Myleran Side Effects
Generic name: busulfan
Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.
Note: This document provides detailed information about Myleran Side Effects associated with busulfan. Some dosage forms listed on this page may not apply specifically to the brand name Myleran.
Applies to busulfan: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Busulfan causes severe or prolonged myelosuppression at recommended doses.
Hematopoietic progenitor cell transplantation is required to prevent life-threatening or fatal complications of severe or prolonged myelosuppression.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine 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 to keep you or your sexual partner from getting pregnant during or after treatment. If you think you have become pregnant while using this medicine, tell your doctor right away.
Busulfan 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.
This medicine may cause hepatic veno-occlusive disease (HVOD). This usually occurs if you receive too much busulfan (the active ingredient contained in Myleran) or receive this medicine before radiation treatment, or have a prior progenitor cell transplant. Call your doctor right away if you have a bloated abdomen or stomach, upper right abdominal or stomach pain, weight gain, or yellow eyes or skin.
While you are being treated with busulfan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Busulfan 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.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some body tissue studies may be affected by this medicine.
Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Myleran
Along with its needed effects, busulfan 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 busulfan:
More common side effects
- black, tarry stools
- bloated abdomen or stomach
- blood in the urine or stools
- blurred vision
- chest pain
- cough or hoarseness
- dizziness
- fast or irregular breathing
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- headache
- lower back or side pain
- nervousness
- pain and fullness in the upper abdominal or stomach
- painful or difficult urination
- pinpoint red spots on the skin
- pounding in the ears
- skin rash or itching
- slow heartbeat
- swelling of the eyes or eyelids
- tightness in the chest
- trouble breathing
- unusual bleeding or bruising
- weight gain
- yellow eyes and skin
Incidence not known
- seizures
Other side effects of Myleran
Some side effects of busulfan 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
- acid or sour stomach
- back pain
- belching
- bloody nose
- depression
- diarrhea
- difficulty having a bowel movement (stool)
- fear
- heartburn
- indigestion
- loss of appetite
- lack or loss of strength
- sneezing
- stomach discomfort or upset
- stuffy nose or runny nose
- swelling or inflammation of the mouth
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
- trouble sleeping
For healthcare professionals
Applies to busulfan: intravenous solution, oral tablet.
Hematologic adverse events
- Very common (10% or more): Prolonged myelosuppression (i.e., severe granulocytopenia, leukopenia, thrombocytopenia, anemia, or any combination thereof) (100%)
- Rare (less than 0.1%): Aplastic anemia
- Frequency not reported: Prolonged prothrombin time
- Postmarketing reports: Febrile neutropenia[Ref]
Respiratory
- Very common (10% or more): Rhinitis (44%), lung disorder (34%), cough (28%), epistaxis (25%), dyspnea (25%)
- Rare (less than 0.1%): Bronchopulmonary dysplasia
- Frequency not reported: Pneumonia, hyperventilation, alveolar hemorrhage, pharyngitis, hiccup, asthma, atelectasis, pleural effusion, hypoxia, hemoptysis, sinusitis, interstitial fibrosis[Ref]
Cardiovascular
- Very common (10% or more): Tachycardia (44%), hypertension (36%), chest pain (26%), vasodilation (25%)
- Common (1% to 10%): Cardiac tamponade in patients with thalassemia (at high doses)
- Frequency not reported: Arrhythmia, atrial fibrillation, ventricular extrasystoles, third degree heart block, thrombosis (all episodes were associated with the central venous catheter), hypotension, flushing and hot flashes, cardiomegaly, ECG abnormality, left-sided heart failure, pericardial effusion, cardiac tamponade
- Postmarketing reports: Thrombotic microangiopathy (TMA)[Ref]
Ocular
- Rare (less than 0.1%): Lens disorder and cataract (which may be bilateral), corneal thinning (reported after bone marrow transplantation preceded by high-dose therapy)[Ref]
Dermatologic
- Very common (10% or more): Rash (57%), pruritus (28%)
- Common (1% to 10%): Alopecia[Ref]
Metabolic
- Very common (10% or more): Hypomagnesemia (77%), hyperglycemia (66%), hypokalemia (64%), hypocalcemia (49%), hyperbilirubinemia (49%), edema (36%), serum glutamic pyruvic transaminase (SGPT) elevation (31%), creatinine increased (21%)
- Frequency not reported: Hypervolemia, hypophosphatemia, hyponatremia[Ref]
Hepatic
- Very common (10% or more): SGPT Elevation
- Common (1% to 10%): Hepatic veno-occlusive disease (HVOD)
- Rare (less than 0.1%): Jaundice, abnormal hepatic function, biliary fibrosis
- Frequency not reported: Alkaline phosphatase increase, jaundice, hepatomegaly[Ref]
Nervous system
- Very common (10% or more): Headache (69%), asthenia (51%), dizziness (30%)
- Common (1% to 10%): Seizures
- Very rare (less than 0.01%): Myasthenia gravis
- Frequency not reported: Cerebral hemorrhage, coma, delirium, agitation, encephalopathy, confusion, hallucinations, lethargy, somnolence[Ref]
Oncologic
- Common (1% to 10%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)
- Postmarketing reports: Tumor lysis syndrome, cellular dysplasia[Ref]
Genitourinary
- Very rare (less than 0.01%): Gynecomastia
- Frequency not reported: Dysuria, oliguria, hematuria, hemorrhagic cystitis[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (98%), stomatitis (mucositis) (97%), vomiting (95%), anorexia (85%), diarrhea (84%), abdominal pain (72%), dyspepsia (44%), dry mouth (26%), rectal disorder (25%), abdominal enlargement (23%)
- Frequency not reported: Esophagitis, ileus, hematemesis, pancreatitis, rectal discomfort
- Postmarketing reports: Tooth hypoplasia[Ref]
Musculoskeletal
- Very common (10% or more): Chills (46%), back pain (23%)
- Frequency not reported: Myalgia, arthralgia[Ref]
Immunologic
- Frequency not reported: Graft-versus-host disease
- Postmarketing reports: Severe bacterial, viral (e.g., cytomegalovirus viremia), fungal infections, sepsis[Ref]
Hypersensitivity
- Very common (10% or more): Allergic reaction (26%)[Ref]
Local
- Very common (10% or more): Injection site inflammation (25%)
- Frequency not reported: Injection site pain[Ref]
Renal
- Frequency not reported: Blood urea nitrogen (BUN) increased[Ref]
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References
1. (2001) "Product Information. Myleran (busulfan)." Prasco Laboratories
2. (2004) "Product Information. Busulfex (busulfan)." ESP Pharma Inc
3. (2018) "Product Information. Busulfan (busulfan)." Amneal Pharmaceuticals
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Further information
Myleran 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.