Stavudine Side Effects

It is possible that some side effects of stavudine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to stavudine: oral capsule, oral powder for solution, oral powder for suspension

As well as its needed effects, stavudine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking stavudine, check with your doctor immediately:

More common
  • Burning, numbness, tingling, or painful sensations
  • chills with fever
  • tingling, burning, numbness, or pain in the hands or feet
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Less common
  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • joint pain
  • muscle pain
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
Rare
  • Nausea and vomiting
  • stomach pain (severe)
Incidence not known
  • Abdominal or stomach discomfort or pain
  • black, tarry stools
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blurred vision
  • chest pain
  • constipation
  • darkened urine
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • dry mouth
  • fast, shallow breathing
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort
  • general tiredness and weakness
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • muscle cramping, pains, or stiffness
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination
  • sleepiness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • swollen glands
  • swollen joints
  • troubled breathing
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • yellow eyes or skin

Some stavudine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Headache
  • loss of appetite
  • weight loss
Less common
  • Difficulty with sleeping
  • lack of strength or energy
  • stomach pain (mild)
Incidence not known
  • Gaining weight around your neck, upper back, breast, face, or waist
  • sleeplessness
  • unable to sleep

For Healthcare Professionals

Applies to stavudine: oral capsule, oral capsule extended release, oral powder for reconstitution

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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

Other

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

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

Dermatologic

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

Musculoskeletal

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

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.[Ref]

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.[Ref]

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.[Ref]

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