Skip to main content

Doxil Side Effects

Generic name: doxorubicin liposomal

Medically reviewed by Drugs.com. Last updated on Nov 3, 2023.

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.

Applies to doxorubicin liposomal: intravenous solution.

Warning

Intravenous route (Solution)

DOXOrubicin hydrochloride (HCl) liposome injection can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 to 550 mg/m(2). Assess left ventricular cardiac function prior to initiation of DOXOrubicin HCl liposome and during and after treatment. Serious, life-threatening and fatal infusion-related reactions can occur with DOXOrubicin HCl liposome. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXOrubicin HCl liposome for infusion-related reactions and resume at a reduced rate. Discontinue DOXOrubicin HCl liposome for serious or life-threatening infusion-related reactions.

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

Less common

Rare

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

Less common

Rare

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]

Frequently asked questions

References

1. Product Information. Adriamycin PFS (doxorubicin). Pharmacia and Upjohn. 2001;PROD.

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

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. DOXOrubicin Liposomal (doxorubicin liposomal). Caraco Pharmaceutical Laboratories. 2018.

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.