Tarceva Side Effects

Generic Name: erlotinib

Note: This page contains side effects data for the generic drug erlotinib. It is possible that some of the dosage forms included below may not apply to the brand name Tarceva.

It is possible that some side effects of Tarceva may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to erlotinib: oral tablet

As well as its needed effects, erlotinib (the active ingredient contained in Tarceva) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking erlotinib, check with your doctor immediately:

More common
  • Burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • cough or hoarseness
  • diarrhea (severe)
  • difficult or labored breathing
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • rash (severe)
  • sensation of pins and needles
  • stabbing chest pain
  • tightness in the chest
Rare
  • Bloody or black, tarry stools
  • blurred vision
  • chest pain or discomfort
  • constipation
  • convulsions (seizures)
  • eye irritation or redness
  • inability to speak
  • pain or discomfort in the arms, jaw, back, or neck
  • severe stomach pain
  • slurred speech
  • sudden, severe chest pain
  • sudden, severe headache
  • sudden, severe weakness in the arm or leg on one side of the body
  • sweating
  • vision changes
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Agitation
  • blistering, peeling, or loosening of the skin
  • bloody nose
  • burning feeling in the chest or stomach
  • burning upper abdominal or stomach pain
  • confusion
  • dark-colored urine
  • darkening of the skin
  • decreased urine output
  • general feeling of tiredness or weakness
  • headache
  • increased thirst
  • irregular heartbeat
  • lethargy
  • light-colored stools
  • loss of appetite
  • mood changes
  • muscle pain or stiffness
  • muscle twitching
  • nausea or vomiting
  • rapid weight gain
  • red skin lesions, often with a purple center
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain, continuing
  • stupor
  • swelling of the face, ankles, or hands
  • tenderness in the stomach area
  • trouble breathing
  • unusual tiredness or weakness
  • yellow eyes or skin

Some erlotinib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • blemishes on the skin
  • bloated or full feeling
  • bone pain
  • burning, dry, or itching eyes
  • diarrhea (mild)
  • difficulty with moving
  • dizziness
  • dry eyes
  • dry skin
  • excess air or gas in the stomach or intestines
  • excessive tearing
  • fear
  • feeling sad or empty
  • feeling unusually cold
  • hair loss
  • headache
  • heartburn
  • indigestion
  • irritability
  • itching skin
  • joint pain
  • loss of interest or pleasure
  • nervousness
  • passing gas
  • pimples
  • rash, mild
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • shivering
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swelling
  • swelling or inflammation of the mouth
  • swollen joints
  • thinning of the hair
  • tiredness
  • trouble or inability to sleep
  • trouble with concentrating
  • weight loss
Less common
  • Loosening of the fingernails
  • redness or soreness around the fingernails
Incidence not known
  • Brittle and loose nails
  • discharge, excessive tearing
  • increased hair growth, especially on the face

For Healthcare Professionals

Applies to erlotinib: oral tablet

Respiratory

Very common (10% or more): Dyspnea (41%), cough (Up to 33%)
Common (1% to 10%): Epistaxis, interstitial lung disease[Ref]

Dermatologic

Very common (10% or more): Rash (69 to 75%), alopecia (14%), pruritus (13%), dry skin (12%)
Common (1% to 10%): Acne, dermatitis acneiform, folliculitis, skin fissures, paronychia
Uncommon (0.1% to 1%): Hyperpigmentation, hirsutism, brittle/loose nails, eyebrow changes
Rare (less than 0.1%): Palmar plantar erythrodysesthesia syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (48 to 54%), nausea (33%), vomiting (23%), stomatitis (17 to 22%), dyspepsia (17%), flatulence (13%), abdominal pain (11%)
Common (1% to 10%): Gastrointestinal bleeding
Uncommon (0.1% to 1%): Gastrointestinal perforations[Ref]

Hepatic

Common (1% to 10%): Liver function test abnormalities (including elevated ALT, AST, bilirubin)
Rare (less than 0.1%): Hepatic failure and hepatorenal syndrome (including fatalities)[Ref]

These elevations were mostly transient or associated with liver metastases.

A pharmacokinetic study in patients with advanced solid tumors and moderate hepatic impairment according to the Child-Pugh criteria has been reported. In this study, 10 of the 15 patients died on treatment or within 30 days of the last dose. Eight of these patients died from progressive disease, one patient died from hepatorenal syndrome, and one patient died from rapidly progressing liver failure. Six out of the 10 patients who died had baseline total bilirubin greater than 3 times the upper limit of normal suggesting severe, rather than moderate, hepatic impairment. All patients had hepatic impairment due to advanced cancer with liver involvement such as hepatocellular carcinoma, cholangiocarcinoma, or liver metastases.[Ref]

General

The most common side effects included rash, diarrhea, anorexia, dyspnea, cough, fatigue, nausea, and vomiting.[Ref]

Immunologic

Very common (10% or more): Infection (24 to 31%)[Ref]

Ocular

Very common (10% or more): Conjunctivitis (12%), keratoconjunctivitis sicca (12%)
Common (1% to 10%): Keratitis
Uncommon (0.1% to 1%): Eyelash changes
Rare (less than 0.1%): Corneal ulcerations or perforations
Post-marketing surveillance: Uveitis[Ref]

Renal

Common (1% to 10%): Renal insufficiency
Uncommon (0.1% to 1%): Nephritis, proteinuria

Other

Very common (10% or more): Fatigue (Up to 73%), pyrexia (36%)[Ref]

Cardiovascular

Common (1% to 10%): Myocardial infarction/ischemia, cerebrovascular accident

Metabolic

Very common (10% or more): Anorexia (52%), weight decreased (39%)

Musculoskeletal

Very common (10% or more): Rigors (12%)
Post-marketing surveillance: Myopathy, including rhabdomyolysis, in combination with statin therapy

Nervous system

Very common (10% or more): Headache (15%), neuropathy (13%)

Psychiatric

Very common (10% or more): Depression (19%)

References

1. Liu V, White DA, Zakowski MF, et al. "Pulmonary toxicity associated with erlotinib." Chest 132 (2007): 1042-4

2. "Product Information. Tarceva (erlotinib)." Genentech, South San Francisco, CA.

3. Marquez G, Herrera-Acosta E, Vidal I, Galvany L, Iglesias M, Umbert P "A case of trichomegaly of the eyelashes and facial hypertrichosis induced by erlotinib (Tarceva)." Int J Dermatol 48 (2009): 97-8

4. Cuetara MS, Aguilar A, Martin L, Aspiroz C, Del Palacio A "Erlotinib associated with rosacea-like folliculitis and Malassezia sympodialis." Br J Dermatol 155 (2006): 477-9

5. PharmaLive "Skin rash actually signifies better outcomes for pancreatic and lung cancer patients. Available from: URL: http://pharmalive.com/news/Print.cfm?articleid=456520" ([2007 Jul 3]):

6. Pellegrinotti M, Fimognari FL, Franco A, Repetto L, Pastorelli R "Erlotinib-induced hepatitis complicated by fatal lactic acidosis in an elderly man with lung cancer." Ann Pharmacother 43 (2009): 542-5

7. Lee SM, Buchler T, Joseph T, Lai C "Bilateral eardrum perforation after long-term treatment with erlotinib." J Clin Oncol 26 (2008): 2582-4

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