Stavudine Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 19, 2024.

Applies to stavudine: oral capsule.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also using didanosine (Videx®).

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have abdominal discomfort or cramping, dark urine, decreased appetite, diarrhea, a general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause you to lose fat from your legs, arms, or face. Talk to your doctor if you have any concerns.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder such as Graves disease, polymyositis, or Guillain-Barré syndrome.

Avoid drinking alcohol or alcoholic beverages while taking this medicine.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

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:

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:

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

• Very common (10% or more): Elevated bilirubin (up to 68%), elevated ALT (up to 65%), elevated AST (up to 63%), elevated GGT (up to 28%), elevated hepatic transaminases (up to 13%)
• Uncommon (0.1% to 1%): Hepatitis/jaundice
• Frequency not reported: Severe hepatomegaly with steatosis, fatal hepatic events, hepatosplenomegaly
• Postmarketing reports: Hepatic steatosis, hepatitis, liver failure, hepatotoxicity resulting in death^[Ref]

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

• Very common (10% or more): Headache (up to 54%), peripheral neurologic symptoms/neuropathy (up to 52%), peripheral neuropathy (up to 24%), dizziness (up to 11%)
• Common (1% to 10%): Paresthesia, peripheral neuritis, somnolence
• Frequency not reported: Peripheral sensory neuropathy, ototoxicity, syncope, encephalopathy, abnormal gait, tremor, hyperkinesia, speech disorder, ear disorder, ear pain, otitis media
• Postmarketing reports: Motor weakness (including severe cases)^[Ref]

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

• Very common (10% or more): Nausea (up to 53%), diarrhea (up to 50%), nausea/vomiting (up to 39%), abdominal pain (up to 34%), vomiting (up to 30%), elevated amylase (up to 31%), elevated lipase (up to 26%), dyspepsia (up to 12%)
• Common (1% to 10%): Pancreatitis (including fatal cases), constipation
• Frequency not reported: Ulcerative stomatitis, melena, tooth caries, dysphagia, aphthous stomatitis, cheilitis, gastrointestinal disorder, glossitis^[Ref]

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

• Very common (10% or more): Chills/fever (up to 50%), asthenia (up to 35%), pain (up to 21%), malaise (up to 20%)
• Common (1% to 10%): Fatigue
• Frequency not reported: Edema, infection, accidental injury, AIDS, death, face edema, mucous membrane disorder, enlarged abdomen, peripheral edema

Antiretroviral therapy:

• Frequency not reported: Increased weight, increased blood lipid levels^[Ref]

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

• Very common (10% or more): Rash (up to 40%), sweating (up to 18%), pruritus (up to 15%)
• Common (1% to 10%): Maculopapular rash, lipoatrophy
• Uncommon (0.1% to 1%): Urticaria
• Frequency not reported: Subcutaneous fat loss, progressive subcutaneous fat wasting, ecchymosis, lesions, vesiculobullous rash, dry skin, skin discoloration, seborrhea, skin disorder, fungal dermatitis, nail disorder, petechial rash, skin ulcer, herpes zoster
• Postmarketing reports: Lipodystrophy^[Ref]

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

• Very common (10% or more): Myalgia (up to 32%), arthralgia (up to 23%), back pain (up to 19%)
• Frequency not reported: Osteonecrosis, muscle weakness, decreased bone mineral density, arthrosis^[Ref]

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

• Very common (10% or more): Insomnia (up to 29%), depression (up to 24%), anxiety (up to 22%), nervousness (up to 12%)
• Common (1% to 10%): Abnormal dreams, abnormal thinking
• Uncommon (0.1% to 1%): Emotional lability
• Frequency not reported: Personality disorder^[Ref]

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

• Very common (10% or more): Lymphadenopathy (up to 20%)
• Common (1% to 10%): Decreased neutrophils, decreased platelets, low hemoglobin
• Postmarketing reports: Anemia, leukopenia, neutropenia, macrocytosis, thrombocytopenia^[Ref]

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

• Very common (10% or more): Anorexia (up to 19%)
• Common (1% to 10%): Asymptomatic hyperlactatemia
• Uncommon (0.1% to 1%): Lactic acidosis (some cases involved motor weakness)
• Frequency not reported: Hyperlipidemia, cachexia, dehydration
• Postmarketing reports: Symptomatic hyperlactatemia, diabetes mellitus, hyperglycemia, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Antiretroviral therapy:

• Frequency not reported: Increased glucose levels^[Ref]

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

• Very common (10% or more): Influenza syndrome (up to 15%), dyspnea (up to 15%)
• Frequency not reported: Cough, rhinitis, pharyngitis, respiratory disorder, lung disorder, asthma, epistaxis, hypoventilation, pneumonia, hyperventilation, voice alteration, sinusitis, stridor^[Ref]

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

• Very common (10% or more): Chest pain (up to 11%)
• Frequency not reported: Tachycardia, vasodilation^[Ref]

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

Hypersensitivity

• Common (1% to 10%): Allergic reactions^[Ref]

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

Oncologic

• Common (1% to 10%): Neoplasms, benign skin neoplasm^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Gynecomastia^[Ref]

Ocular

• Frequency not reported: Conjunctivitis, eye disorder, abnormal vision, conjunctival edema^[Ref]

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

• Frequency not reported: Genital pain, urinary incontinence^[Ref]

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

• Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)^[Ref]

Renal

• Frequency not reported: Fanconi syndrome^[Ref]

See also:

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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