Bone marrow suppression is the most frequent significant undesirable effect of paclitaxel use. Other severe reactions associated with the use of paclitaxel are peripheral neuropathy, arthralgia, myalgia, hypersensitivity reaction (with possible fatal outcome), and injection site reactions.
The frequency and severity of hematologic toxicity increase with dose, especially at paclitaxel doses exceeding 190 mg/m2
. Dose- and schedule-dependent paclitaxel-induced neutropenia is generally rapidly reversible. The onset of neutropenia usually occurs 8 to 10 days and neutrophil nadirs generally occur at a median of 10 to 12 days after paclitaxel administration. Neutrophil counts commonly recover 15 to 21 days after administration.
The following adverse reactions have also been reported with paclitaxel use: Infections and Infestations:
Infection (mainly urinary tract and upper respiratory tract infections), with reported cases of fatal outcome, septic shock, pneumonia, peritonitis, sepsis, pseudomembranous colitis.
Neoplasms benign, malignant and unspecified (including cysts and polyps):
Acute myeloid leukemia, myelodysplastic syndrome, tumour lysis syndrome.
Blood and lymphatic system disorders:
Myelosuppression, neutropenia, anemia, thrombocytopenia, leukopenia, eosinophilia, bleeding, febrile neutropenia, neutropenic enterocolitis.
Immune system disorders:
Minor hypersensitivity reactions (mainly flushing and rash), significant hypersensitivity reactions requiring therapy (e.g., hypotension, angioneurotic edema, respiratory distress, generalised urticaria, chills, back pain, chest pain, tachycardia, abdominal pain, pain in extremity, diaphoresis, and hypertension), anaphylactic reactions, anaphylactic shock, Stevens-Johnson Syndrome, erythema multiforme, exfoliative dermatitis, scleroderma.
Metabolism and nutrition disorders:
Anorexia, respiratory failure, dehydration, edema.
Nervous system disorders:
Neurotoxicity (mainly peripheral neuropathy), motor neuropathy (with resultant minor distal weakness), autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), grand mal seizures, convulsions, encephalopathy, dizziness, headache, paresthesia, hypoesthesia, perioral numbness, hyperesthesia, acute and temporary worsening of Parkinsonian Syndrome, stroke, hepatic coma, photopsia, hepatic encephalopathy (both with reported cases of fatal outcome).
Optic nerve and/or visual disturbances (scintillating scotomata) particularly in patients who have received higher doses than recommended, macular edema, vitreous floaters, keratitis, conjunctivitis, increased lacrimation.
Ear and labyrinth disorders:
hearing loss, tinnitus, vertigo.
Bradycardia, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, atrio-ventricular block and syncope, myocardial infarction, cardiac failure, atrial fibrillation, supraventricular tachycardia, arrhythmia, acute pulmonary edema, cardiac arrest, congestive heart failure.
Hypotension, hypertension, thrombosis, thrombophlebitis, shock, hemorrhage, embolism, transient ischemic attack, ischemic colitis.
Respiratory, thoracic and mediastinal disorders:
Pleural effusion, interstitial pneumonia, lung fibrosis, pulmonary embolism, cough, dyspnea, radiation pneumonitis, transient pulmonary infiltration.
Nausea, vomiting, diarrhea, bowel perforation, pancreatitis, mesenteric thrombosis, esophagitis, constipation, oral candidiasis, intestinal obstruction, dysphagia.
Hepatic necrosis, ascites.
Skin and subcutaneous tissue disorders:
Alopecia, transient and mild nail and skin changes, pruritus, rash, erythema, onycholysis (patients on therapy should wear sun protection on hands and feet), skin exfoliation, acral erythema, generalized pustular dermatosis, dermatitis bullous.
Musculoskeletal and connective tissue disorders:
Arthralgia, myalgia, systemic lupus erythematosus.
Renal and urinary disorders:
Acute renal failure, renal toxicity.
General disorders and administration site conditions:
Asthenia, pyrexia, malaise, mucositis, induration, fatigue, lethargy, ataxia, mucosal inflammation.
Severe elevation in aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), severe elevation in alkaline phosphatase, severe elevation in bilirubin, increase in blood creatinine, abnormal electrocardiogram.
Injury, poisoning and procedural complications:
Phlebitis, radiation recall reaction, ototoxicity, epidermal necrolysis, injection site reactions (including localized edema, pain, erythema, induration, on occasion extravasation can result in cellulitis, skin fibrosis and skin necrosis).