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Lapatinib Side Effects

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Common Lapatinib Side Effects


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

Diarrhoea (676)
Pyrexia (399)
Neutropenia (342)
Dyspnoea (297)
Nausea (295)
Vomiting (282)
Dehydration (280)
Febrile Neutropenia (210)
Fatigue (177)
Abdominal Pain (159)
Asthenia (150)
Alanine Aminotransferase Increased (143)
Hypokalaemia (134)
Anaemia (110)
Pneumonia (107)
Rash (96)
Aspartate Aminotransferase Increased (94)
Infection (87)
Decreased Appetite (84)
Leukopenia (81)

➢ 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.

Lapatinib Side Effects Reported to FDA



Lapatinib Side Effect Report#9974140
Dizziness
This is a report of a 60-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Lapatinib (dosage: 1000mg Per Day, start time:
Nov 08, 2013), combined with:
  • Paclitaxel (125mg Weekly)
and developed a serious reaction and side effect(s): Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Dizziness side effect. The patient was hospitalized.
Lapatinib Side Effect Report#9974123
Rash, Febrile Neutropenia
This report suggests a potential Lapatinib Rash side effect(s) that can have serious consequences. A female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: breast cancer and used Lapatinib (dosage: 1250mg Per Day) starting
Mar 29, 2010. After starting Lapatinib the patient began experiencing various side effects, including: Rash, Febrile NeutropeniaAdditional drugs used concurrently:
  • Paclitaxel (295.7mg Every 3 Weeks)
  • Myocet (101.4mg Every 3 Weeks)
The patient was hospitalized. Although Lapatinib demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Lapatinib Side Effect Report#9974121
Gastrointestinal Toxicity, Nausea, Vomiting, Diarrhoea, Mucosal Inflammation, Decreased Appetite, Anaemia, Hypokalaemia, Odynophagia
This Gastrointestinal Toxicity problem was reported by a physician from FR. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Jul 23, 2009 this consumer started treatment with Lapatinib (dosage: 750mg Per Day). The following drugs were being taken at the same time:
  • Trastuzumab
  • Paclitaxel
When using Lapatinib, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Toxicity, Nausea, Vomiting, Diarrhoea, Mucosal Inflammation, Decreased Appetite, Anaemia, Hypokalaemia, OdynophagiaThe 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 Gastrointestinal Toxicity, may become evident only after a product is in use by the general population.
Lapatinib Side Effect Report#9943242
Cholecystitis
This Cholecystitis side effect was reported by a physician from DE. A female patient (weight:NA) experienced the following symptoms/conditions: her-2 positive breast cancer.The patient was prescribed Lapatinib (drug dosage: 750mg Per Day), which was initiated on
Dec 05, 2013. Concurrently used drugs:
  • Paclitaxel (150mg Weekly)
  • Trastuzumab (156mg Weekly)
.After starting to take Lapatinib the consumer reported adverse symptoms, such as: CholecystitisThese side effects may potentially be related to Lapatinib. The patient was hospitalized.
Lapatinib Side Effect Report#9943239
Gastroenteritis
This is a report of a 57-year-old female patient (weight: NA) from KR, suffering from the following health symptoms/conditions: breast cancer, who was treated with Lapatinib (dosage: 1250mg Per Day, start time:
Aug 26, 2013), combined with:
  • Capecitabine (2800mg Per Day)
and developed a serious reaction and side effect(s): Gastroenteritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Gastroenteritis side effect. The patient was hospitalized.
Lapatinib Side Effect Report#9943225
Cardiomyopathy
This report suggests a potential Lapatinib Cardiomyopathy side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: breast cancer and used Lapatinib (dosage: 1500mg Per Day) starting 2008. After starting Lapatinib the patient began experiencing various side effects, including: CardiomyopathyAdditional drugs used concurrently:
  • Trastuzumab
  • Epirubicin
Although Lapatinib demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiomyopathy, may still occur.
Lapatinib Side Effect Report#9919770
Pleural Effusion
