Leukeran (Chlorambucil) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Aspen Global Inc. Toll-Free at 1-855-800-8165 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Hematologic

The most common side effect is bone marrow suppression, anemia, leukopenia, neutropenia, thrombocytopenia, or pancytopenia. Although bone marrow suppression frequently occurs, it is usually reversible if the chlorambucil is withdrawn early enough. However, irreversible bone marrow failure has been reported.

Gastrointestinal

Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral ulceration occur infrequently.

CNS

Tremors, muscular twitching, myoclonia, confusion, agitation, ataxia, flaccid paresis, and hallucinations have been reported as rare adverse experiences to chlorambucil which resolve upon discontinuation of drug. Rare, focal and/or generalized seizures have been reported to occur in both children and adults at both therapeutic daily doses and pulse-dosing regimens, and in acute overdose (see PRECAUTIONS: General).

Dermatologic

Allergic reactions such as urticaria and angioneurotic edema have been reported following initial or subsequent dosing. Skin hypersensitivity (including rare reports of skin rash progressing to erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome) has been reported (see WARNINGS).

Miscellaneous

Other reported adverse reactions include: pulmonary fibrosis, hepatotoxicity and jaundice, drug fever, peripheral neuropathy, interstitial pneumonia, sterile cystitis, infertility, leukemia, and secondary malignancies (see WARNINGS).

REPORTS OF SUSPECTED LEUKERAN SIDE EFFECTS / ADVERSE REACTIONS

Possible Leukeran side effects / adverse reactions in 48 year old female

Reported by a physician from United States on 2011-10-19

Patient: 48 year old female

Reactions: Squamous Cell Carcinoma of Skin

Suspect drug(s):
Arava
    Indication: Behcet's Syndrome

Colchicine
    Indication: Behcet's Syndrome

Cyclosporine
    Indication: Behcet's Syndrome

Cytoxan
    Indication: Behcet's Syndrome

Dapsone
    Indication: Behcet's Syndrome

Enbrel
    Indication: Behcet's Syndrome

Imuran
    Indication: Behcet's Syndrome

Leukeran
    Indication: Behcet's Syndrome

Methotrexate
    Indication: Behcet's Syndrome

Mycophenolate Mofetil (Cellcept)
    Indication: Behcet's Syndrome

Plaquenil
    Indication: Behcet's Syndrome

Prednisone
    Indication: Behcet's Syndrome

Remicade
    Indication: Behcet's Syndrome

Rituxan
    Indication: Behcet's Syndrome

Other drugs received by patient: Pregabalin; Acyclovir; Folic Acid; Furosemide; Terbutaline Sulfate; Erythromycin; Esomeprazole Sodium; Pentoxifylline; Theophylline; Fentanyl-100; Fluticasone Propionate/salmeterol; Sertraline Hydrochloride

Possible Leukeran side effects / adverse reactions in 48 year old female

Reported by a physician from United States on 2011-10-28

Patient: 48 year old female

Reactions: Renal Failure, Nausea, Mouth Ulceration, Anaemia, Squamous Cell Carcinoma of Skin, Neutropenia, Rash, Accidental Exposure

Suspect drug(s):
Arava
    Dosage: 20 mg daily
    Indication: Behcet's Syndrome

Cellcept
    Dosage: 1000 mg twice daily
    Indication: Behcet's Syndrome

Colchicine
    Dosage: 6 mg twice daily, 6 mg twice daily
    Indication: Behcet's Syndrome

Cyclosporine
    Indication: Behcet's Syndrome
    End date: 2001-01-06

Cytoxan
    Dosage: 250 mg, 250 mg, 500 mg, 750 mg, 1000 mg, 1250 mg, intravenous
    Indication: Behcet's Syndrome

Dapsone
    Dosage: titrated up to 100 mg twice daily, titrated up to 50 mg daily
    Indication: Behcet's Syndrome

Enbrel
    Dosage: 25 mg twice weekly
    Indication: Behcet's Syndrome

Imuran
    Dosage: titrated up to 150 mg daily
    Indication: Behcet's Syndrome

Leukeran
    Dosage: titrated up to 4 mg daily, 3 mg daily, 3 mg daily
    Indication: Behcet's Syndrome

Methotrexate
    Dosage: 7.5 mg per week, titrated up to 20 mg per week
    Indication: Behcet's Syndrome

Plaquenil
    Dosage: 300 mg daily, 200 mg daily, 200 mg twice daily, oral
    Administration route: Oral
    Indication: Behcet's Syndrome

Prednisone
    Dosage: 10 mg daily
    Indication: Behcet's Syndrome

Remicade
    Dosage: 200 mg, 300 mg, 400 mg, intravenous
    Indication: Behcet's Syndrome

Rituxan
    Dosage: 1000 mg, 1000 mg, intravenous
    Indication: Behcet's Syndrome
    End date: 2006-07-05

