Skip to main content

Onivyde Side Effects

Generic name: irinotecan liposomal

Medically reviewed by Last updated on Oct 28, 2023.

Note: This document contains side effect information about irinotecan liposomal. Some dosage forms listed on this page may not apply to the brand name Onivyde.

Applies to irinotecan liposomal: intravenous solution.


Intravenous route (Solution)

Fatal neutropenic sepsis occurred in 0.8% of patients receiving irinotecan liposome. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving irinotecan liposome in combination with fluorouracil and leucovorin. Withhold irinotecan liposome for absolute neutrophil count below 1500/mm(3) or neutropenic fever. Monitor blood cell counts periodically during treatment.Severe diarrhea occurred in 13% of patients receiving irinotecan liposome in combination with fluorouracil and leucovorin. Do not administer irinotecan liposome to patients with bowel obstruction. Withhold irinotecan liposome for diarrhea of Grade 2 to 4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.

Serious side effects of Onivyde

Along with its needed effects, irinotecan liposomal (the active ingredient contained in Onivyde) 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 irinotecan liposomal:

More common

  • Confusion
  • decreased urination
  • diarrhea (severe)
  • dizziness
  • dry mouth
  • fainting
  • fever
  • lightheadedness
  • pale skin
  • rapid breathing
  • sunken eyes
  • thirst
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wrinkled skin

Less common

  • Black, tarry stools
  • chest pain or discomfort
  • chills
  • confusion
  • cough
  • fast heartbeat
  • lightheadedness, dizziness, or fainting
  • lower back or side pain
  • painful or difficult urination
  • rapid, shallow breathing
  • slow or irregular heartbeat
  • sore throat
  • trouble breathing
  • ulcers, sores, or white spots in the mouth

Incidence not known

  • Chest tightness
  • hives, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddening of the skin, especially around the ears

Other side effects of Onivyde

Some side effects of irinotecan liposomal 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

  • Decreased appetite
  • hair loss or thinning of the hair
  • lack or loss of strength
  • vomiting
  • weight loss

Less common

  • Feeling of warmth
  • increased sweating
  • sneezing
  • stomach pain
  • stuffy or runny nose
  • tearing of the eyes
  • watering of the mouth
  • weakness

For Healthcare Professionals

Applies to irinotecan liposomal: intravenous dispersion.


Very common (10% or more): Diarrhea (70%), nausea (61%), vomiting (54%), abdominal pain (34%), constipation (18%), stomatitis, mucosal inflammation

Common (1% to 10%): Gastroenteritis, oral candidiasis, colitis, hemorrhoids

Uncommon (0.1% to 1%): Esophagitis, proctitis[Ref]


Very common (10% or more): Alopecia (22%)

Uncommon (0.1% to 1%): Rash maculopapular, nail discoloration[Ref]


Very common (10% or more): Anemia (33%), neutropenia (15%), leukopenia, thrombocytopenia

Common (1% to 10%): Lymphopenia, febrile neutropenia

Uncommon (0.1% to 1%): Biliary sepsis[Ref]


Common (1% to 10%): Hypoalbuminemia, increased bilirubin, increased alanine aminotransferase, increased aspartate aminotransferase, increased international normalized ratio[Ref]


Common (1% to 10%): Infusion related reaction[Ref]


Very common (10% or more): Decreased appetite (49%), weight loss (20%), hypokalemia, hypomagnesemia, dehydration

Common (1% to 10%): Hypoglycemia, hyponatremia, hypophosphatemia, dehydration[Ref]

Nervous system

Very common (10% or more): Dizziness (12%)

Common (1% to 10%): Cholinergic syndrome, dysgeusia[Ref]


Very common (10% or more): Fatigue (37%), asthenia (24%), pyrexia (20%), enema peripheral (19%)[Ref]


Common (1% to 10%): Acute renal failure[Ref]


Common (1% to 10%): Septic shock, sepsis[Ref]


Common (1% to 10%): Back pain[Ref]


Common (1% to 10%): Insomnia[Ref]


Common (1% to 10%): Pneumonia, pulmonary embolism, embolism, dyspnea, dysphonia[Ref]


Common (1% to 10%): Hypotension, deep vein thrombosis

Uncommon (0.1% to 1%): Thrombosis[Ref]


1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Onivyde (irinotecan liposomal). Merrimack Pharmaceuticals. 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.