Summary

Commonly reported side effects of oxaliplatin include: peripheral neuropathy and severe peripheral neuropathy. Continue reading for a comprehensive list of adverse effects.

Applies to oxaliplatin: parenteral concentrate for injection, parenteral powder for injection.

Side effects include:

Adjuvant combination therapy with fluorouracil and leucovorin in patients with colon cancer: Peripheral sensory neuropathy, nausea, vomiting, diarrhea, fatigue, anorexia, pyrexia, neutropenia, thrombocytopenia, anemia, elevated aminotransferase concentrations, elevated alkaline phosphatase concentrations.

Combination therapy with fluorouracil and leucovorin in patients with previously untreated advanced colorectal cancer: Adverse neurologic effects (i.e., neuropathy, including paresthesia, pharyngo-laryngeal dysesthesias), adverse GI effects (i.e., nausea, diarrhea, vomiting, stomatitis, anorexia, constipation, abdominal pain), fatigue, cough, alopecia, leukopenia, neutropenia, thrombocytopenia, anemia.

Combination therapy with fluorouracil and leucovorin in patients with previously treated advanced colorectal cancer: Adverse neurologic effects (i.e., neuropathy, including acute or persistent neuropathy), adverse GI effects (nausea, vomiting, diarrhea, stomatitis, abdominal pain, anorexia), fatigue, pyrexia, dyspnea, constipation, anemia, leukopenia, neutropenia, thrombocytopenia, elevated aminotransferase concentrations.

For Healthcare Professionals

Applies to oxaliplatin: intravenous powder for injection, intravenous solution.

Nervous system

Very common (10% or more): Peripheral sensory neuropathy/paresthesia (92%), pharyngo-laryngeal dysesthesia (38.2%), headache (17%), taste perversion (14%), dizziness (13%), neurosensory reactions (12%), dysgeusia, rigors/tremors

Common (1% to 10%): Sensory disturbance, neuralgia, neuro NOS (not otherwise specified), vertigo, syncope, ataxia, somnolence, intracerebral bleeding, abnormal tongue sensation

Rare (less than 0.1%): Dysarthria/aphasia, RPLS/PRES

Frequency not reported: Vocal cord paralysis, aphonia/dysphonia/hoarseness, trigeminal neuralgia/facial pain, myoclonus, abnormal coordination/abnormal gait, ataxia/balance disorders

Postmarketing reports: Loss of deep tendon reflexes, Lhermitte's sign, cranial nerve palsies, fasciculations, convulsion^[Ref]

Hematologic

Very common (10% or more): Anemia (85.2%), leukopenia (85%), neutropenia (82.2%), granulocytopenia (78.9%), thrombocytopenia (77.4%), fever without neutropenia (33%), infection - normal ANC (10%)

Common (1% to 10%): Leukopenia, infection - low ANC, lymphopenia, febrile neutropenia, immune-allergic thrombocytopenia prolongation of prothrombin time and INR, neutropenic sepsis

Rare (less than 0.1%): Autoimmune hemolytic anemia

Postmarketing reports: Hemolytic uremic syndrome^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (74%), diarrhea (67%), vomiting (54.1%), stomatitis/mucositis (44%), abdominal pain (33%), constipation (32%), anorexia (29%), dyspepsia (14%), diarrhea - colostomy (13%)

Common (1% to 10%): Gastrointestinal NOS (not otherwise specified), flatulence, dry mouth, rectal bleeding, rectal pain, rectal hemorrhage, gastrointestinal reflux, ascites, hemorrhoids, melena, proctitis, intestinal obstruction, gingivitis, tenesmus, enlarged abdomen, vaginal hemorrhage

Frequency not reported: Gastrointestinal bleeding

Postmarketing reports: Colitis, Clostridium difficile diarrhea, ileus, pancreatitis^[Ref]

Other

Very common (10% or more): Fatigue (70.3%), infection (31.6%), fever (29%), asthenia (23.4%), edema (15%), pain (15%), peripheral edema (10%)

Common (1% to 10%): Death, catheter infection, chest pain, unknown infection, feeling of chest pressure

Uncommon (0.1% to 1%): Ototoxicity

Postmarketing reports: Deafness, septic shock^[Ref]

Dermatologic

Very common (10% or more): Alopecia (67%), skin disorder (35.5%), sweating (12%), hand-foot syndrome (11%), rash (11%)

Common (1% to 10%): Pruritus, dry skin, nail changes, pigmentation changes, urticaria, erythematous rash, purpura^[Ref]

Hepatic

Very common (10% or more): Increased transaminases (57%), abnormal alkaline phosphatase (56.5%), abnormal AST (54%), abnormal ALT (36%), bilirubinemia (20%)

Postmarketing reports: Liver veno-occlusive disease/sinusoidal obstruction syndrome, perisinusoidal fibrosis^[Ref]

Respiratory

Very common (10% or more): Cough (35%), dyspnea (20%), epistaxis (16%), rhinitis (15%), allergic rhinitis (10%), upper respiratory tract infection (10%)

Common (1% to 10%): Hiccups, pneumonitis, other pulmonary reaction, hypoxia, pharyngitis, hemoptysis, pneumonia, bronchospasm

Rare (less than 0.1%): Acute interstitial lung disease, pulmonary fibrosis

Frequency not reported: Throat tightness/pressure/discomfort/pain

Postmarketing reports: Laryngospasm, other interstitial lung diseases^[Ref]

Metabolic

Very common (10% or more): Anorexia (35%), hyperglycemia (14%), hypokalemia (11%), decreased weight (11%), increased weight (10%)

Common (1% to 10%): Dehydration, hypoalbuminemia, hyponatremia, hypocalcemia, elevated creatinine, other metabolic reactions

Postmarketing reports: Metabolic acidosis^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (19%), myalgia (14%), arthralgia (10%)

Common (1% to 10%): Bone pain, muscle weakness, involuntary muscle contractions, jaw spasm/muscle spasm/muscle contractions

Frequency not reported: Muscle twitching

Postmarketing reports: Rhabdomyolysis^[Ref]

Psychiatric

Very common (10% or more): Insomnia (13%)

Common (1% to 10%): Depression, anxiety, nervousness^[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity reaction (12%), allergic reaction (10.3%)

Postmarketing reports: Angioedema, anaphylactic shock^[Ref]

Local

Very common (10% or more): Injection site reaction (11.1%)

Frequency not reported: Extravasation^[Ref]

Cardiovascular

Very common (10% or more): Flushing (10%)

Common (1% to 10%): Thrombosis/phlebitis, thromboembolism, hypotension, hypertension, tachycardia, hot flashes

Postmarketing reports: QT prolongation, ventricular arrhythmias, Torsade de Pointes^[Ref]

Genitourinary

Common (1% to 10%): Abnormal micturition frequency, dysuria, hematuria, urinary incontinence^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, abnormal lacrimation, abnormal vision, tearing

Rare (less than 0.1%): Optic neuritis

Frequency not reported: Ptosis, diplopia, eye pain

Postmarketing reports: Decreased visual acuity, visual field disturbance/disorders, transient/reversible vision loss^[Ref]

Oncologic

Common (1% to 10%): Secondary malignancies^[Ref]

Renal

Common (1% to 10%): Altered renal function

Very rare (less than 0.01%): Renal tubular necrosis

Postmarketing reports: Acute interstitial nephritis, acute renal failure^[Ref]