Applies to dactinomycin: intravenous powder for solution.
Serious side effects of Dactinomycin
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:
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
Other side effects of Dactinomycin
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.
Gastrointestinal
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]
