Note: This document contains side effect information about paclitaxel. Some dosage forms listed on this page may not apply to the brand name Onxol.
Applies to paclitaxel: intravenous solution.
Warning
Intravenous route (Solution)
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in clinical trials. Fatal reactions have occurred in patients despite premedication, and all patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm(3) and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 cells/mm(3). Monitor peripheral blood cell counts frequently.
Serious side effects of Onxol
Along with its needed effects, paclitaxel (the active ingredient contained in Onxol) 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 paclitaxel:
More common
- Black or tarry stools
- blurred vision
- burning, numbness, tingling, or painful sensations
- confusion
- cough or hoarseness with fever or chills
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- fever or chills
- lower back or side pain
- painful or difficult urination
- pale skin
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- skin rash or itching
- sore throat
- sweating
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Less common
- Blood in the urine or stools
- difficult or labored breathing
- pinpoint red spots on the skin
- shortness of breath (severe)
- slow heartbeat
- tightness in the chest
- wheezing
Incidence not known
- Anxiety
- blue lips, fingernails, or skin
- difficult or troubled breathing
- fainting
- fast heartbeat
- irregular, fast or slow, or shallow breathing
- sudden shortness of breath
Other side effects of Onxol
Some side effects of paclitaxel 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, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- cracked lips
- diarrhea
- difficulty with swallowing
- hair loss
- nausea or vomiting
- numbness, burning, or tingling in the hands or feet
- pain in the joints or muscles, especially in the arms or legs
- thinning of the hair
For Healthcare Professionals
Applies to paclitaxel: intravenous solution.
Cardiovascular
Very common (10% or more): Hypotension
Common (1% to 10%): Bradycardia
Uncommon (0.1% to 1%): Cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, atrioventricular block and syncope, myocardial infarction, hypertension, thrombosis, thrombophlebitis
Rare (0.01% to 0.1%): Cardiac failure
Very rare (less than 0.01%): Atrial fibrillation, supraventricular tachycardia, shock
Frequency not reported: Phlebitis[Ref]
Dermatologic
Very common (10% or more): Alopecia (90%), rash
Common (1% to 10%): Transient and mild nail and skin changes, discoloration of the nail bed
Rare (0.01% to 0.1%): Pruritus, rash, erythema
Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), erythema multiforme, exfoliative dermatitis, urticaria, onycholysis (patients on therapy should wear sun protection on hands and feet), scleroderma-like reaction[Ref]
Gastrointestinal
Very common (10% or more): Nausea (52%), mucositis (31%), vomiting, diarrhea mucosal inflammation
Rare (less than 0.1%): Peritonitis, bowel obstruction, bowel perforation, ischemic colitis, pancreatitis
Very rare (less than 0.01%): Pseudomembranous colitis, mesenteric thrombosis, neutropenic colitis, esophagitis, constipation, ascites[Ref]
Hematologic
Very common (10% or more): Myelosuppression, neutropenia (90%), anemia, thrombocytopenia, leucopenia, bleeding
Rare (less than 0.1%): Febrile neutropenia[Ref]
Hepatic
Very common (10% or more): Elevated alkaline phosphatase (22%), elevated AST (SGOT) (19%)
Common (1% to 10%): Elevated bilirubin
Very rare (less than 0.01%): Hepatic necrosis, hepatic encephalopathy (both with reported cases of fatal outcome)[Ref]
Hypersensitivity
Very common (10% or more): Minor hypersensitivity reactions (mainly flushing and rash)
Uncommon (0.1% to 1%): Significant hypersensitivity reactions requiring therapy (e.g., hypotension, angioneurotic edema, respiratory distress, generalized urticaria, chills, back pain, chest pain, tachycardia, abdominal pain, pain in extremity, diaphoresis, hypertension)
Rare (less than 0.1%): Anaphylactic reactions
Very rare (less than 0.01%): Anaphylactic shock[Ref]
Immunologic
Very common (10% or more): Infections (mainly urinary tract and upper respiratory tract infections), with reported cases of fatal outcome
Uncommon (0.1% to 1%): Septic shock
Rare (less than 0.1%): Sepsis, pseudomembranous colitis[Ref]
Local
Common (1% to 10%): Injection site reactions (including localized edema, pain, erythema, induration, on occasion extravasation can result in cellulitis, skin fibrosis and skin necrosis)
Rare (less than 0.1%): Phlebitis[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia/myalgia (44%)
Frequency not reported: Systemic lupus erythematosus, scleroderma[Ref]
Metabolic
Common (1% to 10%): Severe elevation in aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), severe elevation in alkaline phosphatase
Uncommon (0.1% to 1%): Severe elevation in bilirubin
Rare (0.01% to 0.1%): Dehydration, increased blood creatinine
Very rare (less than 0.01%): Anorexia
Frequency not reported: Tumor lysis syndrome[Ref]
Nervous system
Very common (10% or more): Neurotoxicity (mainly peripheral neuropathy)
Rare (0.01% to 0.1%): Motor neuropathy (with resultant minor distal weakness)
Very rare (less than 0.01%): Autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), optic nerve disturbance, grand mal seizures, convulsions, encephalopathy, dizziness, headache, ataxia[Ref]
Ocular
Very rare (less than 0.01%): Optic nerve and/or visual disturbances (scintillating scotomata), particularly in patients who have received higher doses than recommended
Frequency not reported: Macular edema, photopsia, vitreous floaters[Ref]
Oncologic
Very rare (less than 0.01%): Acute myeloid leukemia, myelodysplastic syndrome[Ref]
Other
Rare (0.01% to 0.1%): Asthenia, pyrexia, edema, malaise
Very rare (less than 0.01%): Ototoxicity, hearing loss, tinnitus, vertigo[Ref]
Psychiatric
Very rare (less than 0.01%): Confusional state[Ref]
Respiratory
Rare (0.01% to 0.1%): Pneumonia, dyspnea, pleural effusion, interstitial pneumonia, lung fibrosis, pulmonary embolism, respiratory failure
Frequency not reported: Bronchospasm
Very rare (less than 0.01%): Cough[Ref]