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Cosmegen Side Effects

Generic Name: dactinomycin

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

For the Consumer

Applies to dactinomycin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by dactinomycin (the active ingredient contained in Cosmegen). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking dactinomycin, check with your doctor or nurse immediately:

More common:
  • Black, tarry stools
  • blood in the urine or stools
  • cough or hoarseness accompanied by fever or chills
  • diarrhea (continuing)
  • difficulty with swallowing
  • fever or chills
  • heartburn
  • lower back or side pain accompanied by fever or chills
  • painful or difficult urination accompanied by fever or chills
  • 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
  • Joint pain
  • pain at the injection site
  • swelling of the feet or lower legs
  • wheezing
  • yellow eyes or skin
Incidence not known:
  • Abdominal or stomach cramps
  • blisters
  • body aches or pain
  • chapped, red, or swollen lips
  • confusion
  • congestion
  • convulsions
  • cough
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dryness or soreness of the throat
  • flushing or redness of the skin
  • growth retardation
  • irregular heartbeats
  • muscle aching or cramping
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle pains or stiffness
  • numbness and tingling around the mouth, fingertips, or feet
  • runny nose
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • shortness of breath
  • swollen joints
  • tender, swollen glands in the neck
  • tremor
  • unusually warm skin
  • voice changes

Minor Side Effects

Some of the side effects that can occur with dactinomycin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

For Healthcare Professionals

Applies to dactinomycin: intravenous powder for injection


Gastrointestinal side effects have been reported in 75% of patients and are usually mild to moderate in severity. Nausea and vomiting may present within hours of administration, may be dose-limiting, may be most intense two to four days after the end of a five-day course, typically require and respond to antiemetic therapy, and may persist for as long as a week after therapy is stopped. Intravenously administered ondansetron is compatible with dactinomycin (the active ingredient contained in Cosmegen) for up to four hours. Other serious gastrointestinal problems include cheilitis (inflammation of the lip), dysphagia, esophagitis, ulcerative stomatitis, and pharyngitis. Anorexia, abdominal pain, diarrhea, proctitis and gastrointestinal ulceration have also been reported.[Ref]

Radiation-recall enteritis has been reported after the use of dactinomycin and doxorubicin therapy.[Ref]


Hepatic side effects have been serious, ranging from elevated liver function tests in approximately 17% of patients to rare cases of hepatitis, hepatomegaly, ascites, hepatic failure, hepatic veno-occlusive disease which may be associated with intravascular clotting disorder and multi-organ failure, and death. Dactinomycin-induced hepatotoxicity may be more likely in the presence of x-radiation therapy to an hepatic port (not uncommon during treatment of right-sided Wilms' tumors) or after higher single doses. There appears to be a causal relationship between dactinomycin (the active ingredient contained in Cosmegen) and the development of veno-occlusive disease of the liver.[Ref]

X-radiation therapy (XRT) to the liver apparently produces a vascular lesion affecting primarily the small hepatic veins leading to vascular obstruction and hyperemia. The contribution of dactinomycin towards the development of veno-occlusive disease of the liver is unknown. Some experts have suggested a two-month interval between XRT to the liver and dactinomycin therapy.

A rare case of portal hypertension that necessitated mesocaval shunting because of life-threatening esophageal variceal hemorrhaging has been associated with the use of dactinomycin and x-radiation therapy in a girl who had been treated for a right-sided Wilms' tumor.[Ref]


Myelosuppression can be dose-limiting or life-threatening.

Experts recommend DAILY complete blood cell counts to detect severe hematopoietic depression and withholding therapy if any cell line becomes markedly depressed. Bone marrow recovery typically takes three weeks.

Elderly patients may be associated with an increased risk of myelosuppression compared to younger patients.[Ref]

Hematologic side effects have presented as myelosuppression in approximately 20% to 50% of patients. Leukopenia and thrombocytopenia have typically been observed at one to two weeks after doses are started, but nadirs can be delayed until three weeks. Anemia, even aplastic anemia, agranulocytosis, pancytopenia, reticulopenia, neutropenia, febrile neutropenia,
and rare cases of immune thrombocytopenia have also been reported.[Ref]


Dermatologic side effects have been common, and included alopecia, skin eruptions (including bullous pemphigoid and folliculitis), acne, and exacerbations of erythema or increased pigmentation associated with previous disease or x-radiation therapy. Alopecia has typically developed within one to four weeks, and resolved within two to three months.[Ref]

Dactinomycin-induced RNA damage precludes growing cells (in vitro) from repairing sublethal radiation damage. The pathogenesis of "radiation recall" is otherwise poorly understood. Theories include primary cytologic damage to neurons, glia and myelin; an allergic reactive phenomenon; and damage to neural tissue secondary to vascular injury. Factors related to the intensity of "radiation recall" appear to include individual patient variation, the total dose of radiation administered, and the intensity of the radiation. Incidentally, patients who experience radiation recall are more likely to also experience gastrointestinal and bone marrow toxicity.

Some severe cases of acne associated with the use of dactinomycin have also been associated with elevated levels of androgenous serum hormones.[Ref]


Local side effects have included IV site extravasation which should be rigorously avoided as dactinomycin (the active ingredient contained in Cosmegen) is extremely toxic and corrosive. Extravascular infiltrates should be aspirated and treated locally with hydrocortisone and/or sodium thiosulfate. Extravasation has resulted in severe soft tissue damage, including necrosis and contracture of extremities.[Ref]


General side effects including malaise, fatigue, lethargy, muscle aches, and fever have been reported.[Ref]


Metabolic side effects have been associated with overdoses of dactinomycin (the active ingredient contained in Cosmegen) including hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia. Excessive urinary magnesium loss has been documented in such rare cases. Hypocalcemia may be observed after usual therapeutic doses.[Ref]


Musculoskeletal side effects have generally been limited to myalgias. The pediatric literature describes radiographic findings of transverse lines of long bones associated with the use of dactinomycin (the active ingredient contained in Cosmegen) [Ref]


Hypersensitivity side effects, including frank anaphylaxis reactions, have been reported, but have been rare.[Ref]


Endocrinologic side effects have been rare. Gynecomastia without elevated serum beta-HCG levels has been associated with dactinomycin (the active ingredient contained in Cosmegen) therapy in males with testicular cancer. Thymic enlargement has rarely been associated with the use of dactinomycin (with later generation computerized axial tomograms [CT scans] the thymus is demonstrable in all patients less than 30 years old).[Ref]


Cardiovascular side effects have been rare. A single case of portal hypertension has been reported. Rare cases of pericarditis have been associated with the use of dactinomycin (the active ingredient contained in Cosmegen) in combination with other antineoplastic agents, such as cyclophosphamide, vinblastine, bleomycin, and cisplatin.[Ref]


Oncologic side effects have consisted of animal data which have reported that dactinomycin (the active ingredient contained in Cosmegen) is a carcinogen. In vivo animal data have revealed sarcomas and mesenchymal tumors after regular subcutaneous or intraperitoneal injections. In vitro and in vivo human data have shown dactinomycin to be mutagenic in a number of test systems, including human fibroblasts, leukocytes and HELA cells.[Ref]


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Not all side effects for Cosmegen may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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