Videx Side Effects Center

Last updated on RxList: 2/7/2023
Videx Side Effects Center

What Is Videx?

Videx (didanosine) also known as ddI, is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Videx is not a cure for HIV or AIDS. Videx is available in generic form.

What Are Side Effects of Videx?

Videx may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • unusual muscle pain,
  • stomach pain,
  • vomiting,
  • irregular heart rate,
  • dizziness,
  • feeling cold,
  • weakness,
  • tiredness,
  • numbness, tingling, or pain in your hands or feet,
  • bloody or tarry stools,
  • coughing up blood,
  • vomit that looks like coffee grounds,
  • vision changes,
  • loss of appetite,
  • upper stomach pain (that may spread to your back)
  • nausea,
  • vomiting,
  • fast heart rate,
  • dark urine,
  • yellowing of the skin or eyes (jaundice),
  • fever,
  • night sweats,
  • swollen glands,
  • cold sores,
  • cough,
  • wheezing,
  • diarrhea,
  • weight loss,
  • trouble speaking or swallowing,
  • problems with balance or eye movements,
  • pricky feeling,
  • swelling in your neck or throat (enlarged thyroid),
  • menstrual changes, and
  • impotence

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Videx 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).

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Videx

The recommended adult total daily dose of Videx is based on body weight, and ranges from 125 mg to 200 mg taken twice daily, or 250 mg to 400 mg taken once daily.

What Drugs, Substances, or Supplements Interact with Videx?

Videx may interact with ganciclovir, hydroxyurea, methadone, stavudine, tenofovir, or antibiotics. Tell your doctor all medications and supplements you use.

Videx During Pregnancy or Breastfeeding

During pregnancy, Videx should be used only when prescribed. It is 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. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Videx (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.

QUESTION

What is HIV? See Answer
Videx Consumer Information

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

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

  • numbness, tingling, or pain in your hands or feet;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • vision changes; or
  • signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Didanosine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • rash;
  • 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.

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A Timeline of the HIV/AIDS Pandemic See Slideshow
Videx Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

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.

Clinical Trials Experience In Adults

Selected clinical adverse reactions that occurred in adult patients in clinical studies with VIDEX are provided in Tables 3 and 4.

Table 3: Selected Clinical Adverse Reactions from Monotherapy Studies

Adverse Reactions Percent of Patients*
ACTG 116A ACTG 116B/117
VIDEX
n=197		 zidovudine
n=212		 VIDEX
n=298		 zidovudine
n=304
Diarrhea 19 15 28 21
Peripheral Neurologic Symptoms/Neuropathy 17 14 20 12
Abdominal Pain 13 8 7 8
Rash/Pruritus 7 8 9 5
Pancreatitis 7 3 6 2
* The incidences reported included all severity grades and all reactions regardless of causality.

Table 4: Selected Clinical Adverse Reactions from Combination Studies

Adverse Reactions Percent of Patientsa,c
AI454-148b START 2b
VIDEX + stavudine + nelfinavir
n=482		 zidovudine + lamivudine + nelfinavir
n=248		 VIDEX + stavudine + indinavir
n=102		 zidovudine + lamivudine + indinavir
n=103
Diarrhea 70 60 45 39
Nausea 28 40 53 67
Peripheral Neurologic Symptoms/Neuropathy 26 6 21 10
Headache 21 30 46 37
Rash 13 16 30 18
Vomiting 12 14 30 35
Pancreatitis (see below) 1 * less than 1 *
a Percentages based on treated subjects.
b Median duration of treatment 48 weeks.
c The incidences reported included all severity grades and all reactions regardless of causality.
* This event was not observed in this study arm.

Pancreatitis resulting in death was observed in one patient who received VIDEX (didanosine) plus stavudine plus nelfinavir in Study AI454-148 and in one patient who received VIDEX plus stavudine plus indinavir in the START 2 study. In addition, pancreatitis resulting in death was observed in 2 of 68 patients who received VIDEX plus stavudine plus indinavir plus hydroxyurea in an ACTG clinical trial [see WARNINGS AND PRECAUTIONS].

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

Selected laboratory abnormalities in clinical studies with VIDEX are shown in Tables 5-7.

Table 5: Selected Laboratory Abnormalities from Monotherapy Studies

Parameter Percent of Patients
ACTG 116A ACTG 116B/117
VIDEX
n=197		 zidovudine
n=212		 VIDEX
n=298		 zidovudine
n=304
SGOT (AST) (greater than 5 x ULN) 9 4 7 6
SGPT (ALT) (greater than 5 x ULN) 9 6 6 6
Alkaline phosphatase (greater than 5 x ULN) 4 1 1 1
Amylase (at least 1.4 x ULN) 17 12 15 5
Uric acid (greater than 12 mg/dL) 3 1 2 1
ULN = upper limit of normal.

Table 6: Selected Laboratory Abnormalities from Combination Studies

Parameter Percent of Patientsa
AI454-148b START 2b
VIDEX + stavudine + nelfinavir
n=482		 zidovudine + lamivudine + nelfinavir
n=248		 VIDEX +
stavudine + indinavir
n=102		 zidovudine + lamivudine + indinavir
n=103
Bilirubin (greater than 2.6 x ULN) less than 1 less than 1 16 8
SGOT (AST) (greater than 5 x ULN) 3 2 7 7
SGPT (ALT) (greater than 5 x ULN) 3 3 8 5
GGT (greater than 5 x ULN) NC NC 5 2
Lipase (greater than 2 x ULN) 7 2 5 5
Amylase (greater than 2 x ULN) NC NC 8 2
ULN = upper limit of normal.
NC = Not Collected.
a Percentages based on treated subjects.
b Median duration of treatment 48 weeks.

Table 7: Selected Laboratory Abnormalities from Combination Studies (All Grades)

Parameter Percent of Patientsa
AI454-148b START 2b
VIDEX + stavudine + nelfinavir
n=482		 zidovudine + lamivudine + nelfinavir
n=248		 VIDEX + stavudine + indinavir
n=102		 zidovudine + lamivudine + indinavir
n=103
Bilirubin 7 3 68 55
SGOT (AST) 42 23 53 20
SGPT (ALT) 37 24 50 18
GGT NC NC 28 12
Lipase 17 11 26 19
Amylase NC NC 31 17
NC = Not Collected.
a Percentages based on treated subjects.
b Median duration of treatment 48 weeks.

Clinical Trials Experience In 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 per m2 per 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 per m2 every 12 hours and in less than 1% of the 274 pediatric patients who received didanosine 90 mg per 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, it is not always possible to reliably estimate their frequency. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to VIDEX, or a combination of these factors.

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

Body as a Whole – alopecia, anaphylactoid reaction, asthenia, chills/fever, pain.

Digestive Disorders – anorexia, dyspepsia, and flatulence.

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

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

Metabolic Disorders – diabetes mellitus, 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].

Read the entire FDA prescribing information for Videx (Didanosine Pediatric Powder for Oral Solution)

Read More »

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

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