Other drugs received by patient: Terbutaline Sulfate; (Esomeprazole); Pregabalin; Acyclovir; (Fentanyl); Erythromycin; Sertraline Hydrochloride; Theophylline; Pentoxifylline; Furosemide; Folic Acid; Fluticasone Propionate/salmeterol; Ipratropium Bromide and Albuterol Sulfate

Possible Leukeran side effects / adverse reactions in 48 year old female

Reported by a physician from United States on 2011-12-13

Patient: 48 year old female

Reactions: Squamous Cell Carcinoma of Skin

Suspect drug(s):
Arava
    Dosage: 20 mg, daily
    Start date: 2007-06-01

Cellcept
    Dosage: 1000 mg, 2x/day
    Indication: Behcet's Syndrome
    Start date: 2001-01-01
    End date: 2001-09-01

Colchicine
    Dosage: 6 mg, 2x/day
    Indication: Behcet's Syndrome
    Start date: 1999-10-01
    End date: 2002-12-01

Colchicine
    Dosage: 6 mg, 2x/day
    Start date: 2004-08-01

Cyclosporine
    Dosage: unk
    Indication: Behcet's Syndrome
    Start date: 2000-05-01
    End date: 2001-01-06

Cytoxan
    Dosage: 500 mg, unk
    Start date: 2003-01-01

Cytoxan
    Dosage: 1250 mg, unk
    Start date: 2003-03-01

Cytoxan
    Dosage: 500 mg, unk
    Start date: 2003-05-01

Cytoxan
    Dosage: 1000 mg, unk
    Start date: 2003-09-01

Cytoxan
    Dosage: 750 mg, unk
    Start date: 2003-08-01

Cytoxan
    Dosage: 250 mg, unk
    Start date: 2002-12-01

Cytoxan
    Dosage: 500 mg, unk
    End date: 2004-05-01

Cytoxan
    Dosage: 750 mg, unk
    Start date: 2003-02-01

Cytoxan
    Dosage: 1000 mg, unk
    Start date: 2003-03-01

Cytoxan
    Dosage: 500 mg, unk
    Start date: 2003-07-01

Cytoxan
    Dosage: 1250 mg, unk
    Start date: 2003-04-01

Dapsone
    Dosage: 50 mg, daily
    Start date: 2003-06-01
    End date: 2005-09-01

Dapsone
    Dosage: 100 mg, 2x/day
    Indication: Behcet's Syndrome
    Start date: 1999-09-01
    End date: 2000-05-01

Enbrel
    Dosage: 25 mg, 2x/week
    Indication: Ankylosing Spondylitis
    Start date: 2004-09-01
    End date: 2005-02-01

Imuran
    Dosage: 150 mg, daily
    Indication: Behcet's Syndrome
    Start date: 2005-02-01
    End date: 2005-04-01

Imuran
    Dosage: 150 mg, daily
    Start date: 2007-01-01
    End date: 2007-03-01

Leukeran
    Dosage: 2 mg, unk
    Start date: 2002-06-01
    End date: 2002-09-01

Leukeran
    Dosage: 4 mg, daily
    Indication: Behcet's Syndrome
    Start date: 2001-11-01

Leukeran
    Dosage: 3 mg, unk
    Start date: 2002-04-01

Methotrexate
    Dosage: titrated from 7.5 mg up to 20 mg weekly
    Indication: Behcet's Syndrome
    Start date: 1998-10-01
    End date: 1999-07-01

Plaquenil
    Dosage: 300 mg, qd
    Indication: Behcet's Syndrome
    Start date: 1999-07-01
    End date: 2002-01-01

Plaquenil
    Dosage: 200 mg, 2x/day
    Start date: 2004-08-01

Plaquenil
    Dosage: 200 mg, daily
    Start date: 2002-06-01

Prednisone TAB
    Dosage: 10 mg, daily, occasional pulses
    Indication: Behcet's Syndrome

Remicade
    Dosage: 400 mg, unk
    Start date: 2005-05-01

Remicade
    Dosage: 300 mg, unk
    Start date: 2005-07-01

Remicade
    Dosage: 400 mg, unk
    Start date: 2005-11-01

Remicade
    Dosage: 400 mg, unk
    Start date: 2006-01-01
    End date: 2006-02-01

Remicade
    Dosage: 200 mg, unk
    Indication: Behcet's Syndrome
    Start date: 2005-04-01

Remicade
    Dosage: 400 mg, unk
    Start date: 2005-09-01

Rituxan
    Dosage: 1000 mg, unk
    Indication: Behcet's Syndrome
    Start date: 2006-06-01

Rituxan
    Dosage: 1000 mg, unk
    Start date: 2006-07-05

Other drugs received by patient: Fentanyl; Galenic /fluticasone/salmeterol/; Acyclovir; Folic Acid; Terbutaline Sulfate; Albuterol Sulfate and Ipratropium Bromide; Theophylline; Erythromycin; Esomeprazole Magnesium; Sertraline Hydrochloride; Furosemide; Pentoxifylline; Pregabalin