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Didanosine

Generic Name: didanosine (dye DAN oh seen)
Brand Name: Videx, Videx EC
Physician reviewed didanosine patient information - includes didanosine description, dosage and directions.
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Drug Information:
Didanosine is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Didanosine is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Didanosine is not a cure for HIV or AIDS. Didanosine is for use in adults and children who are at least 2 weeks old. Didanosine may also be used for purposes not listed in this medication guide. Do not take didanosine together with Allopurinol, Ribavirin, or Stavudine. You may develop Lactic Acidosis, a dangerous build-up of Lactic Acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired. Learn more

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Didanosine Side Effects

In Summary

More frequently reported side effects include: pancreatitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to didanosine: oral capsule delayed release, oral powder for suspension

Warning

Oral route (Capsule, Delayed Release; Powder for Solution)

Warning: Pancreatitis, Lactic Acidosis and Hepatomegaly with SteatosisFatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis.Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents.Coadministration of didanosine and stavudine 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 occurs

Along with its needed effects, didanosine 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 didanosine:

Less common

  • Nausea
  • stomach pain
  • tingling, burning, numbness, and pain in the hands or feet
  • vomiting

Rare

  • Chills
  • fever
  • itching, skin rash
  • seizures
  • sore throat
  • swelling of the feet or lower legs
  • unusual bleeding and bruising
  • unusual tiredness and weakness
  • yellow skin and eyes

Incidence not known

  • Anxiety
  • black, tarry stools
  • bleeding gums
  • blindness
  • bloating
  • blood in the urine or stools
  • blue-yellow color blindness
  • blurred vision
  • change in the color of the eye
  • chest pain
  • clay colored stools
  • cold sweats
  • confusion
  • constipation
  • cool, pale skin
  • cough
  • dark urine
  • decreased appetite
  • decreased vision
  • depression
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • dry eyes or mouth
  • eye pain
  • fast heartbeat
  • fast, shallow breathing
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort
  • headache
  • hives
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • joint pain
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • muscle aching, cramping, or pain
  • nightmares
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • right upper abdominal or stomach pain and fullness
  • shakiness
  • sleepiness
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach ache or discomfort
  • sweating
  • swollen glands or joints
  • tightness in the chest
  • troubled breathing with exertion
  • unexplained weight loss
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

Some side effects of didanosine 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

  • Difficulty with sleeping
  • irritability
  • restlessness

Incidence not known

  • Belching
  • excess air or gas in the stomach or bowels
  • feeling of fullness
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • lack or loss of strength
  • passing gas

For Healthcare Professionals

Applies to didanosine: oral delayed release capsule, oral powder for reconstitution, oral tablet chewable

General

The most common side effects were diarrhea, peripheral neurologic symptoms/neuropathy, abdominal pain, nausea, headache, rash, and vomiting. Significant toxicities included pancreatitis, lactic acidosis/severe hepatomegaly with steatosis, retinal changes, optical neuritis, and peripheral neuropathy.

Gastrointestinal

Very common (10% or more): Diarrhea (up to 70%), nausea (up to 53%), elevated amylase (up to 31%), vomiting (up to 30%), elevated lipase (up to 26%), abdominal pain (up to 13%)

Common (1% to 10%): Pancreatitis

Postmarketing reports: Dyspepsia, flatulence, pancreatitis (including fatal cases), dry mouth, sialoadenitis, parotid gland enlargement, increased/abnormal serum amylase

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 7%; all grades: up to 26%) were reported; grades 3 to 4 amylase and lipase elevations were greater than 2 times the upper limit of normal (2 x ULN).

In monotherapy trials, elevated amylase (at least 1.4 x ULN) was reported in up to 17% of patients.

Pancreatitis resulting in death has been reported during clinical trials of this drug in combination with other antiretroviral agents. The frequency of pancreatitis was dose-related. In phase 3 trials with buffered formulations, incidence ranged from 1% to 10% with doses higher than currently recommended and 1% to 7% with recommended doses.

Hepatic

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 monotherapy trials, elevated AST (greater than 5 x ULN) and ALT (greater than 5 x ULN) were each reported in up to 9% of patients.

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 hepatic events were reported most often in patients treated with this drug in combination with hydroxyurea and stavudine.