This Pleural Effusion problem was reported by a physician from ES. A 80-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On NS this consumer started treatment with Lapatinib (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • Trastuzumab (6mgk Every 3 Weeks)
When using Lapatinib, the patient experienced the following unwanted symptoms/side effects: Pleural EffusionThe 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 Pleural Effusion, may become evident only after a product is in use by the general population.
Lapatinib Side Effect Report#9905598
Renal Failure Acute
This Renal Failure Acute side effect was reported by a physician from BR. A 77-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer metastatic.The patient was prescribed Lapatinib (drug dosage: 1500mg Per Day), which was initiated on
Feb 14, 2014. Concurrently used drugs:
  • Exemestane (25mg Per Day)
  • Atenolol
  • Imosec (2mg Every 4 Days)
  • Ondansetron (8mg Per Day)
.After starting to take Lapatinib the consumer reported adverse symptoms, such as: Renal Failure AcuteThese side effects may potentially be related to Lapatinib. The patient was hospitalized.
Lapatinib Side Effect Report#9846611
Pneumonia, Pancytopenia
This is a report of a 52-year-old female patient (weight: NA) from PK, suffering from the following health symptoms/conditions: breast cancer, who was treated with Lapatinib (dosage: 1000mg Per Day, start time:
May 21, 2009), combined with:
  • Trastuzumab (6mgk Per Day)
and developed a serious reaction and side effect(s): Pneumonia, Pancytopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Pneumonia side effect. The patient was hospitalized.
Lapatinib Side Effect Report#9832801
Diarrhoea, Hypokalaemia
This report suggests a potential Lapatinib Diarrhoea side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from IE was diagnosed with the following symptoms/conditions: breast cancer metastatic and used Lapatinib (dosage: 1000mg Per Day) starting 201310. After starting Lapatinib the patient began experiencing various side effects, including: Diarrhoea, HypokalaemiaAdditional drugs used concurrently:
  • Taxol
  • Herceptin
  • Aspirin
  • Lansoprazole
  • Mycostatin (4ml Per Day)
  • Glucophage
  • Loperamide
  • Maxolon (60mg Per Day)
The patient was hospitalized. Although Lapatinib demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Lapatinib Side Effect Report#9808994
Malnutrition
This Malnutrition problem was reported by a physician from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: oesophageal carcinoma. On 199109 this consumer started treatment with Lapatinib (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • 5 Fluorouracil
  • Oxaliplatin
  • Crestor (40mg Per Day)
  • Gemfibrozil (600mg Twice Per Day)
  • Lisinopril (5mg Per Day)
  • Toprol (25mg Per Day)
  • Compazine (10mg As Required)
  • Zofran (8mg As Required)
When using Lapatinib, the patient experienced the following unwanted symptoms/side effects: MalnutritionThe 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 Malnutrition, may become evident only after a product is in use by the general population.
Lapatinib Side Effect Report#9790635
Device Related Infection
This Device Related Infection side effect was reported by a physician from US. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer metastatic.The patient was prescribed Lapatinib (drug dosage: 1000mg Per Day), which was initiated on
Oct 28, 2010. Concurrently used drugs:
  • Herceptin (6mgk Every 3 Weeks)
  • Lorazepam (1mg At Night)
  • Triamcinolone Acetonide
.After starting to take Lapatinib the consumer reported adverse symptoms, such as: Device Related InfectionThese side effects may potentially be related to Lapatinib. The patient was hospitalized.
Lapatinib Side Effect Report#9785860
Parkinsonism
This is a report of a 68-year-old female patient (weight: NA) from ES, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Lapatinib (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Parkinsonism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Parkinsonism side effect. The patient was hospitalized.
Lapatinib Side Effect Report#9756092
Abdominal Pain
