Doxil Side Effects
Generic name: doxorubicin liposomal
Medically reviewed by Drugs.com. Last updated on Nov 12, 2024.
Note: This document provides detailed information about Doxil Side Effects associated with doxorubicin liposomal. Some dosage forms listed on this page may not apply specifically to the brand name Doxil.
Applies to doxorubicin liposomal: intravenous solution.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check you at regular visits while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are receiving this medicine and for 6 months after treatment to keep from getting pregnant. If you think you or your partner have become pregnant, tell your doctor right away.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Check with your doctor right away if you have chest pain or discomfort, a fast or irregular heartbeat, swelling of the feet and lower legs, or troubled breathing. These could be symptoms of a serious heart problem.
This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest tightness, a cough, dizziness, a fast heartbeat, trouble breathing, trouble swallowing, swelling in your face or hands, a fever or chills, or lightheadedness or faintness while you are receiving this medicine.
This medicine may cause hand-foot syndrome. Check with your doctor right away if you have tingling or burning, redness, swelling, blistering, or small sores on the palms of your hands or soles of your feet.
Doxorubicin liposome can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury can occur.
If you continue to receive this medicine for a full year, tell your doctor right away if you have any discomfort, pain, sores or ulcers in your mouth. These could be symptoms of oral cancer.
Tell your doctor right away if you notice redness, pain, or swelling at the injection site after you receive this medicine. If doxorubicin liposome accidentally leaks out of the vein where it is injected, it may damage the skin and cause scars.
This medicine may cause your urine color to be red or orange for 1 or 2 days after you receive the injection. This is normal.
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 side effects
- 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 side effects
- pain at the injection site
- skin rash or itching
Rare side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 adverse events
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]
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References
1. (2001) "Product Information. Adriamycin PFS (doxorubicin)." Pharmacia and Upjohn
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. (2018) "Product Information. DOXOrubicin Liposomal (doxorubicin liposomal)." Caraco Pharmaceutical Laboratories
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Further information
Doxil side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.