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Temsirolimus Side Effects

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Common Temsirolimus Side Effects


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

Disease Progression (85)
Pneumonia (67)
Dyspnoea (67)
Diarrhoea (62)
Pyrexia (61)
Dehydration (59)
Anaemia (52)
Death (47)
Vomiting (45)
Fatigue (43)
Renal Cell Carcinoma (41)
Febrile Neutropenia (40)
Nausea (40)
Interstitial Lung Disease (40)
Pleural Effusion (37)
Sepsis (35)
Deep Vein Thrombosis (32)
Hyperglycaemia (32)
Pneumonitis (30)
Haemoglobin Decreased (28)

➢ 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.

Temsirolimus Side Effects Reported to FDA



Temsirolimus Side Effect Report#9926043
Disease Progression, Metastatic Renal Cell Carcinoma
This is a report of a 76-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: metastatic renal cell carcinoma, who was treated with Temsirolimus (dosage: 25 Mg, Weekly, start time:
Jan 05, 2012), combined with: NA. and developed a serious reaction and side effect(s): Disease Progression, Metastatic Renal Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in male patients, resulting in Disease Progression side effect.
Temsirolimus Side Effect Report#9922447
Diabetes Mellitus, Transaminases Increased, Dyslipidaemia
This report suggests a potential Temsirolimus Diabetes Mellitus side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: renal cell carcinoma and used Temsirolimus (dosage: 25 Mg, Weekly) starting NS. After starting Temsirolimus the patient began experiencing various side effects, including: Diabetes Mellitus, Transaminases Increased, DyslipidaemiaAdditional drugs used concurrently: NA. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diabetes Mellitus, may still occur.
Temsirolimus Side Effect Report#9854059
Osteonecrosis Of Jaw
This Osteonecrosis Of Jaw problem was reported by a health professional from BR. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal cell carcinoma. On NS this consumer started treatment with Temsirolimus (dosage: 25 Mg, Weekly). The following drugs were being taken at the same time:
  • Bevacizumab (10 Mg/kg, Every 2 Weeks)
  • Captopril (25 Mg, 2x/day)
  • Hydrochlorothiazide (25 Mg, 1x/day)
When using Temsirolimus, the patient experienced the following unwanted symptoms/side effects: Osteonecrosis Of JawAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteonecrosis Of Jaw, may become evident only after a product is in use by the general population.
Temsirolimus Side Effect Report#9849413
Mycobacterial Infection, Hyperglycaemia
This Mycobacterial Infection side effect was reported by a health professional from CZ. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: metastatic renal cell carcinoma.The patient was prescribed Temsirolimus (drug dosage: 25 Mg, Weekly), which was initiated on NS. Concurrently used drugs: NA..After starting to take Temsirolimus the consumer reported adverse symptoms, such as: Mycobacterial Infection, HyperglycaemiaThese side effects may potentially be related to Temsirolimus.
Temsirolimus Side Effect Report#9832967
Erythema, Dyspnoea
This is a report of a 67-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: non-small cell lung cancer, who was treated with Temsirolimus (dosage: 8 Mg, Weekly, start time: 201109), combined with:
  • Neratinib (240 Mg, Daily)
  • Neratinib (160 Mg, Daily)
  • Loperamide (Unk)
  • Tiorfan (Unk)
  • Ivabradine Hydrochloride (Unk)
  • Paracetamol With Codeine (Unk)
  • Fraxodi (Unk)
and developed a serious reaction and side effect(s): Erythema, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in female patients, resulting in Erythema side effect.
Temsirolimus Side Effect Report#9771450
Dehydration
This report suggests a potential Temsirolimus Dehydration side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: non-small cell lung cancer and used Temsirolimus (dosage: 8 Mg, Weekly) starting
Jul 12, 2013. After starting Temsirolimus the patient began experiencing various side effects, including: DehydrationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Temsirolimus Side Effect Report#9771448
Hyponatraemia, Hypokalaemia, Nausea, Diarrhoea
This Hyponatraemia problem was reported by a physician from US. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Sep 24, 2013 this consumer started treatment with Temsirolimus (dosage: 8 Mg, Weekly). The following drugs were being taken at the same time:
  • Neratinib (240 Mg, Daily)
  • Docusate (Unk)
  • Senna (Unk)
  • Miralax (Unk)
  • Lorazepam (Unk)
