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Iressa Side Effects

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Common Iressa Side Effects


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

Diarrhoea (379)
Rash (270)
Interstitial Lung Disease (182)
Hepatic Function Abnormal (168)
Lung Disorder (143)
Pyrexia (142)
Pneumonia (140)
Disease Progression (132)
Nausea (130)
Dyspnoea (130)
Vomiting (102)
Dry Skin (101)
Liver Disorder (101)
Anaemia (85)
Anorexia (82)
Dehydration (77)
Cough (74)
Respiratory Failure (73)
Fatigue (64)
Alanine Aminotransferase Increased (63)

➢ 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.

Iressa Side Effects Reported to FDA



Iressa Side Effect Report#9250506
Cellulitis
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breast cancer, who was treated with Iressa (dosage: NA, start time:
Aug 10, 2006), combined with:
  • Arimidex
and developed a serious reaction and side effect(s): Cellulitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in female patients, resulting in Cellulitis side effect. The patient was hospitalized.
Iressa Side Effect Report#8815357
Multiple Fractures, Dyspnoea, Bronchitis, Pain, Arthritis, Neuropathy Peripheral, Arthralgia, Hypoaesthesia
This report suggests a potential Iressa Multiple Fractures side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Iressa (dosage: NA) starting NS. After starting Iressa the patient began experiencing various side effects, including: Multiple Fractures, Dyspnoea, Bronchitis, Pain, Arthritis, Neuropathy Peripheral, Arthralgia, HypoaesthesiaAdditional drugs used concurrently:
  • Prilosec
  • Vitamin B12 (1000 Mcg/ Ml, Inject 1 Ml To Area As Directed Every 30 Days)
  • Flaxseed Oil (Take By Mouth Daily)
  • Aspirin
  • Phenergan W/ Codeine (6.25/ 10 Mg/ 5ml By Mouth Every 6 Hours)
  • Cardizem
  • Vitamin C
  • Megace (40 Mg/ Ml, Take 5-20 Ml Titrated To Appetite Improvement)
Although Iressa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Multiple Fractures, may still occur.
Iressa Side Effect Report#8478514-7
Hepatic Function Abnormal
This Hepatic Function Abnormal problem was reported by a consumer or non-health professional from Japan. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Dec 07, 2010 this consumer started treatment with Iressa (dosage: 250 Mg, Unk). The following drugs were being taken at the same time:
  • Alimta (300 Mg/m2, Unk)
When using Iressa, the patient experienced the following unwanted symptoms/side effects: Hepatic Function AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Function Abnormal, may become evident only after a product is in use by the general population.
Iressa Side Effect Report#8376706-9
Lung Disorder
This Lung Disorder side effect was reported by a health professional from Japan. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Iressa (drug dosage: NA), which was initiated on
Jun 18, 2011. Concurrently used drugs: NA..After starting to take Iressa the consumer reported adverse symptoms, such as: Lung DisorderThese side effects may potentially be related to Iressa.
Iressa Side Effect Report#8354922-X
Hepatitis
This is a report of a 77-year-old female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Iressa (dosage: NA, start time:
Oct 01, 2010), combined with: NA. and developed a serious reaction and side effect(s): Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in female patients, resulting in Hepatitis side effect.
Iressa Side Effect Report#8345599-8
Haemoptysis, Ventricular Fibrillation, Pneumopericardium
This report suggests a potential Iressa Haemoptysis side effect(s) that can have serious consequences. A male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: lung adenocarcinoma metastatic and used Iressa (dosage: Dosage Is Uncertain.) starting
Jun 30, 2011. After starting Iressa the patient began experiencing various side effects, including: Haemoptysis, Ventricular Fibrillation, PneumopericardiumAdditional drugs used concurrently:
  • Avastin
  • Aspirin
  • Zolpidem
  • Mucodyne
  • Loxonin
  • Carboplatin
  • Paclitaxel
  • Avastin
The patient was hospitalized. Although Iressa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemoptysis, may still occur.
Iressa Side Effect Report#8315300-2
Spinal Compression Fracture, Pathological Fracture, Osteogenesis Imperfecta, Fall
This Spinal Compression Fracture problem was reported by a pharmacist from Japan. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 28, 2011 this consumer started treatment with Iressa (dosage: 250 Mg, 1x/day). The following drugs were being taken at the same time:
  • Cortril (10 Mg, 1x/day)
When using Iressa, the patient experienced the following unwanted symptoms/side effects: Spinal Compression Fracture, Pathological Fracture, Osteogenesis Imperfecta, FallThe 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 Spinal Compression Fracture, may become evident only after a product is in use by the general population.
Iressa Side Effect Report#8287377-4
Lumbar Vertebral Fracture, Back Pain, Pain In Extremity, Spinal Compression Fracture, Pathological Fracture
This Lumbar Vertebral Fracture side effect was reported by a pharmacist from Japan. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: lung neoplasm malignant.The patient was prescribed Iressa (drug dosage: 250 Mg, Alternate Day), which was initiated on
Aug 19, 2011. Concurrently used drugs: NA..After starting to take Iressa the consumer reported adverse symptoms, such as: Lumbar Vertebral Fracture, Back Pain, Pain In Extremity, Spinal Compression Fracture, Pathological FractureThese side effects may potentially be related to Iressa. The patient was hospitalized.
Iressa Side Effect Report#8237844-4
Cytolytic Hepatitis
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: lung neoplasm malignant,diarrhoea, who was treated with Iressa (dosage: NA, start time:
Jan 25, 2011), combined with:
  • Imodium
and developed a serious reaction and side effect(s): Cytolytic Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in female patients, resulting in Cytolytic Hepatitis side effect.
Iressa Side Effect Report#8174513-3
Bone Marrow Failure
This report suggests a potential Iressa Bone Marrow Failure side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: lung neoplasm malignant and used Iressa (dosage: NA) starting NS. After starting Iressa the patient began experiencing various side effects, including: Bone Marrow FailureAdditional drugs used concurrently: NA. Although Iressa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bone Marrow Failure, may still occur.
Iressa Side Effect Report#8127989-1
Pulmonary Embolism, Thrombosis
This Pulmonary Embolism problem was reported by a physician from Germany. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Jan 18, 2010 this consumer started treatment with Iressa (dosage: NA). The following drugs were being taken at the same time:
  • Novalgin
  • Durugesic Pflaster
  • Astonin H
  • Nystatin (1 Pipette 6 Times A Day)
  • Movicol Bentel
  • Vomacur
  • Pantoprazole
When using Iressa, the patient experienced the following unwanted symptoms/side effects: Pulmonary Embolism, ThrombosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Embolism, may become evident only after a product is in use by the general population.