Very common (10% or more): Elevated bilirubin (up to 68%), elevated AST (up to 53%), elevated ALT (up to 50%), elevated GGT (up to 28%)

Frequency not reported: Severe hepatomegaly with steatosis, hepatic toxicity, fatal hepatic events, fulminant hepatitis (including fatal cases)

Postmarketing reports: Hepatic steatosis, noncirrhotic portal hypertension, hepatitis, liver failure

Nervous system

Neuropathy presented as tingling, numbness, or pain in the hands or soles of the feet which progressed up the legs. The incidence was higher in patients with history of neuropathy and/or low CD4+ cell counts (less than 50 cells/mm3). Following discontinuation of this drug, neuropathy usually resolved within 2 to 12 weeks.

Very common (10% or more): Headache (up to 46%), peripheral neurologic symptoms/neuropathy (up to 26%)

Frequency not reported: Seizures

Dermatologic

Very common (10% or more): Rash (up to 30%)

Common (1% to 10%): Rash/pruritus

Frequency not reported: Lipoatrophy/subcutaneous fat loss, cutaneous leukocytoclastic vasculitis

Postmarketing reports: Alopecia

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.

Other

In monotherapy trials, elevated alkaline phosphatase (greater than 5 x ULN) was reported in up to 4% of patients.

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Increased alkaline phosphatase

Frequency not reported: Edema

Postmarketing reports: Asthenia, chills/fever, pain, increased/abnormal alkaline phosphatase

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipid levels

Hematologic

Common (1% to 10%): Neutropenia

Uncommon (0.1% to 1%): Anemia, thrombocytopenia

Frequency not reported: Splenomegaly

Postmarketing reports: Leukopenia, granulocytopenia

Thrombocytopenia and splenomegaly have been reported as early signs of noncirrhotic portal hypertension.

Anemia and thrombocytopenia have also been reported during postmarketing experience.

Metabolic

Common (1% to 10%): Elevated serum uric acid

Frequency not reported: Hyperuricemia, hypertriglyceridemia, impaired glucose tolerance, insulin-dependent diabetes mellitus, acute gouty arthritis

Postmarketing reports: Anorexia, symptomatic hyperlactatemia/lactic acidosis, diabetes mellitus, hypoglycemia, hyperglycemia

Antiretroviral therapy:

-Frequency not reported: Increased glucose levels

In monotherapy trials, elevated uric acid (greater than 12 mg/dL) was reported in up to 3% of patients.

Hyperlactatemia appeared to be more common with this drug while lactic acidosis was an infrequent occurrence.

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 stavudine with other antiretroviral agents.

In a report following patients on combined therapy with this drug and tenofovir, 1 patient developed didanosine-related toxicity characterized by lactic acidosis with liver failure after 3 months using 200 mg/day of this drug with tenofovir.

In 1 case report, acute gouty arthritis developed 14 weeks after this drug was added to the treatment regimen of a patient receiving ritonavir, both known to infrequently cause hyperuricemia. The symptoms resolved upon discontinuation of this drug and a short course of indomethacin.

Psychiatric

Frequency not reported: Insomnia, restlessness

Ocular

Frequency not reported: Retinal changes, optic neuritis, diffuse dysfunction of the retinal epithelium with bilateral visual deficit (including night blindness and a peripheral visual fold reduction)

Postmarketing reports: Dry eyes, retinal depigmentation

Diffuse dysfunction of the retinal epithelium has been reported in 2 patients during therapy with this drug. Both patients experienced bilateral visual deficit including night blindness and a peripheral visual fold reduction. Symptoms were first noted after 31 and 34 weeks of therapy. Deficits in both patients appeared to be partially reversible upon discontinuation of this drug.

Optic neuritis has also been reported during postmarketing experience.

Musculoskeletal

Frequency not reported: Osteonecrosis

Postmarketing reports: Myalgia (with or without increased creatine phosphokinase), rhabdomyolysis (including acute renal failure and hemodialysis), arthralgia, myopathy, increased/abnormal creatine phosphokinase

Hypersensitivity

Postmarketing reports: Anaphylactoid/anaphylactic reaction

Immunologic

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

Endocrine

Postmarketing reports: Gynecomastia

Respiratory

Frequency not reported: Dyspnea, orthopnea

Cardiovascular

Frequency not reported: Cardiomyopathy aggravated, pericarditis, left ventricular failure

Underlying cardiomyopathy may have been aggravated by treatment with buffered formulations, which had high sodium content.

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Didanosine (www.drugs.com/mtm/didanosine.html).