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Erlotinib Side Effects

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Common Erlotinib Side Effects


The most commonly reported Erlotinib side effects (click to view or check a box to report):

Death (1006)
Diarrhoea (642)
Malignant Neoplasm Progression (633)
Rash (487)
Anaemia (370)
Dehydration (363)
Dyspnoea (323)
Pneumonia (286)
Nausea (280)
Disease Progression (263)
Haemoglobin Decreased (246)
Decreased Appetite (224)
Fatigue (221)
Pleural Effusion (219)
Pyrexia (218)
Asthenia (209)
Vomiting (209)
Incorrect Dose Administered (209)
Pulmonary Embolism (205)
Off Label Use (189)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Erlotinib Side Effects Reported to FDA



Erlotinib Side Effect Report#9999264
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: lung neoplasm malignant, who was treated with Erlotinib Tablet (dosage: 150 Mg, 3xweekly, start time:
Oct 24, 2012), combined with:
  • Vitamin E /00110501/
  • Oxybutynin /00538902/ (Unk)
  • Evoxac
  • Cymbalta
  • Levothyroxin
  • Gabapentin
  • Mycophenolate
  • Sertraline /01011402/
and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in female patients, resulting in Death side effect.
Erlotinib Side Effect Report#9999261
Loss Of Consciousness, Weight Decreased
This report suggests a potential Erlotinib Tablet Loss Of Consciousness side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Erlotinib Tablet (dosage: 150 Mg, Uid/qd) starting
Jan 08, 2012. After starting Erlotinib Tablet the patient began experiencing various side effects, including: Loss Of Consciousness, Weight DecreasedAdditional drugs used concurrently:
  • Norco (Unk)
  • Glimepiride (Unk)
  • Pennsaid (Unk)
  • Spiriva (Unk)
  • Lisinopril
  • Meloxicam
  • Lactaid
  • Prednisone
Although Erlotinib Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Loss Of Consciousness, may still occur.
Erlotinib Side Effect Report#9995271
Diarrhoea
This Death problem was reported by a consumer or non-health professional from US. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Erlotinib Tablet (dosage: 150 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Erlotinib Tablet, the patient experienced the following unwanted symptoms/side effects: DiarrhoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Erlotinib Side Effect Report#9995269
This Death side effect was reported by a consumer or non-health professional from US. A 80-year-old male patient (weight:NA) experienced the following symptoms/conditions: lung neoplasm malignant.The patient was prescribed Erlotinib Tablet (drug dosage: 150 Mg, Uid/qd), which was initiated on
Feb 18, 2010. Concurrently used drugs:
  • Metformin /00082702/ (Unk)
  • Zestril (Unk)
  • Xalatan (Unk)
  • Aspirin (Unk)
.After starting to take Erlotinib Tablet the consumer reported adverse symptoms, such as: These side effects may potentially be related to Erlotinib Tablet.
Erlotinib Side Effect Report#9995268
Dysgeusia
This is a report of a 77-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Erlotinib Tablet (dosage: 150 Mg, Uid/qd, start time:
May 01, 2012), combined with: NA. and developed a serious reaction and side effect(s): Dysgeusia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in female patients, resulting in Death side effect.
Erlotinib Side Effect Report#9995266
This report suggests a potential Erlotinib Tablet Death side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bronchial carcinoma and used Erlotinib Tablet (dosage: 150 Mg, Uid/qd) starting
Apr 25, 2012. After starting Erlotinib Tablet the patient began experiencing various side effects, including:Additional drugs used concurrently:
  • Alimta
  • Keppra
  • Folic Acid (Unk)
  • Hydrocodone Hydrochloride (Unk)
  • Homatropine (Unk)
Although Erlotinib Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Erlotinib Side Effect Report#9995263
This Death problem was reported by a consumer or non-health professional from ID. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pancreatic carcinoma. On NS this consumer started treatment with Erlotinib Tablet (dosage: Unk). The following drugs were being taken at the same time: NA. When using Erlotinib Tablet, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Erlotinib Side Effect Report#9981117
Cerebral Disorder, Aphasia, Disease Progression
This Cerebral Disorder side effect was reported by a consumer or non-health professional from CN. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Erlotinib Tablet (drug dosage: 150 Mg, Uid/qd), which was initiated on
Jul 06, 2012. Concurrently used drugs: NA..After starting to take Erlotinib Tablet the consumer reported adverse symptoms, such as: Cerebral Disorder, Aphasia, Disease ProgressionThese side effects may potentially be related to Erlotinib Tablet.
