Cosmegen Side Effects

Generic name: dactinomycin

Medically reviewed by Drugs.com. Last updated on Jan 18, 2025.

Note: This document provides detailed information about Cosmegen.

Applies to dactinomycin: intravenous powder for solution Side Effects associated with dactinomycin. Some dosage forms listed on this page may not apply specifically to the brand name Cosmegen.

Applies to dactinomycin: intravenous powder for solution.

Precautions

It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may increase your risk of having other cancer (including leukemia). Talk with your doctor if you have concerns about this.

While you are being treated with dactinomycin (the active ingredient contained in Cosmegen) and after you stop treatment with it, do not have any live vaccines without your doctor's approval. Dactinomycin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Dactinomycin 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 could occur.

Check with your doctor right away if you have diarrhea, nausea or vomiting, or sores or white patches on your lips, mouth, or throat while receiving this medicine.

If dactinomycin accidentally seeps out of the vein into which it is injected, it may severely damage some tissues and cause scarring. Tell your doctor right away if you notice redness, pain, or swelling at the injection site.

Serious side effects of Cosmegen

Along with its needed effects, dactinomycin 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 dactinomycin:

Other side effects of Cosmegen

Some side effects of dactinomycin 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:

For healthcare professionals

Applies to dactinomycin: intravenous powder for injection.

Gastrointestinal adverse events

• Frequency not reported: Proctitis, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, nausea, vomiting, abdominal pain, diarrhea, GI ulceration, nausea, vomiting^[Ref]

Hepatic

• Frequency not reported: Liver function test abnormalities, ascites, hepatomegaly, hepatitis, hepatic failure, hepatic veno-occlusive disease (VOD)^[Ref]

Hematologic

• Frequency not reported: Anemia, aplastic anemia, agranulocytosis, leukopenia, neutropenia, febrile neutropenia, thrombocytopenia, pancytopenia, reticulocytopenia, disseminated intravascular coagulation^[Ref]

Dermatologic

• Frequency not reported: Alopecia, skin eruptions, acne, erythema multiforme, flare-up of erythema, increased pigmentation of previously irradiated skin
• Postmarketing reports: Toxic epidermal necrolysis (TEN), Stevens Johnson Syndrome (SJS)^[Ref]

Local

• Very rare (less than 0.01%): Contracture of the arms
• Frequency not reported: Extravasation, severe damage to soft tissue, epidermolysis, erythema, edema^[Ref]

Metabolic

• Frequency not reported: Hypocalcemia, anorexia, hypocalcemia, tumor lysis syndrome (TLS)^[Ref]

Musculoskeletal

• Frequency not reported: Myalgia, growth retardation^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity^[Ref]

Cardiovascular

• Postmarketing reports: Thrombophlebitis, hemorrhage^[Ref]

Oncologic

• Frequency not reported: Secondary malignancy (e.g., leukemia)^[Ref]

Immunologic

• Frequency not reported: Sepsis (e.g., neutropenic sepsis), infection^[Ref]

Ocular

• Frequency not reported: Optic neuropathy^[Ref]

Respiratory

• Frequency not reported: Pharyngitis, pneumonitis
• Postmarketing reports: Pneumothorax^[Ref]

Other

• Frequency not reported: Malaise, fatigue, lethargy, fever, radiation toxicity, radiation recall^[Ref]

Nervous system

• Frequency not reported: Peripheral neuropathy^[Ref]

Renal

• Frequency not reported: Renal toxicity
• Postmarketing reports: Renal failure^[Ref]

See also:

Further information

Cosmegen 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.

Medical Disclaimer