Eloxatin Side Effects

Generic Name: oxaliplatin

Note: This page contains information about the side effects of oxaliplatin. Some of the dosage forms included on this document may not apply to the brand name Eloxatin.

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

For the Consumer

Applies to oxaliplatin: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by oxaliplatin (the active ingredient contained in Eloxatin). 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 oxaliplatin, check with your doctor or nurse immediately:

More common
  • Abnormal tongue sensation
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
  • blood in the urine or stools
  • burning, prickling, itching, or tingling of the skin
  • chest pain
  • chills
  • confusion
  • cough
  • decreased feeling, or pain in the hands, feet, around the mouth, or throat
  • decreased urination
  • difficulty performing daily activities such as writing, buttoning, swallowing, or walking
  • difficulty with articulating words
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • eye pain
  • fainting
  • fever
  • increase in heart rate
  • jaw spasm
  • lightheadedness
  • muscle pain or stiffness
  • numbness
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • pain in the chest, groin, or legs, especially the calves
  • pain in the joints
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid breathing
  • sensation of pins and needles
  • severe, sudden headache
  • shortness of breath
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • sunken eyes
  • swelling
  • swelling or inflammation of the mouth
  • swollen glands
  • thirst
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision changes
  • wrinkled skin
Less common
  • Convulsions
  • fast heartbeat
  • hives
  • increased thirst
  • irregular heartbeat
  • itching
  • loss of appetite
  • mood changes
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • tightness in the chest
  • wheezing
Incidence not known
  • Back, leg, or stomach pains
  • blindness
  • bloated abdomen
  • blue-yellow color blindness
  • blurred vision
  • changes in patterns and rhythms of speech
  • dark urine
  • deafness
  • decreased vision
  • deep breathing
  • drowsiness
  • electric shock-like sensation that moves down the back and into the legs following a bending movement of the neck
  • general body swelling
  • increased urination
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of deep tendon reflexes
  • muscle tremors
  • pain and fullness in the right upper abdomen
  • restlessness
  • severe constipation
  • severe diarrhea
  • severe nosebleeds
  • severe stomach cramps or tenderness
  • severe vomiting
  • trouble with speaking
  • twitches of the muscle visible under the skin
  • weakness of the muscles in your face
  • weight gain
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking oxaliplatin, get emergency help immediately:

Symptoms of overdose
  • Agitation
  • coma
  • cough or hoarseness
  • diarrhea
  • disorientation
  • involuntary, rapid, or rhythmic movement of the eyes
  • lack of coordination
  • lack of sensation
  • lethargy
  • lower back or side pain
  • paralysis
  • respiratory failure
  • seizures
  • severe weakness
  • slow or irregular heartbeat
  • tremors
  • vomiting, profuse

Some of the side effects that can occur with oxaliplatin 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
  • Acid or sour stomach
  • belching
  • body aches or pain
  • ear congestion
  • feeling unusually cold, shivering
  • headache
  • heartburn
  • indigestion
  • loss of voice
  • nasal congestion
  • runny nose
  • sleeplessness
  • sneezing
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unable to sleep
  • weight loss
Less common
  • Bad, unusual, or unpleasant (after) taste
  • bloated or full feeling
  • bloody nose
  • burning while urinating
  • change in taste
  • congestion
  • cracked lips
  • dryness or soreness of the throat
  • excess air or gas in stomach or intestines
  • feeling of warmth
  • hair loss
  • passing gas
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally upper chest
  • tender, swollen glands in the neck
  • thinning of the hair
  • unusual tearing of the eyes
  • voice changes

For Healthcare Professionals

Applies to oxaliplatin: intravenous powder for injection, intravenous solution

General

In general, side effects have been reported in 98% of patients, with 73% of those characterized as NCI CTC Grade 3/4 severity. The incidence of side effects given in the following sections refers to oxaliplatin (the active ingredient contained in Eloxatin) fluorouracil/leucovorin combination therapy.

The most common side effects include peripheral sensory neuropathies, neutropenia, nausea, emesis, and diarrhea. Thirteen percent of patients in the combination therapy group and 18% in the fluorouracil/leucovorin group discontinued treatment due to neuropathies, or gastrointestinal or hematologic side effects.