Erlotinib Side Effect Report#9981106
Bone Pain
This is a report of a 67-year-old male patient (weight: NA) from CN, suffering from the following health symptoms/conditions: non-small cell lung cancer, who was treated with Erlotinib Tablet (dosage: 150 Mg, Uid/qd, start time:
Feb 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Bone Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in male patients, resulting in Bone Pain side effect.
Erlotinib Side Effect Report#9981099
Hypertension
This report suggests a potential Erlotinib Tablet Hypertension side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: non-small cell lung cancer and used Erlotinib Tablet (dosage: 150 Mg, Uid/qd) starting
Nov 27, 2013. After starting Erlotinib Tablet the patient began experiencing various side effects, including: HypertensionAdditional drugs used concurrently:
  • Bevacizumab (15 Mg/kg, Every 21 Days)
Although Erlotinib Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypertension, may still occur.
Erlotinib Side Effect Report#9981078
Productive Cough
This Death problem was reported by a consumer or non-health professional from CN. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Nov 18, 2009 this consumer started treatment with Erlotinib Tablet (dosage: 150 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Erlotinib Tablet, the patient experienced the following unwanted symptoms/side effects: Productive CoughThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Erlotinib Side Effect Report#9970191
Organ Failure, Metastases To Lung, Interstitial Lung Disease
This Organ Failure side effect was reported by a consumer or non-health professional from CN. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Erlotinib Tablet (drug dosage: 150 Mg, Uid/qd), which was initiated on
Aug 17, 2012. Concurrently used drugs: NA..After starting to take Erlotinib Tablet the consumer reported adverse symptoms, such as: Organ Failure, Metastases To Lung, Interstitial Lung DiseaseThese side effects may potentially be related to Erlotinib Tablet.
Erlotinib Side Effect Report#9970185
This is a report of a 71-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Erlotinib Tablet (dosage: 150 Mg, Uid/qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in male patients, resulting in Death side effect.
Erlotinib Side Effect Report#9970166
Anaemia, Malignant Neoplasm Progression, Rash, Diarrhoea
This report suggests a potential Erlotinib Tablet Anaemia side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: non-small cell lung cancer and used Erlotinib Tablet (dosage: Unk) starting NS. After starting Erlotinib Tablet the patient began experiencing various side effects, including: Anaemia, Malignant Neoplasm Progression, Rash, DiarrhoeaAdditional drugs used concurrently: NA. Although Erlotinib Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Erlotinib Side Effect Report#9961440
This Death problem was reported by a consumer or non-health professional from US. A 88-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Erlotinib Tablet (dosage: 150 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Erlotinib Tablet, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Erlotinib Side Effect Report#9961431
Pleuritic Pain
This Pleuritic Pain side effect was reported by a consumer or non-health professional from CN. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Erlotinib Tablet (drug dosage: 150 Mg, Uid/qd), which was initiated on
Sep 27, 2013. Concurrently used drugs: NA..After starting to take Erlotinib Tablet the consumer reported adverse symptoms, such as: Pleuritic PainThese side effects may potentially be related to Erlotinib Tablet. The patient was hospitalized.
Erlotinib Side Effect Report#9961424
Metrorrhagia
This is a report of a 38-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: non-small cell lung cancer, who was treated with Erlotinib Tablet (dosage: 150 Mg, Uid/qd, start time:
May 03, 2013), combined with: NA. and developed a serious reaction and side effect(s): Metrorrhagia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in female patients, resulting in Metrorrhagia side effect. The patient was hospitalized.
Erlotinib Side Effect Report#9961415
This report suggests a potential Erlotinib Tablet Death side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: lung neoplasm malignant and used Erlotinib Tablet (dosage: 150 Mg, Uid/qd) starting NS. After starting Erlotinib Tablet the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Erlotinib Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Erlotinib Side Effect Report#9949836
Organ Failure, Dysuria, Nasopharyngitis, Pyrexia
