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Trabectedin Side Effects

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Common Trabectedin Side Effects


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

Pyrexia (9)
Neutropenic Sepsis (9)
Neutropenia (9)
Pancytopenia (8)
Hepatic Enzyme Increased (6)
Renal Failure Acute (6)
Nausea (5)
Leukopenia (5)
Vomiting (5)
White Blood Cell Count Decreased (5)
Gastrointestinal Haemorrhage (4)
Blood Creatine Phosphokinase Increased (4)
Blood Creatinine Increased (4)
Septic Shock (4)
Thrombocytopenia (4)
Pleural Effusion (3)
Multi-organ Failure (3)
Rhabdomyolysis (3)
Syncope Vasovagal (3)
Pulmonary Oedema (3)

➢ 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.

Trabectedin Side Effects Reported to FDA



Trabectedin Side Effect Report#9029791
Hepatitis, Febrile Neutropenia
This is a report of a 59-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Trabectedin (dosage: NA, start time: NS), combined with:
  • Caelyx
and developed a serious reaction and side effect(s): Hepatitis, Febrile Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in female patients, resulting in Hepatitis side effect.
Trabectedin Side Effect Report#8433317-4
Bone Marrow Failure
This report suggests a potential Trabectedin Bone Marrow Failure side effect(s) that can have serious consequences. A female patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: ovarian cancer recurrent and used Trabectedin (dosage: Cycle 3 On Day 1 (total Dose Administered, 1.0 Mg), In 500 Ml Nacl (3 Hour)) starting
May 08, 2012. After starting Trabectedin the patient began experiencing various side effects, including: Bone Marrow FailureAdditional drugs used concurrently: NA. Although Trabectedin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bone Marrow Failure, may still occur.
Trabectedin Side Effect Report#8394523-0
Mallory-weiss Syndrome, Gastrooesophageal Reflux Disease, Urinary Tract Infection, Oesophagitis, Dyspnoea, Pyrexia, Pneumonia Klebsiella, Leukopenia
This Mallory-weiss Syndrome problem was reported by a physician from Germany. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: condition aggravated. On
Oct 19, 2011 this consumer started treatment with Trabectedin (dosage: NA). The following drugs were being taken at the same time:
  • Doxorubicin Hcl
When using Trabectedin, the patient experienced the following unwanted symptoms/side effects: Mallory-weiss Syndrome, Gastrooesophageal Reflux Disease, Urinary Tract Infection, Oesophagitis, Dyspnoea, Pyrexia, Pneumonia Klebsiella, LeukopeniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mallory-weiss Syndrome, may become evident only after a product is in use by the general population.
Trabectedin Side Effect Report#8393339-9
Pyrexia, Aspergilloma, Gastrooesophageal Reflux Disease, Pneumonia Klebsiella, Leukopenia, Hypertensive Crisis, Oesophagitis, Dyspnoea, Mallory-weiss Syndrome
This Pyrexia side effect was reported by a physician from Germany. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: condition aggravated.The patient was prescribed Trabectedin (drug dosage: NA), which was initiated on
Oct 19, 2011. Concurrently used drugs:
  • Doxorubicin Hcl
.After starting to take Trabectedin the consumer reported adverse symptoms, such as: Pyrexia, Aspergilloma, Gastrooesophageal Reflux Disease, Pneumonia Klebsiella, Leukopenia, Hypertensive Crisis, Oesophagitis, Dyspnoea, Mallory-weiss SyndromeThese side effects may potentially be related to Trabectedin.
Trabectedin Side Effect Report#8366622-0
Sarcoma, Gastrointestinal Haemorrhage, Haematemesis, Pancytopenia, Neutropenic Sepsis, Hepatic Enzyme Increased, Pulmonary Oedema, Multi-organ Failure
This is a report of a 71-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: liposarcoma, who was treated with Trabectedin (dosage: Cycle One, 2280 Ug, start time:
Feb 05, 2012), combined with:
  • Corticosteroids
  • Gentamicin
  • Nystatin (4 Ml;)
and developed a serious reaction and side effect(s): Sarcoma, Gastrointestinal Haemorrhage, Haematemesis, Pancytopenia, Neutropenic Sepsis, Hepatic Enzyme Increased, Pulmonary Oedema, Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in male patients, resulting in Sarcoma side effect. The patient was hospitalized.
Trabectedin Side Effect Report#8346934-7
Multi-organ Failure, Neutropenic Sepsis, Pulmonary Oedema, Fatigue, Pancytopenia, White Blood Cell Count Decreased, Blood Bilirubin Increased, Liposarcoma Metastatic, Hepatic Enzyme Increased
This report suggests a potential Trabectedin Multi-organ Failure side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Trabectedin (dosage: 1200 Ug/m2, Unk) starting
Jan 05, 2012. After starting Trabectedin the patient began experiencing various side effects, including: Multi-organ Failure, Neutropenic Sepsis, Pulmonary Oedema, Fatigue, Pancytopenia, White Blood Cell Count Decreased, Blood Bilirubin Increased, Liposarcoma Metastatic, Hepatic Enzyme IncreasedAdditional drugs used concurrently:
  • Warfarin Sodium
The patient was hospitalized. Although Trabectedin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Multi-organ Failure, may still occur.
Trabectedin Side Effect Report#8305314-0
Pancytopenia, Hepatic Enzyme Increased, Multi-organ Failure, Pulmonary Oedema, Sarcoma, Gastrointestinal Haemorrhage, Neutropenic Sepsis
This Pancytopenia problem was reported by a physician from United Kingdom. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 05, 2012 this consumer started treatment with Trabectedin (dosage: Cycle Two, 2280 Ug). The following drugs were being taken at the same time:
  • Warfarin Sodium
When using Trabectedin, the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Hepatic Enzyme Increased, Multi-organ Failure, Pulmonary Oedema, Sarcoma, Gastrointestinal Haemorrhage, Neutropenic SepsisThe 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 Pancytopenia, may become evident only after a product is in use by the general population.
Trabectedin Side Effect Report#8294693-9
Hepatic Enzyme Increased
This Hepatic Enzyme Increased side effect was reported by a physician from Kazakhstan. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: ovarian cancer.The patient was prescribed Trabectedin (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Doxorubicin Hydrochloride
.After starting to take Trabectedin the consumer reported adverse symptoms, such as: Hepatic Enzyme IncreasedThese side effects may potentially be related to Trabectedin.
Trabectedin Side Effect Report#8221507-5
Hypotension, Anaemia, Gastrointestinal Haemorrhage, Hepatic Enzyme Increased, Condition Aggravated, White Blood Cell Count Decreased, Alanine Aminotransferase Increased, Fatigue
This is a report of a 71-year-old male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: liposarcoma,atrial fibrillation, who was treated with Trabectedin (dosage: 1200 Ug/m2, Unk, start time:
Jan 26, 2012), combined with:
  • Warfarin Sodium
and developed a serious reaction and side effect(s): Hypotension, Anaemia, Gastrointestinal Haemorrhage, Hepatic Enzyme Increased, Condition Aggravated, White Blood Cell Count Decreased, Alanine Aminotransferase Increased, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in male patients, resulting in Hypotension side effect. The patient was hospitalized.
Trabectedin Side Effect Report#8209210-9
Tachycardia, Pancytopenia, Gastrointestinal Haemorrhage, Blood Bilirubin Increased, White Blood Cell Count Decreased, Alanine Aminotransferase Increased, Neutropenic Sepsis, Blood Alkaline Phosphatase Increased, Thrombocytopenia
This report suggests a potential Trabectedin Tachycardia side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: liposarcoma,atrial fibrillation and used Trabectedin (dosage: 1200 Ug/m2, Unk) starting
Jan 26, 2012. After starting Trabectedin the patient began experiencing various side effects, including: Tachycardia, Pancytopenia, Gastrointestinal Haemorrhage, Blood Bilirubin Increased, White Blood Cell Count Decreased, Alanine Aminotransferase Increased, Neutropenic Sepsis, Blood Alkaline Phosphatase Increased, ThrombocytopeniaAdditional drugs used concurrently:
  • Warfarin Sodium
The patient was hospitalized. Although Trabectedin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tachycardia, may still occur.
Trabectedin Side Effect Report#8030616-5
Hyperkalaemia, Renal Failure Acute
This Hyperkalaemia problem was reported by a physician from France. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: sarcoma,pain in extremity,hypertension. On
Nov 29, 2011 this consumer started treatment with Trabectedin (dosage: 24 Hour Infusion). The following drugs were being taken at the same time:
  • Ibuprofen
  • Ramipril
  • Acetaminophen
  • Bisoprolol Fumarate
  • Lyrica
  • Ibuprofen
When using Trabectedin, the patient experienced the following unwanted symptoms/side effects: Hyperkalaemia, Renal Failure AcuteThe 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 Hyperkalaemia, may become evident only after a product is in use by the general population.
Trabectedin Side Effect Report#7997157-2
Rhabdomyolysis
This Rhabdomyolysis side effect was reported by a physician from Germany. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Trabectedin (drug dosage: 1st Cycle Start Date), which was initiated on
Apr 07, 2010. Concurrently used drugs:
  • Dexamethasone
  • Doxorubicin Hydrochloride
  • Dexamethasone
  • Doxorubicin Hydrochloride
  • Kevatril
.After starting to take Trabectedin the consumer reported adverse symptoms, such as: RhabdomyolysisThese side effects may potentially be related to Trabectedin. The patient was hospitalized.
Trabectedin Side Effect Report#7940040-9
White Blood Cell Count Decreased, Blood Creatine Phosphokinase Increased, Liver Function Test Abnormal, Pleural Effusion, Lung Infiltration, Blood Creatinine Increased, Troponin Increased, Anuria, Febrile Neutropenia
