver failure.

Metabolic Disorders: lipoatrophy, lipodystrophy [see WARNINGS AND PRECAUTIONS], diabetes mellitus and hyperglycemia.

Musculoskeletal: myalgia.

Nervous System: insomnia, severe motor weakness (most often reported in the setting of lactic acidosis) [see WARNINGS AND PRECAUTIONS].

Use with Didanosine- and Hydroxyurea-Based Regimens

When stavudine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when stavudine is used alone. Thus, patients treated with ZERIT in combination with didanosine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see WARNINGS AND PRECAUTIONS]. The combination of ZERIT and hydroxyurea, with or without didanosine, should be avoided.

Read the entire FDA prescribing information for Zerit (Stavudine) »

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Zerit - User Reviews

Zerit 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 Zerit 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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