This Organ Failure problem was reported by a consumer or non-health professional from CN. A 76-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Jun 09, 2013 this consumer started treatment with Erlotinib Tablet (dosage: 150 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Erlotinib Tablet, the patient experienced the following unwanted symptoms/side effects: Organ Failure, Dysuria, Nasopharyngitis, PyrexiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Organ Failure, may become evident only after a product is in use by the general population.
Erlotinib Side Effect Report#9949434
Fall, Limb Injury
This Fall side effect was reported by a consumer or non-health professional from CN. A 77-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Erlotinib Tablet (drug dosage: 150 Mg, Uid/qd), which was initiated on
Sep 19, 2013. Concurrently used drugs: NA..After starting to take Erlotinib Tablet the consumer reported adverse symptoms, such as: Fall, Limb InjuryThese side effects may potentially be related to Erlotinib Tablet. The patient was hospitalized.
Erlotinib Side Effect Report#9949150
Eating Disorder, Aphasia, Fall, Lower Limb Fracture, Faecal Incontinence
This is a report of a 73-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: non-small cell lung cancer, who was treated with Erlotinib Tablet (dosage: 150 Mg, Uid/qd, start time:
Jun 18, 2012), combined with: NA. and developed a serious reaction and side effect(s): Eating Disorder, Aphasia, Fall, Lower Limb Fracture, Faecal Incontinence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in female patients, resulting in Eating Disorder side effect.
Erlotinib Side Effect Report#9939159
Motion Sickness, Alopecia, Nasopharyngitis
This report suggests a potential Erlotinib Tablet Motion Sickness side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: non-small cell lung cancer,hypertension,diabetes mellitus and used Erlotinib Tablet (dosage: 150 Mg, Uid/qd) starting 201303. After starting Erlotinib Tablet the patient began experiencing various side effects, including: Motion Sickness, Alopecia, NasopharyngitisAdditional drugs used concurrently:
  • Amlodipine Besylate (5 Mg, Uid/qd)
  • Simvastatin (10 Mg, Uid/qd)
The patient was hospitalized. Although Erlotinib Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Motion Sickness, may still occur.
Erlotinib Side Effect Report#9939136
Cardiac Failure Congestive, Rash
This Cardiac Failure Congestive problem was reported by a consumer or non-health professional from CN. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Dec 12, 2012 this consumer started treatment with Erlotinib Tablet (dosage: 150 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Erlotinib Tablet, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure Congestive, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure Congestive, may become evident only after a product is in use by the general population.
Erlotinib Side Effect Report#9939128
Cardiac Failure
This Cardiac Failure side effect was reported by a consumer or non-health professional from CN. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Erlotinib Tablet (drug dosage: 150 Mg, Uid/qd), which was initiated on
Jun 29, 2012. Concurrently used drugs: NA..After starting to take Erlotinib Tablet the consumer reported adverse symptoms, such as: Cardiac FailureThese side effects may potentially be related to Erlotinib Tablet.
Erlotinib Side Effect Report#9939121
This is a report of a 79-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Erlotinib Tablet (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Erlotinib Tablet treatment in male patients, resulting in Death side effect.


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The appearance of Erlotinib on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Erlotinib Side Effects for Women?

Women Side EffectsReports
Death 379
Diarrhoea 304
Malignant Neoplasm Progression 264
Rash 201
Anaemia 150
Dehydration 138
Dyspnoea 138
Nausea 138
Haemoglobin Decreased 111
Vomiting 110

What are common Erlotinib Side Effects for Men?

Men Side EffectsReports
Death 501
Malignant Neoplasm Progression 360
Diarrhoea 330
Rash 281
Anaemia 216
Dehydration 215
Pneumonia 188
Dyspnoea 182
Disease Progression 163
Pyrexia 153

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Erlotinib reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Erlotinib Safety Alerts, Active Ingredients, Usage Information

    More About Erlotinib

    Side Effects reported to FDA: 5598

    Erlotinib safety alerts: 2009 2008

    Reported deaths: 1382

    Reported hospitalizations: 869

    Tarceva (erlotinib) May 2009

    Audience: Oncological, dermatological and ophthalmological healthcare professionals 

    [Posted 05/08/2009] OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

    [April, 2009 - Dear Healthcare Professional Letter - OSI - Genentech]

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