  • Nasal Saline (Unk)
  • Benzonatate (Unk)
  • Guaifenesin W/dextromethorphan (Unk)
When using Temsirolimus, the patient experienced the following unwanted symptoms/side effects: Hyponatraemia, Hypokalaemia, Nausea, DiarrhoeaThe 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 Hyponatraemia, may become evident only after a product is in use by the general population.
Temsirolimus Side Effect Report#9702006
Bronchopneumonia
This Bronchopneumonia side effect was reported by a physician from ES. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal cell carcinoma,prostate cancer.The patient was prescribed Temsirolimus (drug dosage: 10 Mg/ml, Weekly), which was initiated on
Aug 19, 2010. Concurrently used drugs:
  • Zoladex (Unk)
  • Casodex (Unk)
  • Carvedilol (Unk)
  • Captopril (Unk)
  • Lovastatin (Unk)
.After starting to take Temsirolimus the consumer reported adverse symptoms, such as: BronchopneumoniaThese side effects may potentially be related to Temsirolimus. The patient was hospitalized.
Temsirolimus Side Effect Report#9669863
Disease Progression, Renal Cell Carcinoma
This is a report of a 62-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: renal cell carcinoma,prophylaxis,cancer pain,constipation, who was treated with Temsirolimus (dosage: 25 Mg, Weekly, start time:
Feb 14, 2011), combined with:
  • Polaramine (2 Mg, Weekly)
  • Fentos (4 Mg, 1x/day)
  • Maglax (660 Mg, 3x/day)
  • Lansoprazole Od (30 Mg, 1x/day)
  • Gasmotin (5 Mg, 3x/day)
  • Loxoprofen Sodium (1 Df, 3x/day)
  • Rebamipide (1 Df, 3x/day)
  • Depas (0.5 Mg, 1x/day)
and developed a serious reaction and side effect(s): Disease Progression, Renal Cell Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in female patients, resulting in Disease Progression side effect.
Temsirolimus Side Effect Report#9642217
Acute Respiratory Distress Syndrome, Pneumonia Staphylococcal
This report suggests a potential Temsirolimus Acute Respiratory Distress Syndrome side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: renal cell carcinoma,prophylaxis and used Temsirolimus (dosage: 25 Mg, Weekly) starting
Dec 15, 2011. After starting Temsirolimus the patient began experiencing various side effects, including: Acute Respiratory Distress Syndrome, Pneumonia StaphylococcalAdditional drugs used concurrently:
  • Restamin (60 Mg, 1x/day (on Temsirolimus Administration Day))
  • Fentos (1 Mg, 2x/day)
  • Opso (5 Mg, As Needed)
  • Loxonin (120 Mg, 2x/day)
  • Osteluc (400 Mg, 2x/day)
  • Antobron (15 Mg, 3x/day)
  • Eticalm (1.0 Mg, 1x/day)
  • Amoban (7.5 Mg, 1x/day)
The patient was hospitalized. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Respiratory Distress Syndrome, may still occur.
Temsirolimus Side Effect Report#9632200
Back Pain, Pancreatitis
This Back Pain problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: renal cell carcinoma. On 201301 this consumer started treatment with Temsirolimus (dosage: NA). The following drugs were being taken at the same time: NA. When using Temsirolimus, the patient experienced the following unwanted symptoms/side effects: Back Pain, PancreatitisThe 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 Back Pain, may become evident only after a product is in use by the general population.
Temsirolimus Side Effect Report#9627998
Vena Cava Thrombosis, Jugular Vein Thrombosis
This Vena Cava Thrombosis side effect was reported by a physician from DE. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Temsirolimus (drug dosage: 25 Mg, Cyclic (on Day 1 And Day 8)), which was initiated on
Sep 13, 2013. Concurrently used drugs:
  • Cisplatin (170 Mg, Unk)
  • Rituximab (637.5 Mg, Unk)
  • Dexamethasone (40 Mg, Unk)
  • Cytarabine (6900 Mg, 2x/day)
  • Metformin (1000 Mg, Daily)
  • Januvia (50 Mg, Unk)
  • Simvastatin (20 Mg, Daily)
  • Pantozol (40 Mg, Daily)
.After starting to take Temsirolimus the consumer reported adverse symptoms, such as: Vena Cava Thrombosis, Jugular Vein ThrombosisThese side effects may potentially be related to Temsirolimus. The patient was hospitalized.
Temsirolimus Side Effect Report#9617707
Opportunistic Infection, Muscle Haemorrhage
This is a report of a 62-year-old male patient (weight: NA) from GR, suffering from the following health symptoms/conditions: pancreatic carcinoma metastatic, who was treated with Temsirolimus (dosage: 25 Mg, Weekly, start time:
Aug 01, 2013), combined with:
  • Gemzar (2000 Mg (1000mg/m2), Cyclic (every Two Weeks))
  • Norvasc (5 Mg, 1x/day)
  • Zofron
  • Zantac
  • Fenistil
  • Dexamethasone
  • Sotalol (40 Mg, 2x/day)
