Applies to sirolimus protein-bound: intravenous powder for suspension.
Serious side effects
Along with its needed effects, sirolimus protein-bound 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 sirolimus protein-bound:
More common
- Bleeding gums
- blood in the urine or stools
- blurred vision
- chest pain
- chills
- confusion
- cough
- coughing up blood
- cracked lips
- decreased urine
- diarrhea
- difficulty in swallowing
- dizziness
- dry mouth
- fever
- flushed, dry skin
- fruit-like breath odor
- general feeling of discomfort or illness
- headache
- increased hunger
- increased menstrual flow or vaginal bleeding
- increased thirst
- increased urination
- irritation or soreness of the mouth
- lightheadedness
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- nosebleeds
- numbness or tingling in hands, feet, or lips
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- pounding in the ears
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- slow, fast, or irregular heartbeat
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach pain
- sunken eyes
- sweating
- swelling of the hands, ankles, feet, or lower legs
- thickening of bronchial secretions
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- wrinkled skin
Other side effects
Some side effects of sirolimus protein-bound 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
- Bleeding after defecation
- burning, numbness, tingling, or painful sensations
- constipation
- discoloration of the fingernails or toenails
- dry skin
- loss or thinning of the hair
- muscle or bone pain
- trouble sleeping
- uncomfortable swelling around the anus
- unsteadiness or awkwardness
- weakness in arms, hands, legs, or feet
For Healthcare Professionals
Applies to sirolimus protein-bound: intravenous powder for injection.
General
The most common adverse reactions were stomatitis (79%), fatigue and rash (68% each), infection (59%), nausea and edema (50% each), and diarrhea, musculoskeletal pain, and decreased weight (47% each).[Ref]
Cardiovascular
Very common (10% or more): Hypertension (29%)[Ref]
Dermatologic
Very common (10% or more): Rash (68%), alopecia (24%), pruritus (18%)
Dry skin (12%), nail disorder (12%)[Ref]
Gastrointestinal
Very common (10% or more): Stomatitis (79%), nausea (50%), diarrhea (47%), vomiting (32%), abdominal pain (29%), constipation (24%), dry mouth (15%), hemorrhoids (12%)[Ref]
Hematologic
Very common (10% or more): Hemorrhage (24%)[Ref]
Metabolic
Very common (10% or more): Decreased appetite (444%), dehydration (15%)[Ref]
Musculoskeletal
Very common (10% or more): Musculoskeletal pain - including arthralgias, back pain, myalgias (47%)[Ref]
Ocular
Very common (10% or more): Blurred vision (12%)[Ref]
Other
Very common (10% or more): Infections - upper respiratory tract infection, urinary tract infection, sinusitis, skin infection, folliculitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pneumonia, vaginal infection (59%)[Ref]
Psychiatric
Very common (10% or more): Insomnia (21%)[Ref]
Respiratory
Very common (10% or more): Cough (35%), pneumonitis (18%), dyspnea (12%)[Ref]
