Zerit Side Effects

Generic Name: stavudine

Please note - some side effects for Zerit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Zerit - for the Consumer

Zerit

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zerit:

Changes in body fat; diarrhea; headache; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; fever; muscle aches or weakness; numbness, tingling, or pain in the hands or feet; sore throat; stomach pain (with or without nausea or vomiting); stomach swelling; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); symptoms of lactic acidosis (eg, general body discomfort, cold feeling, dizziness, lightheadedness, fast or irregular heartbeat, rapid breathing, shortness of breath, unexplained weight loss); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, persistent nausea or vomiting); unusual bruising or bleeding; unusual tiredness or weakness; weakness in the arms or legs.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Zerit Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zerit Solution:

Changes in body fat; diarrhea; headache; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; fever; muscle aches or weakness; numbness, tingling, or pain in the hands or feet; sore throat; stomach pain (with or without nausea or vomiting); stomach swelling; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); symptoms of lactic acidosis (eg, general body discomfort, cold feeling, dizziness, lightheadedness, fast or irregular heartbeat, rapid breathing, shortness of breath, unexplained weight loss); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, persistent nausea or vomiting); unusual bruising or bleeding; unusual tiredness or weakness; weakness in the arms or legs.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (neuropathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy-generating capacity.

Nervous system

Nervous system side effects have included headache (up to 54%), peripheral neurologic symptoms/neuropathy (up to 52%), dizziness, abnormal dreams, somnolence, abnormal thinking, depression, and ototoxicity. Insomnia and severe motor weakness (usually with lactic acidosis) have been reported during postmarketing experience.

Peripheral neuropathy (PN) seen with the administration of stavudine is both dosage- and treatment duration-dependent. It is also more common in patients who are being treated with other neurotoxic drugs, who have previously experienced PN, or who have been diagnosed with AIDS at the time of starting treatment. PN is generally characterized by numbness, tingling, or pain in the feet or hands. Stavudine should be discontinued if peripheral neuropathy develops.

Hepatic

Hepatic side effects have included elevated bilirubin (all grades: up to 68%; greater than 2.6 times ULN: up to 16%), ALT (all grades: up to 50%; greater than 5 times ULN: up to 13%), AST (all grades: up to 53%; greater than 5 times ULN: up to 11%), and gamma glutamyltransferase (all grades: up to 28%; greater than 5 times ULN: up to 5%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination, including stavudine and other antiretroviral agents. Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis, hepatitis, and liver failure have been reported during postmarketing experience.

Caution should be exercised when administering stavudine to any patient with known risk factors for liver disease. However, cases of hepatic toxicity have also been reported in patients with no known risk factors. Treatment with stavudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis (fatigue, nausea, vomiting, abdominal pain, unexplained weight loss, tachypnea, dyspnea, motor weakness) or pronounced hepatotoxicity.

Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 53%), diarrhea (up to 50%), nausea and vomiting (39%), vomiting (up to 30%), pancreatitis, and dyspepsia. Anorexia and pancreatitis (including fatal cases) have been reported during postmarketing experience.

When stavudine is used in combination with other drugs that have pancreatic toxic effects (other nucleoside analogs or drugs to treat/prevent Pneumocystis pneumonia) the incidence of pancreatitis may increase.

Hematologic

Hematologic side effects have included anemia, leukopenia, neutropenia, macrocytosis, and thrombocytopenia during postmarketing experience.

Other

Other side effects have included edema. Abdominal pain, allergic reactions, and chills/fever have been reported during postmarketing experience.

Edema has been reported with use of stavudine although no causal relationship has been established.

Dermatologic

Dermatologic side effects have included rash (up to 40%) and pruritus.

Musculoskeletal

Musculoskeletal side effects have included muscle weakness and decreased bone mineral density. Myalgia has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included elevated amylase (all grades: up to 31%; greater than or equal to 1.4 times ULN: 14%; greater than 2 times ULN: up to 8%) and lipase (all grades: up to 27%; greater than 2 times ULN: up to 6%). Hyperlipidemia and progressive subcutaneous fat wasting have been reported. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral agents. Diabetes mellitus, hyperglycemia, lipoatrophy, lipodystrophy, and redistribution/accumulation of body fat have been reported during postmarketing experience.

Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. This syndrome has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Renal

Renal side effects have included at least one case of Fanconi syndrome.

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