  • Salospir (100 Mg, 1x/day)
and developed a serious reaction and side effect(s): Opportunistic Infection, Muscle Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in male patients, resulting in Opportunistic Infection side effect. The patient was hospitalized.
Temsirolimus Side Effect Report#9611217
Pneumocystis Jirovecii Infection
This report suggests a potential Temsirolimus Pneumocystis Jirovecii Infection side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from GR was diagnosed with the following symptoms/conditions: pancreatic carcinoma metastatic and used Temsirolimus (dosage: 25 Mg, Weekly) starting
Jul 11, 2013. After starting Temsirolimus the patient began experiencing various side effects, including: Pneumocystis Jirovecii InfectionAdditional drugs used concurrently:
  • Gemzar (1850 Mg, Cyclic (every Two Weeks))
  • Zofron
  • Zantac
  • Fenistil
  • Dexamethasone
  • Sotalol (160 Mg, 1/2x2)
  • Pantoprazole (40 Mg, 1x/day)
  • Pantoprazole
The patient was hospitalized. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumocystis Jirovecii Infection, may still occur.
Temsirolimus Side Effect Report#9610920
Neutropenic Sepsis
This Neutropenic Sepsis problem was reported by a physician from GB. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 13, 2013 this consumer started treatment with Temsirolimus (dosage: 10 Mg, Unk). The following drugs were being taken at the same time:
  • Gemcitabine Hydrochloride (1700 Mg, 2x/day)
  • Cisplatin (154 Mg, Unk)
When using Temsirolimus, the patient experienced the following unwanted symptoms/side effects: 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 Neutropenic Sepsis, may become evident only after a product is in use by the general population.
Temsirolimus Side Effect Report#9597021
Respiratory Failure, Sepsis, Renal Failure Acute
This Respiratory Failure side effect was reported by a physician from DE. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Temsirolimus (drug dosage: 50 Mg, Unk), which was initiated on
Apr 26, 2013. Concurrently used drugs:
  • Bendamustine (179 Mg, Unk)
  • Rituximab (745 Mg, Unk)
.After starting to take Temsirolimus the consumer reported adverse symptoms, such as: Respiratory Failure, Sepsis, Renal Failure AcuteThese side effects may potentially be related to Temsirolimus. The patient was hospitalized.
Temsirolimus Side Effect Report#9595335
Renal Tubular Necrosis
This is a report of a 73-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: mantle cell lymphoma, who was treated with Temsirolimus (dosage: Unk, start time: 201008), combined with:
  • Rituximab (Unk)
  • Dexamethasone (Unk)
  • Oxaliplatin (Unk)
  • Citarabin (Unk)
and developed a serious reaction and side effect(s): Renal Tubular Necrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in male patients, resulting in Renal Tubular Necrosis side effect. The patient was hospitalized.
Temsirolimus Side Effect Report#9566587
Cardiac Failure
This report suggests a potential Temsirolimus Cardiac Failure side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: acute myeloid leukaemia and used Temsirolimus (dosage: 12.5 Mg, Cyclic (induction I)) starting
Sep 17, 2013. After starting Temsirolimus the patient began experiencing various side effects, including: Cardiac FailureAdditional drugs used concurrently:
  • Daunorubicin Hcl (116.4 Mg, Daily)
  • Cytarabine (194 Mg, Daily)
  • Aciclovir (400 Mg, 3x/day)
  • Hydrochlorothiazide/irbesartan Hydrochloride (12.5mg/150mg, Daily)
  • Trimethoprim Comp.-ratiopharm (80 Mg Trimethoprim /10 Mg Sulfamethoxazole On Monday And Thursday)
  • Tamsulosin (0.4 Mg, Daily)
  • Torasemide (10 Mg, Daily)
  • Colistin (Unk)
Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure, may still occur.
Temsirolimus Side Effect Report#9540539
Febrile Neutropenia
This Febrile Neutropenia problem was reported by a physician from GB. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: transitional cell carcinoma. On
Jul 18, 2013 this consumer started treatment with Temsirolimus (dosage: 10 Mg, Unk). The following drugs were being taken at the same time:
  • Cisplatin (154 Mg, Unk)
  • Gemcitabine Hydrochloride (2200 Mg, Unk)
  • Calendula Cream (1 G, Daily)
  • Bonjela Complete Plus (1 Gtt, Daily)
  • Laxido (1 Df (sachet), Daily)
  • Cyclizine Hydrochloride (50 Mg, Daily)
  • Flucloxacillin (500 Mg, 4x/day)
  • Metoclopramide (10 Mg, Daily)
When using Temsirolimus, the patient experienced the following unwanted symptoms/side effects: Febrile NeutropeniaThe 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 Febrile Neutropenia, may become evident only after a product is in use by the general population.
