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Videx EC

Last reviewed on RxList: 12/28/2016
Videx EC Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/16/2016

Videx EC (didanosine) is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Videx EC is not a cure for HIV or AIDS. Videx EC is available in generic form. Common side effects of Videx EC include:

  • headache
  • diarrhea
  • mild skin rash, or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist)

The recommended total daily dose of Videx EC ranges from 200 to 400 mg, taken once-daily. Dosage is based on body weight. Videx EC may interact with ganciclovir, hydroxyurea, methadone, stavudine, or tenofovir. Tell your doctor all medications and supplements you use. During pregnancy, Videx EC should be used only when prescribed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Videx EC (didanosine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Videx EC Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Didanosine 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;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • fast or uneven heart rate.

Stop using didanosine and call your doctor at once if you have any of these other serious side effects:

  • signs of a new infection such as 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;
  • itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling around your stomach, feeling of fullness, feeling short of breath, coughing up blood;
  • numbness, tingling, or pain in your hands or feet;
  • pain in one or both eyes, vision problems, seeing flashes of light;
  • pale skin, easy bruising or bleeding, feeling light-headed, rapid heart rate, trouble concentrating;
  • 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 or prickly feeling in your fingers or toes;
  • problems with walking, breathing, speech, swallowing, or eye movement; or
  • severe lower back pain, loss of bladder or bowel control.

Less serious side effects may include:

  • mild skin rash;
  • diarrhea;
  • headache; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Videx EC (Didanosine Delayed-Release Capsules)

Videx EC Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

Study AI454-152 was a 48-week, randomized, open-label study comparing VIDEX EC (400 mg once daily) plus stavudine (40 mg twice daily) plus nelfinavir (750 mg three times daily) to zidovudine (300 mg) plus lamivudine (150 mg) combination tablets twice daily plus nelfinavir (750 mg three times daily) in 511 treatment-naive patients. Selected clinical adverse reactions that occurred in combination with other antiretroviral agents are provided in Table 3.

Table 3: Selected Clinical Adverse Reactions, Study AI454-152a

Adverse Reactions Percent of Patientsb,c
VIDEX EC + stavudine + nelfinavir
n=258
zidovudine/lamivudined +nelfinavir
n=253
Diarrhea 57 58
Peripheral Neurologic Symptoms/Neuropathy 25 11
Nausea 24 36
Headache 22 17
Rash 14 12
Vomiting 14 19
Pancreatitis (see below) less than 1 *
a Median duration of treatment was 62 weeks in the VIDEX EC + stavudine + nelfinavir group and 61 weeks in the zidovudine/lamivudine + nelfinavir group.
b Percentages based on treated patients.
c The incidences reported included all severity grades and all reactions regardless of causality.
d Zidovudine/lamivudine combination tablet.
* This event was not observed in this study arm.

In clinical trials using a buffered formulation of didanosine, pancreatitis resulting in death was observed in one patient who received didanosine plus stavudine plus nelfinavir, one patient who received didanosine plus stavudine plus indinavir, and 2 of 68 patients who received didanosine plus stavudine plus indinavir plus hydroxyurea. In an early access program, pancreatitis resulting in death was observed in one patient who received VIDEX EC plus stavudine plus hydroxyurea plus ritonavir plus indinavir plus efavirenz [see WARNINGS AND PRECAUTIONS].

The frequency of pancreatitis is dose related. In phase 3 studies with buffered formulations of didanosine, incidence ranged from 1% to 10% with doses higher than are currently recommended and 1% to 7% with recommended dose.

Selected laboratory abnormalities that occurred in a study of VIDEX EC in combination with other antiretroviral agents are shown in Table 4.

Table 4: Selected Laboratory Abnormalities, Study AI454-152a

Parameter Percent of Patientsb
VIDEX EC + stavudine+ nelfinavir
n=258
zidovudine/lamivudinec +nelfinavir
n=253
Grades 3-4d All Grades Grades 3-4d All Grades
SGOT (AST) 5 46 5 19
SGPT (ALT) 6 44 5 22
Lipase 5 23 2 13
Bilirubin less than 1 9 less than 1 3
a Median duration of treatment was 62 weeks in the VIDEX EC + stavudine + nelfinavir group and 61 weeks in the zidovudine/lamivudine + nelfinavir group.
b Percentages based on treated patients.
c Zidovudine/lamivudine combination tablet.
d Greater than 5 x ULN for SGOT and SGPT, at least 2.1 x ULN for lipase, and at least 2.6 x ULN for bilirubin (ULN = upper limit of normal).

Pediatric Patients

In clinical trials, 743 pediatric patients between 2 weeks and 18 years of age have been treated with didanosine. Adverse reactions and laboratory abnormalities reported to occur in these patients were generally consistent with the safety profile of didanosine in adults.

In pediatric phase 1 studies, pancreatitis occurred in 2 of 60 (3%) patients treated at entry doses below 300 mg/m²/day and in 5 of 38 (13%) patients treated at higher doses. In study ACTG 152, pancreatitis occurred in none of the 281 pediatric patients who received didanosine 120 mg/m² every 12 hours and in less than 1% of the 274 pediatric patients who received didanosine 90 mg/m² every 12 hours in combination with zidovudine [see Clinical Studies].

Retinal changes and optic neuritis have been reported in pediatric patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of didanosine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to didanosine, or a combination of these factors.

Blood and Lymphatic System Disorders - anemia, leukopenia, and thrombocytopenia.

Body as a Whole - abdominal pain, alopecia, anaphylactoid reaction, asthenia, chills/fever, pain, and redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Digestive Disorders - anorexia, dyspepsia, and flatulence.

Exocrine Gland Disorders - pancreatitis (including fatal cases) [see WARNINGS AND PRECAUTIONS], sialoadenitis, parotid gland enlargement, dry mouth, and dry eyes.

Hepatobiliary Disorders - symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS]; non-cirrhotic portal hypertension [see WARNINGS AND PRECAUTIONS]; hepatitis and liver failure.

Metabolic Disorders - diabetes mellitus, elevated serum alkaline phosphatase level, elevated serum amylase level, elevated serum gamma-glutamyltransferase level, elevated serum uric acid level, hypoglycemia, and hyperglycemia.

Musculoskeletal Disorders - myalgia (with or without increases in creatine kinase), rhabdomyolysis including acute renal failure and hemodialysis, arthralgia, and myopathy.

Ophthalmologic Disorders - retinal depigmentation and optic neuritis [see WARNINGS AND PRECAUTIONS].

Use with Stavudine- and Hydroxyurea-Based Regimens

When didanosine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when didanosine is used alone. Thus, patients treated with VIDEX EC in combination with stavudine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see WARNINGS AND PRECAUTIONS]. The combination of VIDEX EC and hydroxyurea, with or without stavudine, should be avoided.

Read the entire FDA prescribing information for Videx EC (Didanosine Delayed-Release Capsules)

Related Resources for Videx EC

© Videx EC Patient Information is supplied by Cerner Multum, Inc. and Videx EC Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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