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Irinotecan Side Effects

For the Consumer

Applies to irinotecan: intravenous solution

Along with its needed effects, irinotecan 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:

More Common

  • Anxiety
  • black, tarry stools
  • blood in the urine or stools
  • blurred vision
  • changes in skin color
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • clay colored stools
  • cold hands and feet
  • confusion
  • constricted pupils
  • cough or hoarseness
  • dark urine
  • diarrhea with or without stomach cramps or sweating
  • dizziness
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • full or bloated feeling or pressure in the stomach
  • headache
  • increased production of saliva
  • increased tear production
  • itching
  • lightheadedness when getting up suddenly from a lying or sitting position
  • loss of appetite
  • low blood pressure or pulse
  • lower back or side pain
  • nausea or vomiting
  • numbness or tingling in the face, arms, or legs
  • pain
  • pain in the chest, groin, or legs, especially calves of the legs
  • pain in the shoulders, arms, jaw, or neck
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • redness or swelling of the leg
  • runny nose
  • severe headache of sudden onset
  • shortness of breath or troubled breathing
  • skin rash
  • slow breathing
  • slurred speech
  • sore throat
  • stomach pain
  • stopping of the heart
  • sudden and severe weakness in the arm or leg on one side of the body
  • sudden loss of coordination
  • sudden vision changes
  • sweating
  • swelling
  • swelling of the abdomen or stomach area
  • temporary blindness
  • tenderness, pain, or swelling of the arm, foot, or leg
  • trouble with speaking or walking
  • ulcers, sores, or white spots on the lips or in the mouth
  • unconsciousness
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • warm, red feeling over the body
  • yellow eyes or skin

Less Common

  • Bleeding gums
  • coughing up blood
  • decreased urination
  • difficulty with swallowing
  • dryness of the mouth
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • sneezing
  • wheezing
  • wrinkled skin


  • Decreased amount of urine
  • decreased frequency of urination
  • fast, irregular, or troubled breathing
  • hives
  • increased blood pressure
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain

Incidence Not Known

  • Abdominal or stomach pain and tenderness
  • agitation
  • bloated or full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coma
  • constipation
  • depression
  • heartburn or indigestion
  • hostility
  • irritability
  • lethargy
  • muscle pain and cramps
  • muscle twitching
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • pain or discomfort in the arms, jaw, back, or neck
  • rectal bleeding
  • severe abdominal or stomach cramping or burning
  • severe and continuing nausea
  • stupor
  • swelling of the face, lower legs, ankles, fingers, or hands
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting of material that looks like coffee grounds

Some side effects of irinotecan 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

  • Acid or sour stomach
  • belching
  • blistering, peeling, redness, or swelling of the palms of hands or bottoms of the feet
  • cracked lips
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • numbness, pain, tingling, or unusual sensations in the palms of hands or bottoms of feet
  • passing gas
  • right upper abdominal or stomach pain and fullness
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • sleeplessness
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unable to sleep
  • weight loss

Incidence Not Known

For Healthcare Professionals

Applies to irinotecan: intravenous solution


"Early" diarrhea usually occurs during or shortly after dosage administration. It may appear as a component of early cholinergic syndrome and may be preceded by complaints of diaphoresis and abdominal cramping. Symptoms may usually be quickly ameliorated by atropine.

Late diarrhea can be prolonged, may lead to dehydration and electrolyte imbalance and can be life threatening. Late diarrhea should be treated promptly with aggressive high dose loperamide therapy. The patient may be treated with 4 mg at the first loose stool or increase in frequency of bowel movements and every 2 hours until the patient is diarrhea-free for 12 hours. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. Administration of irinotecan should be interrupted if severe diarrhea occurs and the dose may need to be reduced.