This is a report of a male patient (weight: NA) from Norway, suffering from the following health symptoms/conditions: liposarcoma,cardiovascular disorder, who was treated with Trabectedin (dosage: Dose To Be Given Over 24 Hours, start time:
Aug 01, 2011), combined with:
  • Zocor (60 Mg, Unk)
  • Metoprolol Tartrate (100 Mg, Unk)
and developed a serious reaction and side effect(s): White Blood Cell Count Decreased, Blood Creatine Phosphokinase Increased, Liver Function Test Abnormal, Pleural Effusion, Lung Infiltration, Blood Creatinine Increased, Troponin Increased, Anuria, Febrile Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in male patients, resulting in White Blood Cell Count Decreased side effect.
Trabectedin Side Effect Report#7850961-3
Neuropathy Peripheral
This report suggests a potential Trabectedin Neuropathy Peripheral side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: ovarian cancer and used Trabectedin (dosage: NA) starting NS. After starting Trabectedin the patient began experiencing various side effects, including: Neuropathy PeripheralAdditional drugs used concurrently:
  • Doxorubicin Hydrochloride
Although Trabectedin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neuropathy Peripheral, may still occur.
Trabectedin Side Effect Report#7850200-3
Lung Infiltration, Bone Marrow Failure, Renal Failure, Dialysis, Ascites, Pleural Effusion, Rhabdomyolysis
This Lung Infiltration problem was reported by a physician from Norway. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: liposarcoma. On NS this consumer started treatment with Trabectedin (dosage: (3.15 Mg), Intravenous). The following drugs were being taken at the same time:
  • Ramipril
  • Aspirin
  • Simvastatin
  • Zocor
  • Metoprolol Tartrate
  • Corticosteriods
When using Trabectedin, the patient experienced the following unwanted symptoms/side effects: Lung Infiltration, Bone Marrow Failure, Renal Failure, Dialysis, Ascites, Pleural Effusion, RhabdomyolysisThe 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 Lung Infiltration, may become evident only after a product is in use by the general population.
Trabectedin Side Effect Report#7844448-1
Platelet Count Decreased, Blood Creatinine Increased, White Blood Cell Count Decreased, Febrile Neutropenia, Blood Creatine Phosphokinase Increased, Renal Failure Acute, Anuria, Troponin Increased, Liver Function Test Abnormal
This Platelet Count Decreased side effect was reported by a health professional from Norway. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: metastases to lung.The patient was prescribed Trabectedin (drug dosage: Dose To Be Given Over 24 Hours), which was initiated on
Aug 01, 2011. Concurrently used drugs:
  • Ramipril
  • Aspirin
  • Zocor
  • Metoprolol
.After starting to take Trabectedin the consumer reported adverse symptoms, such as: Platelet Count Decreased, Blood Creatinine Increased, White Blood Cell Count Decreased, Febrile Neutropenia, Blood Creatine Phosphokinase Increased, Renal Failure Acute, Anuria, Troponin Increased, Liver Function Test AbnormalThese side effects may potentially be related to Trabectedin. The patient was hospitalized.
Trabectedin Side Effect Report#7817656-3
Carbohydrate Antigen 125 Increased, Hepatotoxicity, Haematotoxicity
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: ovarian epithelial cancer, who was treated with Trabectedin (dosage: Completed Treatement With 6 Trabectedin Infusions, start time: NS), combined with:
  • Doxorubicin Hydrochloride
and developed a serious reaction and side effect(s): Carbohydrate Antigen 125 Increased, Hepatotoxicity, Haematotoxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in female patients, resulting in Carbohydrate Antigen 125 Increased side effect.
Trabectedin Side Effect Report#7790462-4
Ascites, Pleural Effusion, Renal Failure, Liver Function Test Abnormal, Pancytopenia, Rhabdomyolysis, Bone Marrow Failure
This report suggests a potential Trabectedin Death side effect(s) that can have serious consequences. A male patient (weight: NA) from Norway was diagnosed with the following symptoms/conditions: liposarcoma and used Trabectedin (dosage: 3.15 Mg, Unk) starting
Feb 01, 2009. After starting Trabectedin the patient began experiencing various side effects, including: Ascites, Pleural Effusion, Renal Failure, Liver Function Test Abnormal, Pancytopenia, Rhabdomyolysis, Bone Marrow FailureAdditional drugs used concurrently:
  • Simvastatin (Unk)
  • Aspirin
  • Metoprolol
  • Ramipril
  • Zocor
The patient was hospitalized. Although Trabectedin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Trabectedin Side Effect Report#7690730-0
Chest Pain
This Sudden Death problem was reported by a health professional from France. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: liposarcoma. On
Jul 01, 2011 this consumer started treatment with Trabectedin (dosage: NA). The following drugs were being taken at the same time:
  • Minerals Nos
  • Esomeprazole Magnesium