The incidence of death was 5% in the combination therapy group, 8% in the oxaliplatin monotherapy group, and 7% in the fluorouracil/leucovorin group within 30 days of treatment (regardless of causality).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (68% overall, 11% NCI CTC Grade 3/4), nausea (65% overall, 11% Grade 3/4), vomiting (40% overall, 9% Grade 3/4), stomatitis (37% overall, 3% Grade 3/4), abdominal pain (33% overall, 4% Grade 3/4), anorexia (29% overall, 3% Grade 3/4), and gastroesophageal reflux (5% overall, 2% Grade 3/4). Side effects with less than 1% incidence of Grade 3/4 severity have included constipation (32%), dyspepsia (14%), taste perversion (13%), mucositis (7%), and flatulence (5%). Additional side effects possibly related to treatment have been reported in 2% to 5% of patients and include dry mouth, melena, gingivitis, rectal hemorrhage, hemorrhoids, hemoptysis, proctitis, tenesmus, intestinal obstruction, and enlarged abdomen. Postmarketing gastrointestinal side effects have included ileus, pancreatitis, colitis (including Clostridium difficile diarrhea), severe diarrhea/vomiting resulting in hypokalemia, and intestinal obstruction.

Nervous system

Acute neuropathy is reversible and primarily of a peripheral sensory nature. The onset occurs within hours to 2 days of dosing. It generally resolves within 2 weeks and frequently recurs with repeat doses. Exposure to cold temperature or cold objects may precipitate or exacerbate symptoms. Symptoms may include transient paresthesia, dysesthesia, and hypoesthesia in the hands, feet, perioral area, or throat. Jaw spasm, abnormal tongue sensation, dysarthria, eye pain, and chest pressure have also been reported. Ice should be avoided for mucositis prophylaxis. Acute pharyngolaryngeal dysesthesia with sensations of dysphagia and dyspnea but no laryngospasm or bronchospasm has been reported in 1% to 2% of patients.

Persistent neuropathy generally lasts for more than 2 weeks and is also primarily of a peripheral sensory nature. Symptoms included paresthesias, dysesthesias, hypoesthesias, and deficits in proprioception that may interfere with daily activities (e.g., writing, buttoning, swallowing, or walking). Persistent neuropathy may occur with no prior neuropathy event. Eighty percent of patients who developed Grade 3 persistent neuropathy progressed from Grade 1 or 2. The symptoms may improve in some patients when oxaliplatin (the active ingredient contained in Eloxatin) is discontinued.

Preventive measures include calcium and magnesium solutions, gabapentin, carbamazepine, amifostine, and glutathione. Treatment measures include calcium and magnesium solutions, gabapentin, and alpha-lipoic acid.

Nervous system side effects which have been most frequently reported include two types of neuropathy (74%) - acute and persistent, with an incidence of 56% and 48%, respectively. Six percent of patients experienced NCI CTC Grade 3/4 persistent neuropathy.

Side effects with less than 1% incidence of Grade 3/4 severity have included headache, dizziness, and insomnia. Additional side effects possibly related to treatment have been reported in 2% to 5% of patients and include anxiety, depression, ataxia, nervousness, and somnolence. Postmarketing nervous system side effects include deafness, loss of deep tendon reflexes, dysarthria, Lhermitte sign, cranial nerve palsies, fasciculations, convulsions, and Reversible Posterior Leukoencephalopathy Syndrome (RPLS, also known as PRES).

Hematologic

Hematologic side effects have included thrombocytopenia (68% all grades; 4% NCI CTC Grade 3/4), neutropenia (73% all grades; 44% Grade 3/4), leukopenia (76% all grades; 19% Grade 3/4), anemia (81% all grades, 2% Grade 3/4), thromboembolism (9% overall, 8% Grade 3/4), and febrile neutropenia (6% overall, 6% Grade 3/4). Postmarketing hematologic side effects have included reports of immunoallergic thrombocytopenia, immunoallergic hemolytic anemia, hemolytic uremic syndrome, and prolongation of prothrombin time and of INR in patients receiving anticoagulants. One case of fatal hemolytic anemia has been reported.

