Gleostine

Name: Gleostine

Gleostine Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • jaundice (yellowing of the skin or eyes);
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • signs of infection--fever, chills, sore throat, blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • kidney problems--confusion, little or no urinating; swelling in your feet or ankles; feeling tired or short of breath; or
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Late-onset lung damage has occurred in some adults who had been treated for brain tumors during childhood. These patients had been treated with both radiation and medicine similar to lomustine. Lung symptoms developed up to 17 years after treatment. Call your doctor at once if you have:

  • chest discomfort, dry cough or hack;
  • shortness of breath on exertion; or
  • weakness or tired feeling, loss of appetite, and rapid weight loss.

Common side effects may include:

  • nausea, vomiting;
  • delayed infection;
  • mouth sores; or
  • temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Chest pain.
  • Feeling confused.
  • Feeling very tired or weak.
  • Change in balance.
  • Trouble speaking.
  • Mouth irritation or mouth sores.
  • Change in eyesight.
  • Loss of eyesight.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Overdosage

Overdosage with Gleostine has occurred, including fatal cases [see Dosage and Administration ( 2.1), Warnings and Precautions ( 5.2)]. Overdosage causes severe myelosuppression, as well as abdominal pain, diarrhea, vomiting, anorexia, lethargy, dizziness, abnormal hepatic function, cough, and shortness of breath.

No antidotes exist for Gleostine overdosage.

For the Consumer

Applies to lomustine: oral capsule

Along with their needed effects, medicines like lomustine (the active ingredient contained in Gleostine) can sometimes cause unwanted effects such as blood problems, loss of hair, and other side effects; these are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Along with its needed effects, lomustine 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 immediately if any of the following side effects occur while taking lomustine:

More common
  • Bleeding gums
  • chest pain
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Awkwardness
  • black, tarry stools
  • blood in the urine or stools
  • confusion
  • cough or hoarseness
  • decrease in urination
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • slurred speech
  • swelling of the feet or lower legs
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain or tenderness
  • bone pain
  • change in frequency of urination or amount of urine
  • clay colored stools
  • dark urine
  • decreased appetite
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • increased blood pressure
  • increased thirst
  • itching
  • loss of appetite
  • nausea or vomiting
  • skin rash
  • weight gain
  • yellow eyes or skin

Some side effects of lomustine 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:

Less common
  • Darkening of the skin
  • diarrhea
Incidence not known
  • Blurred vision
  • changes in patterns and rhythms of speech
  • confusion about identity, place, and time
  • decreased vision
  • eye pain
  • hair loss or thinning of the hair
  • shakiness and unsteady walk
  • swelling or inflammation of the mouth
  • trouble with speaking
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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