Iressa Side Effect Report#8105743-4
Cytolytic Hepatitis
This Cytolytic Hepatitis side effect was reported by a physician from France. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Iressa (drug dosage: NA), which was initiated on
Oct 08, 2011. Concurrently used drugs: NA..After starting to take Iressa the consumer reported adverse symptoms, such as: Cytolytic HepatitisThese side effects may potentially be related to Iressa. The patient was hospitalized.
Iressa Side Effect Report#8074827-1
Respiratory Failure, Off Label Use
This is a report of a 69-year-old male patient (weight: NA) from Brazil, suffering from the following health symptoms/conditions: lung neoplasm malignant, who was treated with Iressa (dosage: NA, start time:
Aug 01, 2011), combined with: NA. and developed a serious reaction and side effect(s): Respiratory Failure, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in male patients, resulting in Respiratory Failure side effect. The patient was hospitalized.
Iressa Side Effect Report#8064550-1
Gastric Ulcer
This report suggests a potential Iressa Gastric Ulcer side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: lung neoplasm malignant and used Iressa (dosage: NA) starting NS. After starting Iressa the patient began experiencing various side effects, including: Gastric UlcerAdditional drugs used concurrently: NA.The patient was hospitalized. Although Iressa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastric Ulcer, may still occur.
Iressa Side Effect Report#8056846-4
Haemoptysis
This Haemoptysis problem was reported by a physician from Korea, Republic Of. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Apr 15, 2011 this consumer started treatment with Iressa (dosage: NA). The following drugs were being taken at the same time:
  • Alimta
  • Cisplatin
When using Iressa, the patient experienced the following unwanted symptoms/side effects: HaemoptysisThe 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 Haemoptysis, may become evident only after a product is in use by the general population.
Iressa Side Effect Report#8049280-4
Pneumatosis Intestinalis
This Pneumatosis Intestinalis side effect was reported by a physician from Japan. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Iressa (drug dosage: NA), which was initiated on
Dec 27, 2006. Concurrently used drugs: NA..After starting to take Iressa the consumer reported adverse symptoms, such as: Pneumatosis IntestinalisThese side effects may potentially be related to Iressa. The patient was hospitalized.
Iressa Side Effect Report#8022323-X
Dermatitis Acneiform, Hepatic Function Abnormal
This is a report of a 74-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Iressa (dosage: NA, start time:
Sep 20, 2011), combined with:
  • Urso 250
  • Verapamil Hcl
and developed a serious reaction and side effect(s): Dermatitis Acneiform, Hepatic Function Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in female patients, resulting in Dermatitis Acneiform side effect.
Iressa Side Effect Report#8013983-8
Pericardial Effusion, Odynophagia
This report suggests a potential Iressa Pericardial Effusion side effect(s) that can have serious consequences. A 44-year-old patient (weight: NA) from Australia was diagnosed with the following symptoms/conditions: NA and used Iressa (dosage: NA) starting NS. After starting Iressa the patient began experiencing various side effects, including: Pericardial Effusion, OdynophagiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Iressa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pericardial Effusion, may still occur.
Iressa Side Effect Report#8013796-7
Haematochezia
This Haematochezia problem was reported by a physician from Japan. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Iressa (dosage: NA). The following drugs were being taken at the same time: NA. When using Iressa, the patient experienced the following unwanted symptoms/side effects: HaematocheziaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haematochezia, may become evident only after a product is in use by the general population.
Iressa Side Effect Report#8008555-5
Confusional State
This Confusional State side effect was reported by a physician from Spain. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: non-small cell lung cancer.The patient was prescribed Iressa (drug dosage: 250 Mg 3x10 Film Coated Tablets), which was initiated on
Oct 05, 2011. Concurrently used drugs: NA..After starting to take Iressa the consumer reported adverse symptoms, such as: Confusional StateThese side effects may potentially be related to Iressa.
Iressa Side Effect Report#8008305-2
Myocardial Infarction, Lower Respiratory Tract Infection
This is a report of a 81-year-old female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: lung neoplasm malignant, who was treated with Iressa (dosage: NA, start time:
Aug 01, 2011), combined with:
  • Isosorbide Mononitrate
  • Laxido
  • Quinine Sulfate
  • Carbocysteine
  • Clopidogrel
  • Enoxaparin
  • Ferrous Sulfate Tab
  • Folic Acid
and developed a serious reaction and side effect(s): Myocardial Infarction, Lower Respiratory Tract Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in female patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.
Iressa Side Effect Report#8005900-1
Gastrointestinal Perforation
This report suggests a potential Iressa Gastrointestinal Perforation side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Iressa (dosage: NA) starting NS. After starting Iressa the patient began experiencing various side effects, including: Gastrointestinal PerforationAdditional drugs used concurrently: NA. Although Iressa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastrointestinal Perforation, may still occur.
Iressa Side Effect Report#8004071-5
Cell Marker Increased, Pyrexia
This Cell Marker Increased problem was reported by a pharmacist from Japan. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: lung neoplasm malignant. On
May 01, 2011 this consumer started treatment with Iressa (dosage: NA). The following drugs were being taken at the same time: NA. When using Iressa, the patient experienced the following unwanted symptoms/side effects: Cell Marker Increased, 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 Cell Marker Increased, may become evident only after a product is in use by the general population.
Iressa Side Effect Report#7999648-7
Cell Marker Increased
This Cell Marker Increased side effect was reported by a physician from Japan. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: lung neoplasm malignant.The patient was prescribed Iressa (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Iressa the consumer reported adverse symptoms, such as: Cell Marker IncreasedThese side effects may potentially be related to Iressa.
Iressa Side Effect Report#7996478-7
Gastrointestinal Necrosis, Immunodeficiency
This is a report of a 85-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: lung neoplasm malignant, who was treated with Iressa (dosage: NA, start time:
Jun 01, 2011), combined with: NA. and developed a serious reaction and side effect(s): Gastrointestinal Necrosis, Immunodeficiency after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Iressa treatment in female patients, resulting in Gastrointestinal Necrosis side effect.


