Stavudine Side Effects
Some side effects of stavudine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to stavudine: oral capsule, oral powder for reconstitution
Stop using stavudine and Get emergency medical help if you have any of these signs of an allergic reaction while taking stavudine: hives; difficulty 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;
feeling dizzy, light-headed, tired, or very weak;
stomach pain, nausea with vomiting; or
fast or uneven heart rate.
Stop using stavudine and call your doctor at once if you have a serious side effect such as:
signs of a new infection such as fever, chills, sore throat, flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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 (enlarged thyroid);
weakness, numbness, pain, or prickly feeling in your hands or feet;
problems with walking, breathing, speech, swallowing, or eye movement; or
severe lower back pain, loss of bladder or bowel control.
Less serious side effects of stavudine may include:
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. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to stavudine: oral capsule, oral capsule extended release, oral powder for reconstitution
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 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 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 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 side effects have included anemia, leukopenia, neutropenia, macrocytosis, and thrombocytopenia during postmarketing experience.
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 side effects have included rash (up to 40%) and pruritus.
Musculoskeletal side effects have included muscle weakness and decreased bone mineral density. Myalgia has been reported during postmarketing experience.
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 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 side effects have included at least one case of Fanconi syndrome.
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