  • Solutions For Parenteral Nutrition
  • Lexomil
  • Atorvastatin Calcium
  • Orocal
  • Ondansertron Hydrochloride
  • Venofer
When using Trabectedin, the patient experienced the following unwanted symptoms/side effects: Chest PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sudden Death, may become evident only after a product is in use by the general population.
Trabectedin Side Effect Report#7608184-9
Oesophagitis Ulcerative
This Oesophagitis Ulcerative side effect was reported by a physician from Italy. A female patient (weight:NA) experienced the following symptoms/conditions: pancreatic carcinoma.The patient was prescribed Trabectedin (drug dosage: NA), which was initiated on
May 19, 2011. Concurrently used drugs:
  • Pantoprazole
  • Nadroparin Calcium
  • Fentanyl
  • Acetaminophen
  • Dexamethasone
  • Fentanyl
.After starting to take Trabectedin the consumer reported adverse symptoms, such as: Oesophagitis UlcerativeThese side effects may potentially be related to Trabectedin.
Trabectedin Side Effect Report#7602895-7
Blood Creatinine Increased, Cardiac Failure Congestive, Diarrhoea, Pancytopenia, Asthenia, Cognitive Disorder
This is a report of a 72-year-old female patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: NA, who was treated with Trabectedin (dosage: Cycle 2 Total Dose 1.98mg, start time:
Oct 28, 2010), combined with:
  • Doxorubicin Hydrochloride
  • Dexamethasone
  • Granisetron
  • Dexamethasone (3 Days)
and developed a serious reaction and side effect(s): Blood Creatinine Increased, Cardiac Failure Congestive, Diarrhoea, Pancytopenia, Asthenia, Cognitive Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in female patients, resulting in Blood Creatinine Increased side effect. The patient was hospitalized.
Trabectedin Side Effect Report#7514609-X
Sciatica, Prothrombin Time Prolonged
This report suggests a potential Trabectedin Sciatica side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from Germany was diagnosed with the following symptoms/conditions: ovarian cancer recurrent and used Trabectedin (dosage: Four Courses) starting
Dec 09, 2010. After starting Trabectedin the patient began experiencing various side effects, including: Sciatica, Prothrombin Time ProlongedAdditional drugs used concurrently:
  • Doxorubicin Hydrochloride (Four Courses)
Although Trabectedin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sciatica, may still occur.
Trabectedin Side Effect Report#7499895-7
Memory Impairment, Cerebral Small Vessel Ischaemic Disease, Cerebral Atrophy, Confusional State
This Memory Impairment problem was reported by a physician from United Kingdom. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: leiomyosarcoma metastatic. On
Sep 23, 2010 this consumer started treatment with Trabectedin (dosage: 1.5 Mg/m2; Once; Iv). The following drugs were being taken at the same time: NA. When using Trabectedin, the patient experienced the following unwanted symptoms/side effects: Memory Impairment, Cerebral Small Vessel Ischaemic Disease, Cerebral Atrophy, Confusional StateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Memory Impairment, may become evident only after a product is in use by the general population.
Trabectedin Side Effect Report#7491601-5
Asthenia, Cardiac Failure Congestive, Cognitive Disorder, Blood Creatinine Increased, Pancytopenia, Diarrhoea
This Asthenia side effect was reported by a health professional from Spain. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Trabectedin (drug dosage: Cycle 2 Total Dose 1.98mg), which was initiated on
Oct 28, 2010. Concurrently used drugs: NA..After starting to take Trabectedin the consumer reported adverse symptoms, such as: Asthenia, Cardiac Failure Congestive, Cognitive Disorder, Blood Creatinine Increased, Pancytopenia, DiarrhoeaThese side effects may potentially be related to Trabectedin. The patient was hospitalized.
Trabectedin Side Effect Report#7399454-0
Neutropenia, Blood Creatine Phosphokinase Increased, Muscle Spasms
This is a report of a 45-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: liposarcoma, who was treated with Trabectedin (dosage: Iv; 2.45 Mg;iv; 2.45 Mg; Iv, start time:
Aug 23, 2010), combined with: NA. and developed a serious reaction and side effect(s): Neutropenia, Blood Creatine Phosphokinase Increased, Muscle Spasms after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Trabectedin treatment in female patients, resulting in Neutropenia side effect.


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The appearance of Trabectedin 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.

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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.

    Trabectedin 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 Trabectedin

    Side Effects reported to FDA: 50

    Trabectedin safety alerts: No

    Reported deaths: 22

    Reported hospitalizations: 31

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