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Stavudine Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 29, 2025.

Applies to stavudine: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule; powder for solution)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported.

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

Coadministration of stavudine and didanosine is contraindicated because of increased risk of serious and/or life-threatening events.

Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine.

Serious side effects of stavudine

Along with its needed effects, stavudine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking stavudine:

More common side effects

  • burning, numbness, tingling, or painful sensations
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

Incidence not known

  • black, tarry stools
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blurred vision
  • chest pain
  • chills
  • constipation
  • cough
  • darkened urine
  • decreased appetite
  • depression or indentation of the skin
  • diarrhea
  • difficulty in moving
  • difficulty swallowing
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort
  • general tiredness and weakness
  • hives, itching, skin rash
  • indigestion
  • joint pain or swelling
  • light-colored stools
  • loss of appetite
  • muscle cramping, pains, or stiffness
  • nausea
  • 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 (severe)
  • sleepiness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain or discomfort
  • swollen glands
  • tightness in the chest
  • trembling or other problems with muscle control or coordination
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting
  • yellow eyes or skin

Other side effects of stavudine

Some side effects of stavudine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • headache

Incidence not known

  • trouble sleeping

Managing side effects (general information)

For healthcare professionals

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

General adverse events

This drug was associated with many side effects (e.g., polyneuropathy, lactic acidosis, lipoatrophy) for which mitochondrial toxicity was a potential underlying mechanism.[Ref]

Hepatic

In a monotherapy trial, elevated ALT (greater than 5 times the upper limit of normal [5 x ULN]), AST (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) were reported in 13%, 11%, and 2% of patients, respectively. Elevated ALT (up to 5 x ULN) and AST (up to 5 x ULN) were reported in 65% and 63% of patients, respectively.

In combination therapy trials, elevated AST (grades 3 to 4: up to 7%; all grades: up to 53%), ALT (grades 3 to 4: up to 8%; all grades: up to 50%), bilirubin (grades 3 to 4: up to 16%; all grades: up to 68%), and GGT (grades 3 to 4: up to 5%; all grades: up to 28%) were reported; grades 3 to 4 AST, ALT, and GGT elevations were greater than 5 x ULN and grades 3 to 4 bilirubin elevations were greater than 2.6 x ULN.

In clinical trials, modest elevations of hepatic transaminases not requiring dose adjustment were reported in up to 13% of patients.

Hepatosplenomegaly (up to 72%) was reported in children; this side effect was not listed for adults.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs alone or in combination, including this drug and other antiretroviral agents.

Fatal hepatic events were reported most often in patients treated with this drug in combination with hydroxyurea and didanosine.[Ref]

Nervous system

In clinical trials, peripheral neuropathy requiring or leading to dose adjustment (regardless of severity) was reported in up to 24% of patients. Other peripheral neurological symptoms not requiring dose changes were reported in up to 39% of patients. Neuropathy requiring dose adjustment was reported in up to 14% of patients.

Peripheral sensory neuropathy (generally characterized by numbness, tingling, or pain in the feet or hands) has been reported. Peripheral neuropathy (some cases severe) was dose-related and occurred more often in patients with advanced HIV disease, with history of peripheral neuropathy, or using other drugs associated with neuropathy. Symptoms generally resolved after dose reduction or interruption of this drug.

Syncope (up to 15%), encephalopathy (up to 17%), abnormal gait (up to 11%), tremor (up to 11%), hyperkinesia (up to 10%), ear disorder (up to 39%), ear pain (up to 45%), otitis media (up to 15%), and speech disorder (up to 10%) were reported in children; these side effects were not listed for adults.

Most cases of motor weakness occurred in the setting of symptomatic hyperlactatemia or lactic acidosis syndrome. Symptoms have continued or worsened after therapy was stopped.[Ref]

Gastrointestinal

In a monotherapy trial, elevated amylase (at least 1.4 x ULN) was reported in 14% of patients.

