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Abraxane Side Effects

Generic Name: paclitaxel protein-bound

Note: This page contains information about the side effects of paclitaxel protein-bound. Some of the dosage forms included on this document may not apply to the brand name Abraxane.

In Summary

Common side effects of Abraxane include: infection, severe peripheral sensory neuropathy, bone marrow depression, neutropenia, alopecia, anemia, and peripheral sensory neuropathy. Other side effects include: hypersensitivity reaction. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to paclitaxel protein-bound: intravenous powder for suspension

In addition to its needed effects, some unwanted effects may be caused by paclitaxel protein-bound (the active ingredient contained in Abraxane). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking paclitaxel protein-bound, check with your doctor or nurse immediately:

More common:
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred or double vision
  • chest pain
  • chills
  • cough
  • fever
  • loss of taste
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • sneezing
  • sore mouth, tongue, or throat
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • unusual tiredness or weakness
Less common:
  • Anxiety
  • bleeding
  • blood in the urine or stools
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, slow, or irregular heartbeat or pulse
  • general feeling of discomfort or illness
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • pain in the chest, groin, or legs, especially the calves
  • pinpoint red spots on the skin
  • rapid, shallow breathing
  • sensation of pins and needles
  • severe, sudden headache
  • skin itching, rash, or redness
  • slurred or slow speech
  • stabbing pain
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arms or legs
  • sudden, unexplained shortness of breath
  • sweating
  • swelling of the face, throat, or tongue
  • thickening of bronchial secretions
  • trouble thinking or walking

Minor Side Effects

Some of the side effects that can occur with paclitaxel protein-bound may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Cracked lips
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • headache
  • lack or loss of strength
  • loss of hair
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • swelling
  • vomiting
Less common:
  • Bleeding, blistering, burning, coldness, discoloration of the skin, a 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
Rare
  • Nail changes

For Healthcare Professionals

Applies to paclitaxel protein-bound: intravenous powder for injection

Dermatologic

Very common (10% or more): Alopecia (90%), rash
Common (1% to 10%): Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discoloration, skin hyperpigmentation, onycholysis, nail changes
Uncommon (0.1% to 1%): Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalized rash, dermatitis, night sweats, maculopapular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face
Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 82%), anemia (up to 25%), leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression
Common (1% to 10%): Febrile neutropenia
Rare (less than 0.1%): Pancytopenia[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy, neuropathy, hypoesthesia, paresthesia
Common (1% to 10%): Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Uncommon (0.1% to 1%): Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor, abnormal gait[Ref]

Cardiovascular

Very common (10% or more): Abnormal ECG (60%) including abnormal ECG in patients with a normal baseline (35%)
Common (1% to 10%): Tachycardia, arrhythmia, supraventricular tachycardia, flushing, hot flushes, hypertension, lymphedema, peripheral edema, chest pain
Uncommon (0.1% to 1%): Hypotension, peripheral coldness, orthostatic hypotension, chest discomfort, increased blood pressure
Rare (less than 0.1%): Bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block, thrombosis[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia/myalgia (44%)
Common (1% to 10%): Pain in extremity, bone pain, back pain, muscle cramps, limb pain, rigors
Uncommon (0.1% to 1%): Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness[Ref]

Hepatic

Very common (10% or more): AST (SGOT) elevations (39%), alkaline phosphatase elevations (36%), gamma-glutamyl transpeptidase (GGT) elevations (14%) patients
Common (1% to 10%): Bilirubin elevations
Uncommon (0.1% to 1%): Hepatomegaly
Rare (less than 0.1%): Hepatic necrosis, hepatic encephalopathy[Ref]

Gastrointestinal

Very common (10% or more): Nausea (30%), diarrhea (26%), vomiting (18%), constipation, stomatitis
Common (1% to 10%): Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastroesophageal reflux disease, oral hypoesthesia, mucosal inflammation
Uncommon (0.1% to 1%): Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, esophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal hemorrhage
Rare (less than 0.1%): Intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, neutropenic enterocolitis[Ref]

Other

Very common (10% or more): Fatigue, asthenia, pyrexia
Common (1% to 10%): Vertigo, pain, edema, weakness, decreased performance status, malaise, lethargy, hyperpyrexia
Uncommon (0.1% to 1%): Ear pain, tinnitus[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, sinusitis, interstitial pneumonitis, dyspnea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhea
Uncommon (0.1% to 1%): Nasopharyngitis, pneumonia, productive cough, exertional dyspnea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity (up to 12%)
Rare (less than 0.1%): Severe hypersensitivity[Ref]

Local

Uncommon (0.1% to 1%): Swelling, injection site reaction
Rare (0.01% to 0.1%): Extravasation[Ref]

Ocular

Common (1% to 10%): Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis
Uncommon (0.1% to 1%): Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus, keratitis
Rare (less than 0.1%): Cystoid macular edema[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, pollakiuria, hematuria, nocturia, polyuria, urinary incontinence, breast pain[Ref]

Metabolic

Very common (10% or more): Anorexia
Common (1% to 10%): Dehydration, hypokalemia, weight loss, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyltransferase, decreased hematocrit, decreased red blood cell count, increased blood alkaline phosphatase
Uncommon (0.1% to 1%): Hypophosphatasemia, fluid retention, hypoalbuminemia, polydipsia, hyperglycemia, hypocalcemia, hypoglycemia, hyponatremia, weight gain, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium, increased bilirubin[Ref]

Oncologic

Uncommon (0.1% to 1%): Metastatic pain, tumor necrosis[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression, anxiety
Uncommon (0.1% to 1%): Restlessness[Ref]

Immunologic

Very common (10% or more): Infections (up to 24%)
Common (1% to 10%): Febrile neutropenia, folliculitis, candidiasis, influenza-like illness
Uncommon (0.1% to 1%): Neutropenic sepsis, oral candidiasis, cellulitis, herpes simplex, viral infection, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis, neutropenic sepsis[Ref]

References

1. "Product Information. Abraxane (paclitaxel protein-bound)." American Pharmaceutical Partners, Schaumberg, IL.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Not all side effects for Abraxane may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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