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Generic Name: dactinomycin (DAK tin oh MYE sin)
Brand Name: Cosmegen
Physician reviewed Cosmegen patient information - includes Cosmegen description, dosage and directions.
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Drug Information:
Cosmegen is used to treat different types of cancers that affect the kidneys, uterus, testicles, bones, muscles, joints, and soft tissues. This medicine is also used to treat solid tumors. Cosmegen may also be used for purposes not listed in this medication guide. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Using Cosmegen may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk. Learn more

Cosmegen Side Effects

Cosmegen Side Effects

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

For the Consumer

Applies to dactinomycin: intravenous powder for solution

Along with its needed effects, dactinomycin (the active ingredient contained in Cosmegen) 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:

More common

  • Black, tarry stools
  • blood in the urine or stools
  • chills
  • cough
  • diarrhea (continuing)
  • difficulty with swallowing
  • fever
  • heartburn
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • sores in the mouth and on the lips
  • stomach pain (continuing)
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • body aches or pain
  • chapped, red, or swollen lips
  • confusion
  • congestion
  • cough
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dryness or soreness of the throat
  • flushing or redness of the skin
  • irregular heartbeat
  • joint pain or swelling
  • muscle ache, pains, or stiffness
  • muscle cramps in the hands, arms, feet, legs, or face
  • numbness and tingling around the mouth, fingertips, or feet
  • pain at the injection site
  • runny nose
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • seizures
  • slow growth
  • stomach cramps
  • swelling of the feet or lower legs
  • tender, swollen glands in the neck
  • tremor
  • unusually warm skin
  • voice changes
  • yellow eyes or skin

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:

More common

  • Darkening of the skin
  • general feeling of discomfort or weakness
  • nausea
  • skin rash or acne
  • unusual feeling of dullness or sluggishness
  • vomiting

For Healthcare Professionals

Applies to dactinomycin: intravenous powder for injection


Frequency not reported: Proctitis, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, nausea, vomiting, abdominal pain, diarrhea, GI ulceration, nausea, vomiting


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


Frequency not reported: Anemia, aplastic anemia, agranulocytosis, leukopenia, neutropenia, febrile neutropenia, thrombocytopenia, pancytopenia, reticulocytopenia, disseminated intravascular coagulation


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)


Very rare (less than 0.01%): Contracture of the arms

Frequency not reported: Extravasation, severe damage to soft tissue, epidermolysis, erythema, edema


Frequency not reported: Hypocalcemia, anorexia, hypocalcemia, tumor lysis syndrome (TLS)


Frequency not reported: Myalgia, growth retardation


Frequency not reported: Hypersensitivity


Postmarketing reports: Thrombophlebitis, hemorrhage


Frequency not reported: Secondary malignancy (e.g., leukemia)


Frequency not reported: Sepsis (e.g., neutropenic sepsis), infection


Frequency not reported: Optic neuropathy


Frequency not reported: Pharyngitis, pneumonitis

Postmarketing reports: Pneumothorax


Frequency not reported: Malaise, fatigue, lethargy, fever, radiation toxicity, radiation recall

Nervous system

Frequency not reported: Peripheral neuropathy


Frequency not reported: Renal toxicity

Postmarketing reports: Renal failure

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Cosmegen