Leustatin Side Effects
Generic name: cladribine
Medically reviewed by Drugs.com. Last updated on Jun 28, 2022.
Note: This document contains side effect information about cladribine. Some of the dosage forms listed on this page may not apply to the brand name Leustatin.
For the Consumer
Applies to cladribine: oral tablet
Other dosage forms:
Oral route (Tablet)
MalignancyTreatment with cladribine may increase the risk of malignancy. Cladribine is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine on an individual patient basis. Follow standard cancer screening guidelines in patients treated with cladribine.Risk of TeratogenicityCladribine is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with cladribine in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course. Stop cladribine if the patient becomes pregnant.
Side effects requiring immediate medical attention
Along with its needed effects, cladribine (the active ingredient contained in Leustatin) 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 immediately if any of the following side effects occur while taking cladribine:
- Body aches or pain
- ear congestion
- fast heartbeat
- hives, itching, skin rash
- joint pain, stiffness, or swelling
- loss of voice
- lower back or side pain
- painful or difficult urination
- redness of the skin
- runny or stuffy nose
- sore throat
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled breathing or swallowing
- unusual tiredness or weakness
- Blurred vision
- cough producing mucus
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- pounding in the ears
- slow heartbeat
- trouble concentrating
- trouble sleeping
- Burning or stinging of the skin
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- stiff neck
Incidence not known
- Blistering, peeling, loosening of the skin
- chest pain
- muscle pain
- red skin lesions, often with a purple center
- red, irritated eyes
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- unusual bleeding or bruising
Side effects not requiring immediate medical attention
Some side effects of cladribine 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:
- Back pain
- difficulty in moving
- muscle stiffness
- trouble sleeping
- Thinning or loss of hair
For Healthcare Professionals
Applies to cladribine: intravenous solution, oral tablet
Common (1% to 10%): Febrile neutropenia
Common (1% to 10%): Renal impairment, renal failure
Very common (10% or more): Nausea (28%), anorexia (17%), vomiting (13%), diarrhea (10%)
Very common (10% or more): Rash (28%), diaphoresis, pruritus
Very common (10% or more): Headache
Common (1% to 10%): Dizziness, somnolence
Uncommon (0.1% to 1%): Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy (paralysis), polyneuropathy, paraparesis)[Ref]
Very common (10% or more): Administration site reaction[Ref]
Common (1% to 10%): Weight loss
Common (1% to 10%): Arthralgia, myalgia
Uncommon (0.1% to 1%): Muscular weakness, paraparesis[Ref]
Very common (10% or more): Cough
Common (1% to 10%): Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis), abnormal breath sounds, abnormal chest sounds, dyspnea, rales[Ref]
Common (1% to 10%): Hypersensitivity[Ref]
Very common (10% or more): Infection (unspecified) (up to 28%)
Very common (10% or more): Fatigue, pyrexia, pain
Common (1% to 10%): Asthenia, chills, malaise, localized edema, chills[Ref]
Postmarketing reports: Secondary malignancies[Ref]
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More about Leustatin (cladribine)
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Reviews (1)
- En español
- Drug class: antimetabolites
Related treatment guides
1. "Product Information. Leustatin (cladribine)." Ortho Biotech Inc (2001):
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp." (2006):
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.