Ulcerative and ischemic colitis can be complicated by ulceration, bleeding, ileus, obstruction, and infection, including typhlitis. Patients experiencing ileus should receive prompt antibiotic support.[Ref]

Gastrointestinal side effects including "early" diarrhea occurring within 24 hours of the administration of irinotecan (50.7%) and "late" diarrhea occurring over 24 hours after dosage administration (87.8%) have been reported. Nausea (86.2%), vomiting (66.8%), anorexia (54.9%), constipation (29.9%), flatulence (12.2%), stomatitis (11.8%) and dyspepsia (10.5%) have also been reported. Cases of ulcerative and ischemic colitis have been reported infrequently. Intestinal perforation, symptomatic pancreatitis, and asymptomatic elevated pancreatic enzymes have also been reported rarely. Cases of megacolon have been reported in post-marketing experience.[Ref]


Hematologic side effects including leukopenia (63.2%), anemia (60.5%) and neutropenia (53.9%) have been reported.[Ref]

Reduction in neutrophils has been the predominant clinically relevant hematologic effect. The median time to nadir for hematologic values ranges from 14 days for platelets to 21 days for hemoglobin, neutrophils and leukocytes. The median time to nadir for platelets has been reported to have decreased as the starting dose increased.[Ref]


General side effects including asthenia (75.7%), abdominal cramping/pain (56.9%), fever (45.4%), pain (23.7%), headache (16.8%), back pain (14.5%), chills (13.8%), minor infections (14.5%), edema (10.2%) and abdominal enlargement (10.2%) have been reported. Hiccups have been reported in post-marketing experience.[Ref]

Minor infections consisted primarily of upper respiratory infections.[Ref]


Metabolic side effects including loss of body weight (30.3%), dehydration (14.8%), increased alkaline phosphatase (13.2%), and increased SGOT (10.5%) have been reported. Rare cases of hyponatremia (mostly related with diarrhea and vomiting) have also been reported.[Ref]


Dermatologic side effects including alopecia (60.5%), sweating (16.4%), rash (12.8%), and paresthesias have been reported. A case of skin toxicity has also been reported.[Ref]


Interstitial pulmonary disease can be fatal. Risk factors include pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors. Patients with risk factors should be closely monitored for respiratory symptoms before and during irinotecan therapy.[Ref]

Respiratory side effects including dyspnea (22%), increased coughing (17.4%) and rhinitis (15.5%) have been reported. Interstitial pulmonary disease presenting as pulmonary infiltrates has been uncommon during irinotecan therapy. A case of interstitial pneumonia has also been reported.[Ref]

Nervous system

Neurologic side effects including insomnia (19.4%) and dizziness (14.8%) have been reported.[Ref]


Cardiovascular side effects including vasodilation (11.2%) have been reported. Myocardial ischemic events have been observed following irinotecan therapy in post-marketing experience.[Ref]


Hepatic side effects including elevation of hepatic transaminases (8%) have been reported. Transient increase of amylase and occasionally transient increase of lipase have been reported in post-marketing experience.[Ref]


Other side effects including a case of dysarthria have been reported.[Ref]


Hypersensitivity side effects including severe anaphylactic or anaphylactoid reactions have been reported.


Renal side effects have been reported. Infrequent cases of renal insufficiency including acute renal failure, hypotension, or circulatory failure have been observed in patients who experienced episodes of dehydration associated with sepsis, diarrhea, and/or vomiting.


Musculoskeletal side effects including muscular contractions and cramps have been reported.


1. Abigerges D, Chabot GG, Armand JP, Herait P, Gouyette A, Gandia D "Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients." J Clin Oncol 13 (1995): 210-21

2. "Product Information. Camptosar (irinotecan)." Pharmacia and Upjohn, Kalamazoo, MI.

3. Abigerges D, Armand JP, Chabot GG, Da Costa L, Fadel E, Cote C, Herait P, Gandia D "Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea." J Natl Cancer Inst 86 (1994): 446-9

4. Rougier P, Culine S, Bugat R, Brunet P, Douillard JY, Ychou M, Marty M, Bonneterre J, Ganem G, Seitz JF, et al "Multicentric Phase II study of first line CPT-11 (irinotecan) in advanced colorectal cancer (CRC): preliminary results (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 13 (1994): a5851994

5. Hagipantelli R, Saliba F, Misset JL, Giacchetti S, Brain E, Bertheault-Cvitkovic F, Vassal G, Bonnay M, Bastian G, Cote C, et al "Pathophysiology and therapy of irinotecan (CPT-11) induced delayed onset diarrhea (DD): a prospective assessment (Meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 14 (1995): a14991995

6. Michielin O, Udry E, Periard D, Matzinger O, Lobrinus J, Stupp R "Irinotecan-induced interstitial pneumonia." Lancet Oncol 5 (2004): 322-324

7. Baz DV, Bofill JS, Nogueira JA "Irinotecan-induced dysarthria." J Natl Cancer Inst 93 (2001): 1419-20

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.