This report suggests a potential Lapatinib Abdominal Pain side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: breast cancer and used Lapatinib (dosage: 1000mg Per Day) starting
Nov 06, 2013. After starting Lapatinib the patient began experiencing various side effects, including: Abdominal PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Lapatinib demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Lapatinib Side Effect Report#9750235
Chest Pain, Dyspnoea, Dehydration
This Chest Pain problem was reported by a physician from US. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
Mar 31, 2010 this consumer started treatment with Lapatinib (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • Nab-paclitaxel (100mgm2 Cyclic)
When using Lapatinib, the patient experienced the following unwanted symptoms/side effects: Chest Pain, Dyspnoea, DehydrationThe 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 Chest Pain, may become evident only after a product is in use by the general population.
Lapatinib Side Effect Report#9746389
Mental Status Changes, Diarrhoea
This Mental Status Changes side effect was reported by a physician from US. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: squamous cell carcinoma of head and neck.The patient was prescribed Lapatinib (drug dosage: 1000mg Per Day), which was initiated on
Oct 28, 2013. Concurrently used drugs:
  • Carboplatin
  • Paclitaxel
  • Marijuana
  • Ativan (.5mg Per Day)
  • Gabapentin (100mg Three Times Per Day)
  • Imodium (2mg As Directed)
  • Zofran (8mg Three Times Per Day)
.After starting to take Lapatinib the consumer reported adverse symptoms, such as: Mental Status Changes, DiarrhoeaThese side effects may potentially be related to Lapatinib. The patient was hospitalized.
Lapatinib Side Effect Report#9736104
Febrile Neutropenia
This is a report of a 68-year-old female patient (weight: NA) from KR, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Lapatinib (dosage: 1000mg Per Day, start time:
Jan 18, 2013), combined with:
  • Vinorelbine (200mgm2 Cyclic)
  • Hydrocodone (1tab As Required)
  • Metoclopramide (5mg As Required)
  • Pegaptanib Sodium (300mg Twice Per Day)
  • Nortriptyline (10mg Per Day)
  • Hydrochlorothiazide (25mg Per Day)
  • Amlodipine Besylate (5mg Per Day)
  • Iron Tablets (1tab Twice Per Day)
and developed a serious reaction and side effect(s): Febrile Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Febrile Neutropenia side effect. The patient was hospitalized.
Lapatinib Side Effect Report#9736079
Neutropenia
This report suggests a potential Lapatinib Neutropenia side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: breast cancer metastatic and used Lapatinib (dosage: 8750mg Cumulative Dose) starting
Mar 02, 2011. After starting Lapatinib the patient began experiencing various side effects, including: NeutropeniaAdditional drugs used concurrently:
  • Docetaxel (112.5mg Per Day)
  • Candesartan
  • Trospium Chloride
  • Xanax (1tab Twice Per Day)
  • Xanax (1tab Per Day)
  • Vogalene (2tab Three Times Per Day)
  • Zophren (8mg Per Day)
  • Zophren (8mg As Required)
Although Lapatinib demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenia, may still occur.
Lapatinib Side Effect Report#9736078
Neutropenia, Neutropenia
This Neutropenia problem was reported by a physician from FR. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
Sep 23, 2010 this consumer started treatment with Lapatinib (dosage: 44000mg Cumulative Dose). The following drugs were being taken at the same time:
  • Docetaxel (128mg Cyclic)
  • Crestor
  • Micardis
  • Stilnox
  • Xanax
  • Atarax
  • Dafalgan
  • Imodium
When using Lapatinib, the patient experienced the following unwanted symptoms/side effects: Neutropenia, NeutropeniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neutropenia, may become evident only after a product is in use by the general population.
Lapatinib Side Effect Report#9733608
Diarrhoea, Hypokalaemia
This Diarrhoea side effect was reported by a physician from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer metastatic.The patient was prescribed Lapatinib (drug dosage: 1000mg Per Day), which was initiated on
Nov 11, 2013. Concurrently used drugs:
  • Trastuzumab (6mgk Every 3 Weeks)
  • Anastrozole (1mg Per Day)
.After starting to take Lapatinib the consumer reported adverse symptoms, such as: Diarrhoea, HypokalaemiaThese side effects may potentially be related to Lapatinib. The patient was hospitalized.
Lapatinib Side Effect Report#9713822
Ejection Fraction Decreased
This is a report of a 44-year-old female patient (weight: NA) from IE, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Lapatinib (dosage: 500mg Per Day, start time:
Jun 23, 2006), combined with:
  • Docetaxel (75mgm2 Cyclic)
  • Trastuzumab (4mgk Weekly)
and developed a serious reaction and side effect(s): Ejection Fraction Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Ejection Fraction Decreased side effect.
Lapatinib Side Effect Report#9667945
Febrile Neutropenia, Neutropenia, Leukopenia, Oral Pain
This report suggests a potential Lapatinib Febrile Neutropenia side effect(s) that can have serious consequences. A 31-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: breast cancer and used Lapatinib (dosage: 1500mg Per Day) starting
May 21, 2009. After starting Lapatinib the patient began experiencing various side effects, including: Febrile Neutropenia, Neutropenia, Leukopenia, Oral PainAdditional drugs used concurrently:
  • Paclitaxel (80mgm2 Weekly)
The patient was hospitalized. Although Lapatinib demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Febrile Neutropenia, may still occur.
Lapatinib Side Effect Report#9661051
Cardiac Failure Congestive
This Cardiac Failure Congestive problem was reported by a physician from PH. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Jan 09, 2012 this consumer started treatment with Lapatinib (dosage: 1500mg Per Day). The following drugs were being taken at the same time:
  • Herceptin
When using Lapatinib, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure CongestiveThe 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 Cardiac Failure Congestive, may become evident only after a product is in use by the general population.
Lapatinib Side Effect Report#9657314
Haemorrhage Intracranial
This Haemorrhage Intracranial side effect was reported by a physician from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: neoplasm.The patient was prescribed Lapatinib (drug dosage: 1500mg Per Day), which was initiated on
Oct 18, 2013. Concurrently used drugs:
  • Bevacizumab (600mg Per Day)
  • Warfarin
  • Ondansetron (8mg Three Times Per Day)
.After starting to take Lapatinib the consumer reported adverse symptoms, such as: Haemorrhage IntracranialThese side effects may potentially be related to Lapatinib. The patient was hospitalized.
Lapatinib Side Effect Report#9645989
Colitis Ischaemic, Gastrointestinal Necrosis
This is a report of a 51-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: her-2 positive breast cancer,breast cancer recurrent, who was treated with Lapatinib (dosage: 1250mg Per Day, start time:
Aug 15, 2013), combined with:
  • Capecitabine (3300mg Per Day)
  • Trastuzumab
and developed a serious reaction and side effect(s): Colitis Ischaemic, Gastrointestinal Necrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lapatinib treatment in female patients, resulting in Colitis Ischaemic side effect.


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The appearance of Lapatinib 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 Lapatinib Side Effects for Women?

Women Side EffectsReports
Diarrhoea 627
Pyrexia 365
Neutropenia 317
Nausea 270
Dyspnoea 265
Vomiting 256
Dehydration 251
Febrile Neutropenia 180
Fatigue 150
Alanine Aminotransferase Increased 140

What are common Lapatinib Side Effects for Men?

Men Side EffectsReports
Diarrhoea 47
Pyrexia 34
Pneumonia 32
Dyspnoea 31
Febrile Neutropenia 30
Dehydration 29
Fatigue 27
Nausea 25
Vomiting 25
Neutropenia 24

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.

    Lapatinib 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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    More About Lapatinib

    Side Effects reported to FDA: 3254

    Lapatinib safety alerts: No

    Reported deaths: 240

    Reported hospitalizations: 2393

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