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The appearance of Iressa 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 Iressa Side Effects for Women?

Women Side EffectsReports
Diarrhoea 244
Rash 155
Hepatic Function Abnormal 117
Liver Disorder 81
Dry Skin 79
Disease Progression 74
Interstitial Lung Disease 74
Pyrexia 73
Nausea 72
Vomiting 67

What are common Iressa Side Effects for Men?

Men Side EffectsReports
Diarrhoea 134
Rash 114
Interstitial Lung Disease 108
Pneumonia 77
Lung Disorder 76
Pyrexia 69
Dyspnoea 68
Disease Progression 58
Nausea 58
Hepatic Function Abnormal 49

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.

    Iressa 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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    Iressa Safety Alerts, Active Ingredients, Usage Information

    NDC0310-0482
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameIRESSA
    NameGefitinib
    Dosage FormTABLET, COATED
    RouteORAL
    On market since20030513
    LabelerAstraZeneca Pharmaceuticals LP
    Active Ingredient(s)GEFITINIB
    Strength(s)250
    Unit(s)mg/1
    Pharma ClassKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

    Iressa Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3055

    Iressa safety alerts: 2005

    Reported deaths: 652

    Reported hospitalizations: 1536

    Iressa (gefitinib)

    Audience: Oncology healthcare professionals

    AstraZeneca and FDA notified healthcare professionals of new approved labeling for Iressa that states the medicine should be used only in cancer patients who have already taken the medicine and whose doctor believes it is helping them. New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer.

    [June 17, 2005 - Public Health Advisory - FDA]
    [June 17, 2005 - Drug Information Page - FDA]

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