Other

Side effects affecting the body as a whole have included fatigue (68% overall, 7% NCI CTC Grade 3/4), fever (29% overall, 1% Grade 3/4), back pain (19% overall, 3% Grade 3/4), edema (15% overall, 1% Grade 3/4), pain (15% overall, 2% Grade 3/4), chest pain (8% overall, 1% Grade 3/4), flushing (10%), peripheral edema (10%), rigors (10%), hot flashes (2% to 5%), and angioedema.

Respiratory

Respiratory side effects have included dyspnea (20% overall, 4% NCI CTC Grade 3/4) and coughing (19% overall, 1% Grade 3/4). Side effects with a less than 1% incidence of Grade 3/4 severity have included rhinitis (15%), upper respiratory tract infection (10%), pharyngitis (9%), epistaxis (9%), and hiccup (5%). Pulmonary fibrosis and other interstitial lung diseases (sometimes fatal) have also been reported (0.7%). A case of cryptogenic organizing pneumonitis has been reported.

Hypersensitivity

Patients who develop mild to moderate hypersensitivity to oxaliplatin (the active ingredient contained in Eloxatin) may be pretreated with steroids as well as type 1 and type 2 histamine receptor antagonists. However, patients who develop severe reactions are unlikely to tolerate further therapy.

Hypersensitivity reactions of an anaphylactoid and anaphylactic nature with symptoms of rash, urticaria, erythema, pruritus, and rarely, bronchospasm, and hypotension have been reported. Anaphylactic shock has also been reported. Less than 1% of hypersensitivity reactions were characterized as NCI CTC Grade 3/4. Other platinum compounds have been associated with fatal hypersensitivity reactions. Epinephrine, corticosteroids, and antihistamines have been used to manage symptoms. Postmarketing hypersensitivity reactions have included laryngospasm.

Hepatic

Hepatic side effects have included elevations in ALT (31% overall, 0% NCI CTC Grade 3/4), AST (47% overall, 0% Grade 3/4), and total bilirubin (13% overall, 1% Grade 3/4). Postmarketing hepatic side effects have included veno-occlusive disease of the liver (also known as sinusoidal obstruction syndrome) and perisinusoidal fibrosis (which rarely may progress).

Dermatologic

Dermatologic side effects with a less than 1% incidence of NCI CTC Grade 3/4 severity have included hand-foot syndrome (11%), rash (9%), and alopecia (7%). Erythematous rash and purpura have been reported in 2% to 5% of patients.

Local

Local side effects (injection site reactions) have been reported in 10% of patients (3%, NCI CTC Grade 3/4), including redness, swelling, and pain. Extravasation may result in severe pain and inflammation and cause complications such as necrosis.

Renal

Renal side effects have included serum creatinine elevations (10% overall, 1% NCI CTC Grade 3/4). Postmarketing renal side effects have included acute tubular necrosis, acute interstitial nephritis, and acute renal failure.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (10% overall, less than 1% Grade 3/4). Involuntary muscle contractions and muscle weakness have been reported in 2% to 5% of patients. Six cases of involuntary masticatory spasms induced by continuous infusion of oxaliplatin (the active ingredient contained in Eloxatin) have also been reported.

Metabolic

Metabolic side effects have included hypokalemia (9% overall, 4% NCI CTC Grade 3/4) and dehydration (8% overall, 3% Grade 3/4). Weight decrease (2% to 5%) and metabolic acidosis have also been reported.

Ocular

Ocular side effects have included abnormal lacrimation (7% overall, less than 1% NCI CTC Grade 3/4), conjunctivitis (2% to 5%), decrease of visual acuity, visual field disturbance, transient vision loss (reversible following therapy discontinuation), and optic neuritis. A case of acute bilateral abducens paralysis due to oxaliplatin (the active ingredient contained in Eloxatin) has also been reported.

Genitourinary

Genitourinary side effects that have been reported with a less than 1% incidence of NCI CTC Grade 3/4 severity include hematuria (6%) and dysuria (6%). Additional side effects possibly related to treatment have been reported in 2% to 5% of patients and include abnormal micturition frequency, vaginal hemorrhage, and urinary incontinence.

Cardiovascular

Cardiovascular side effects have included tachycardia (2% to 5%).

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