Ontak Side Effects

Generic name: denileukin diftitox

Medically reviewed by Drugs.com. Last updated on Jun 21, 2024.

Note: This document provides detailed information about Ontak Side Effects associated with denileukin diftitox. Some dosage forms listed on this page may not apply specifically to the brand name Ontak.

Applies to denileukin diftitox: intravenous injectable, intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Serious and fatal infusion reactions may occur; therefore, patients treated with denileukin diftitox must be managed in a facility equipped and staffed for cardiopulmonary resuscitation.

Treatment with denileukin diftitox should be immediately stopped and permanently discontinued after serious infusion reactions.

Capillary leak syndrome resulting in death may also occur.

Patients weight, edema, blood pressure and serum albumin levels should be monitored prior to and during denileukin diftitox treatment.

Patients should also be monitored for loss of visual acuity and color vision.

Serious side effects of Ontak

Along with its needed effects, denileukin diftitox (the active ingredient contained in Ontak) 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 or nurse immediately if any of the following side effects occur while taking denileukin diftitox:

More common side effects

• back pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• body aches or pain
• chest pain
• confusion
• cough
• difficulty with breathing
• difficulty with moving
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• ear congestion
• fast or irregular heartbeat
• feeling unusually cold
• fever or chills
• headache
• loss of appetite
• loss of strength or energy
• loss of voice
• muscle aching or cramping
• muscle pains or stiffness
• nasal congestion
• nausea
• pain in the joints and muscles
• rapid weight gain
• rash
• runny nose
• shivering
• shortness of breath
• sneezing
• sore throat
• sweating
• swollen joints
• tightness in the chest
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• warmth and flushing of the skin
• wheezing

Less common side effects

• abdominal pain, severe
• black, tarry stools
• blood in the urine or stools
• cloudy urine
• cough or hoarseness accompanied by fever or chills
• headache, severe
• loss of coordination
• lower back or side pain accompanied by fever or chills
• pain in the groin or leg
• painful or difficult urination accompanied by fever or chills
• pinpoint red spots on the skin
• slurring of speech
• sudden vision changes
• swelling or pain at the injection site
• unusual bleeding or bruising
• weakness of the arm and leg

Rare side effects

• dry, puffy skin
• increased heart rate
• weight gain

Other side effects of Ontak

Some side effects of denileukin diftitox 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

• change in taste
• diarrhea
• itching
• loss of taste

Less common

• constipation
• indigestion
• numbness or tingling of the fingers, toes, or face
• runny nose
• trouble with sleeping

For healthcare professionals

Applies to denileukin diftitox: intravenous powder for injection, intravenous solution.

Other adverse events

• Very common (10% or more): Infusion reactions (up to 70.5%), pyrexia (up to 63.6%), rigors (up to 47.3%), fatigue (up to 46.7%), peripheral edema (up to 25.5%), asthenia (up to 18.2%), pain (up to 12.7%), chest pain (up to 12.7%)^[Ref]

Cardiovascular

• Very common (10% or more): Capillary leak syndrome (up to 32.5%), hypotension (up to 16.4%)^[Ref]

Ocular

• Common (1% to 10%): Visual changes (e.g., visual acuity loss)^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 24.4%), pruritus (up to 18.2%)^[Ref]

Endocrine

• Postmarketing reports: Thyroid conditions (hyperthyroidism, thyroiditis, thyrotoxicosis, and hypothyroidism)

Gastrointestinal

• Very common (10% or more): Nausea (up to 60%), vomiting (up to 34.5%), diarrhea (up to 22.2%)^[Ref]

Hepatic

• Very common (10% or more): Increased ALT or increased AST (up to 84%)^[Ref]

Metabolic

• Very common (10% or more): Anorexia (up to 20%)^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (up to 20%), back pain (up to 18.2%), arthralgia (up to 15.6%)^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 28.9%), dizziness (up to 12.7%), dysgeusia (up to 10.9%)^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 20%), upper respiratory tract infection (up to 13.3%), dyspnea (up to 13.3%)^[Ref]

Further information

Ontak 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.

Medical Disclaimer