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Tarceva Side Effects

Generic name: erlotinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 21, 2022.

Note: This document contains side effect information about erlotinib. Some of the dosage forms listed on this page may not apply to the brand name Tarceva.

Summary

Common side effects of Tarceva include: infection, conjunctivitis, diarrhea, dyspnea, keratoconjunctivitis, nausea, pruritus, skin rash, stomatitis, anorexia, and xeroderma. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to erlotinib: oral tablets

Side effects include:

First-line therapy for NSCLC: Rash, diarrhea, cough, dyspnea, dry skin, back pain, chest pain, conjunctivitis, mucosal inflammation, pruritus, paronychia, arthralgia, musculoskeletal pain.

Second-line or subsequent therapy for NSCLC: Rash, diarrhea, anorexia, fatigue, dyspnea, nausea, infection, stomatitis, pruritus, dry skin, conjunctivitis, keratoconjunctivitis sicca.

Maintenance therapy for NSCLC: Rash, diarrhea.

Combination therapy with gemcitabine for pancreatic cancer: rash, diarrhea, decreased weight, infection, pyrexia, stomatitis, depression, cough, headache.

For Healthcare Professionals

Applies to erlotinib: oral tablet

Respiratory

Very common (10% or more): Dyspnea (41%), cough (33%)

Common (1% to 10%): Epistaxis, interstitial lung disease[Ref]

Dermatologic

Very common (10% or more): Rash (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 (SJS), toxic epidermal necrolysis (TEN)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (54%), nausea (33%), vomiting (23%), stomatitis (22%), dyspepsia (17%), flatulence (13%), abdominal pain (11%)

Common (1% to 10%): GI bleeding

Uncommon (0.1% to 1%): GI 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]

Immunologic

Very common (10% or more): Infections (24%)[Ref]

Ocular

Very common (10% or more): Keratoconjunctivitis sicca (12%), conjunctivitis (12%)

Common (1% to 10%): Keratitis

Uncommon (0.1% to 1%): Eyelash changes

Rare (less than 0.1%): Corneal ulcerations or perforations

Postmarketing reports: Uveitis[Ref]

Renal

Common (1% to 10%): Renal insufficiency

Uncommon (0.1% to 1%): Nephritis, proteinuria

Other

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

Cardiovascular

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

Metabolic

Very common (10% or more): Anorexia (53%), weight decreased (39%)

Musculoskeletal

Very common (10% or more): Rigors (12%)

Postmarketing reports: 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. "Product Information. Tarceva (erlotinib)." Genentech (2004):

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

3. 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

4. PharmaLive "Skin rash actually signifies better outcomes for pancreatic and lung cancer patients. http://pharmalive.com/news/Print.cfm?articleid=456520" (2007):

5. 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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.