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

Summary

Common side effects of Doxil include: severe anemia, severe erythrodysesthesia syndrome, nausea, vomiting, diarrhea, stomatitis, erythrodysesthesia syndrome, alopecia, anemia, asthenia, bone marrow depression, neutropenia, thrombocytopenia, and anorexia. Other side effects include: asthma, syncope, severe neutropenia, back pain, chest pain, dyspnea, facial edema, fever, headache, hypotension, pruritus, skin rash, tachycardia, pharyngitis, and chills. Continue reading for a comprehensive list of adverse effects.

Applies to doxorubicin liposomal: intravenous solution.

Serious side effects of Doxil

Along with its needed effects, doxorubicin liposomal (the active ingredient contained in Doxil) 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 doxorubicin liposomal:

More common

• Black, tarry stools
• blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
• blood in the urine or stools
• chills
• cough or hoarseness
• facial swelling
• fever
• headache
• loss of strength and energy
• lower back or side pain
• numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
• painful or difficult urination
• pinpoint red spots on the skin
• shortness of breath
• sore throat
• sores in the mouth and on the lips
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Pain at the injection site
• skin rash or itching

Rare

• Chest pain
• decreased urine output
• dilated neck veins
• extreme fatigue
• irregular breathing
• irregular heartbeat
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• weight gain
• yellowing of the eyes and skin

Other side effects of Doxil

Some side effects of doxorubicin 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

• Creamy white, curd-like patches in mouth or throat
• diarrhea
• loss of appetite
• nausea
• pain when eating or swallowing
• sore throat
• swallowing problems
• vomiting

Less common

• Anxiety
• back pain
• bad, unusual, or unpleasant aftertaste
• burning, dry, or itching eyes
• change in skin color
• constipation
• dizziness
• excessive tearing
• itching
• joint pain
• muscle aches
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• trouble sleeping

Rare

• Abnormal thinking
• change in sense of smell
• chills
• clumsiness, unsteadiness, trembling, or problems with muscle coordination
• cough
• fever
• general feeling of discomfort or illness
• shivering
• sweating

For Healthcare Professionals

Applies to doxorubicin liposomal: intravenous dispersion, intravenous powder for injection.

General

The most common adverse reactions (occurring more than 20% of patients) are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia, and anemia.^[Ref]

Cardiovascular

Common (1% to 10%): Cardiovascular disorder, vasodilatation, hypotension, orthostatic hypotension, flushing, hypertension, phlebitis, ejection fraction decreased, arrhythmia, cardiomyopathy, congestive heart failure, hot flushes, tachycardia, deep vein thrombosis, cardiac arrest

Uncommon (0.1% to 1%): Venous thromboembolism (including thrombophlebitis), venous thrombosis, pericardial effusion^[Ref]

Hematologic

Very common (10% or more): Leucopenia, anemia, neutropenia, thrombocytopenia

Common (1% to 10%): Myelosuppression^[Ref]

Dermatologic

Very common (10% or more): Hand-foot syndrome (51%), rash (29%), alopecia (19%), dry skin, skin discoloration, vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer

Common (1% to 10%): Nail disorder, ecchymosis

Uncommon (0.1% to 1%): Purpura, pruritus, folliculitis

Rare (0.01% to 0.1%): Radiation recall reaction

Very rare (less than 0.01%): Erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis^[Ref]

Gastrointestinal

Very common (10% or more): Constipation, diarrhea, nausea, stomatitis, vomiting

Common (1% to 10%): Pharyngitis, abdominal pain, dyspepsia, mouth ulceration, esophagitis, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion, oral candidiasis, oral moniliasis, glossitis

Uncommon (0.1% to 1%): Dyspepsia, gastric ulcer^[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction^[Ref]

Renal

Common (1% to 10%): Blood creatinine increased^[Ref]

Renal insufficiency has been associated with doxorubicin-induced hyperuricemia (secondary to cell lysis). Adequate hydration, diuresis, and allopurinol can be preventative.

Animal data suggest that doxorubicin may cause glomerular basement membrane injury via production of reactive oxygen species. Administration of some antioxidants, however, have failed to reduce the urinary excretion of lysozyme and N-acetyl-glucosaminidase (markers of tubule injury) in treated animals.^[Ref]

Other

Very common (10% or more): Asthenia, mucous membrane disorder, pain, fever, rigors

Common (1% to 10%): Peripheral edema, chills, malaise, hyperthermia^[Ref]

Oncologic

Postmarketing reports: Secondary oral cancers (primarily squamous cell carcinoma)^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, retinitis^[Ref]

Genitourinary

Common (1% to 10%): Dysuria, vaginitis

Uncommon (0.1% to 1%): Hemorrhagic cystitis, oliguria^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (12%)

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Muscle weakness^[Ref]

Nervous system

Very common (10% or more): Peripheral sensory neuropathy, neuralgia, headache

Common (1% to 10%): Paresthesia, somnolence, peripheral neuropathy, paresthesia, polyneuropathy, dizziness, dysgeusia, lethargy, hypoesthesia, syncope, dysesthesia

Uncommon (0.1% to 1%): Abnormal gait, dysphonia^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, cough, pneumonia, nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis^[Ref]

Metabolic

Very common (10% or more): Anorexia, weight loss

Common (1% to 10%): Dehydration, hypocalcemia

Uncommon (0.1% to 1%): Hyperglycemia^[Ref]

Hepatic

Common (1% to 10%): Aspartate aminotransferase increased, alanine aminotransferase increased^[Ref]

Local

Uncommon (0.1% to 1%): Injection site infection

Very rare (less than 0.01%): Extravasation injury^[Ref]

Immunologic

Very common (10% or more): Neutropenic fever, infections

Common (1% to 10%): Herpes simplex, herpes zoster, influenza-like illness

Uncommon (0.1% to 1%): Sepsis, pneumonitis^[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia, depression

Uncommon (0.1% to 1%): Agitation^[Ref]