In combination therapy trials, elevated amylase (grades 3 to 4: up to 8%; all grades: up to 31%) and lipase (grades 3 to 4: up to 6%; all grades: up to 26%) were reported; grades 3 to 4 amylase and lipase elevations were greater than 2 x ULN.

Ulcerative stomatitis (up to 45%), melena (up to 11%), tooth caries (up to 11%), dysphagia (up to 15%), aphthous stomatitis (up to 10%), cheilitis (up to 10%), gastrointestinal disorder (up to 15%), and glossitis (up to 10%) were reported in children; these side effects were not listed for adults.

Abdominal pain, elevated lipase, and pancreatitis (including fatal cases) have also been reported during postmarketing experience.[Ref]

Other

Antiretroviral therapy:

Infection (up to 95%), accidental injury (up to 80%), AIDS (up to 22%), death (up to 17%), face edema (up to 25%), mucous membrane disorder (up to 11%), peripheral edema (up to 10%), and enlarged abdomen (up to 10%) were reported in children; these side effects were not listed for adults.

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

Chills/fever have also been reported during postmarketing experience.[Ref]

Dermatologic

Subcutaneous fat loss was most apparent in the face, limbs, and buttocks. The incidence and severity of lipoatrophy have been linked to cumulative exposure. Often, lipoatrophy was not reversible when this drug was discontinued.

Ecchymosis (up to 30%), lesions (up to 55%), vesiculobullous rash (up to 25%), dry skin (up to 35%), skin discoloration (up to 20%), seborrhea (up to 11%), skin disorder (up to 15%), fungal dermatitis (up to 15%), nail disorder (up to 15%), petechial rash (up to 15%), skin ulcer (up to 10%), and herpes zoster (up to 15%) were reported in children; these side effects were not listed for adults.

Lipoatrophy has also been reported during postmarketing experience.[Ref]

Musculoskeletal

Arthrosis (up to 11%) was reported in children; this side effect was not listed for adults.

Myalgia has also been reported during postmarketing experience.[Ref]

Psychiatric

Personality disorder (up to 11%) was reported in children; this side effect was not listed for adults.

Insomnia has also been reported during postmarketing experience.[Ref]

Hematologic

In a monotherapy trial, decreased neutrophils (less than 750/mm3) and platelets (less than 50,000/mm3) were reported in 5% and 3% of patients, respectively.

Low hemoglobin (less than 8 g/dL) was reported in less than 1% of patients[Ref]

Metabolic

Antiretroviral therapy:

Cachexia (up to 15%) and dehydration (up to 10%) were reported in children; these side effects were not listed for adults.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received this drug plus didanosine with other antiretroviral agents.

Anorexia and lactic acidosis have also been reported during postmarketing experience.[Ref]

Respiratory

Cough (up to 95%), rhinitis (up to 100%), pharyngitis (up to 56%), respiratory disorder (up to 60%), lung disorder (up to 44%), asthma (up to 45%), epistaxis (up to 28%), hypoventilation (up to 22%), pneumonia (up to 22%), hyperventilation (up to 15%), voice alteration (up to 25%), sinusitis (up to 10%), and stridor (up to 20%) were reported in children; these side effects were not listed for adults.[Ref]

Cardiovascular

Tachycardia (up to 10%) and vasodilation (up to 15%) were reported in children; these side effects were not listed for adults.[Ref]

Hypersensitivity

Allergic reaction has also been reported during postmarketing experience.[Ref]

Oncologic

Endocrine

Ocular

Conjunctivitis (up to 44%), eye disorder (up to 17%), abnormal vision (up to 11%), and conjunctival edema (up to 20%) were reported in children; these side effects were not listed for adults.[Ref]

Genitourinary

Genital pain (up to 17%) and urinary incontinence (up to 11%) were reported in children; these side effects were not listed for adults.[Ref]

Immunologic

Renal

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Further information

Stavudine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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