Temsirolimus Side Effect Report#9513905
Febrile Neutropenia
This Febrile Neutropenia side effect was reported by a physician from ES. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: hormone-refractory prostate cancer.The patient was prescribed Temsirolimus (drug dosage: 15 Mg, Cyclic (day 1 And Day 16/21 Days)), which was initiated on
Aug 21, 2013. Concurrently used drugs:
  • Docetaxel (50 Mg/m2, Cyclic (21 Days))
.After starting to take Temsirolimus the consumer reported adverse symptoms, such as: Febrile NeutropeniaThese side effects may potentially be related to Temsirolimus. The patient was hospitalized.
Temsirolimus Side Effect Report#9504452
Disease Progression, Mantle Cell Lymphoma
This is a report of a 78-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: mantle cell lymphoma, who was treated with Temsirolimus (dosage: 75 Mg, Weekly (loading Dose And Maintenance Dose), start time:
Dec 07, 2012), combined with: NA. and developed a serious reaction and side effect(s): Disease Progression, Mantle Cell Lymphoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in male patients, resulting in Disease Progression side effect.
Temsirolimus Side Effect Report#9498746
Pyrexia
This report suggests a potential Temsirolimus Pyrexia side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Temsirolimus (dosage: 25 Mg, 1x/day) starting
Oct 10, 2012. After starting Temsirolimus the patient began experiencing various side effects, including: PyrexiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pyrexia, may still occur.
Temsirolimus Side Effect Report#9498345
Interstitial Lung Disease, Pneumocystis Jirovecii Pneumonia
This Interstitial Lung Disease problem was reported by a physician from JP. A 48-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: metastatic renal cell carcinoma. On
Jan 27, 2012 this consumer started treatment with Temsirolimus (dosage: 25 Mg, Weekly). The following drugs were being taken at the same time: NA. When using Temsirolimus, the patient experienced the following unwanted symptoms/side effects: Interstitial Lung Disease, Pneumocystis Jirovecii PneumoniaThe 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 Interstitial Lung Disease, may become evident only after a product is in use by the general population.
Temsirolimus Side Effect Report#9445060
Atypical Pneumonia
This Atypical Pneumonia side effect was reported by a physician from DE. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Temsirolimus (drug dosage: 50 Mg, Unk), which was initiated on
May 28, 2013. Concurrently used drugs:
  • Rituximab (618.75 Mg, Unk)
  • Bendamustine (148.50 Mg, Unk)
.After starting to take Temsirolimus the consumer reported adverse symptoms, such as: Atypical PneumoniaThese side effects may potentially be related to Temsirolimus. The patient was hospitalized.
Temsirolimus Side Effect Report#9425296
Gastric Antral Vascular Ectasia, Mucosal Haemorrhage
This is a report of a 40-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: renal cell carcinoma, who was treated with Temsirolimus (dosage: 15 Mg, 1x/day, start time: 201206), combined with: NA. and developed a serious reaction and side effect(s): Gastric Antral Vascular Ectasia, Mucosal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in female patients, resulting in Gastric Antral Vascular Ectasia side effect. The patient was hospitalized.


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The appearance of Temsirolimus 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 Temsirolimus Side Effects for Women?

Women Side EffectsReports
Dyspnoea 23
Disease Progression 21
Deep Vein Thrombosis 20
Diarrhoea 16
Vomiting 16
Nausea 15
Pleural Effusion 15
Death 14
Dehydration 14
Hyperglycaemia 14

What are common Temsirolimus Side Effects for Men?

Men Side EffectsReports
Disease Progression 63
Pneumonia 50
Pyrexia 50
Diarrhoea 46
Dehydration 45
Dyspnoea 44
Anaemia 39
Interstitial Lung Disease 38
Fatigue 34
Death 33

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    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.

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    Temsirolimus reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
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    More About Temsirolimus

    Side Effects reported to FDA: 1225

    Temsirolimus safety alerts: No

    Reported deaths: 288

    Reported hospitalizations: 904

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