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Vorinostat adverse events reported to FDA.

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Summary

FDA Adverse Reports: 22. View All

Vorinostat FDA safety alerts: No

Reported deaths: 2

Reported hospitalizations: 13

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Often additional risks of using a medication, such as Vorinostat, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Vorinostat users, Learn more about unwanted side effects & find ways to reduce them. Browse Vorinostat Adverse Reports reported to FDA and participate in Vorinostat discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Vorinostat. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Vorinostat Adverse Effect Reports (FDA)

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6836150-X | Chest Discomfort, Chest Pain, Dyspnoea
on Jul 12, 2010 Female patient from UNITED STATES , 60 years of age, weighting 200.0 lb, was diagnosed with leiomyosarcoma and was treated with Vorinostat (View Usage). Patient experienced the following unwanted or unexpected effects: chest discomfort, chest pain (What is chest pain?), dyspnoea. Vorinostat dosage: 400mg Po Qd. During the same period patient was treated with HYDROXYCHLOROQUINE SULFATE (400mg Po Qd) (View Hydroxychloroquine Sulfate Review and Hydroxychloroquine Sulfate Label ), ZESTORETIC (View Zestoretic Review and Zestoretic Label ), LANTUS (View Lantus Review and Lantus Label ), PROTONIX (View Protonix Review and Protonix Label ), HYDROMORPHONE (View Hydromorphone Review and Hydromorphone Label ). Patient was hospitalized.

6719672-1 | Lymphopenia
Patient was taking Vorinostat (View Usage). Patient had the following side effects: lymphopenia on May 10, 2010 from UNITED STATES Additional patient health information: Male patient , 54 years of age, weighting 147.0 lb, was diagnosed with non-small cell lung cancer and. Vorinostat dosage: 300mg Daily Oral. During the same period patient was treated with BORTEZOMIB (1.0mg/m2 Day 1, 4, 8, 11 Iv) (View Bortezomib Review and Bortezomib Label ), DULCOLAX (View Dulcolax Review and Dulcolax Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), OXYCONTIN (View Oxycontin Review and Oxycontin Label ), OXYCODONE (View Oxycodone Review and Oxycodone Label ).

6536982-1 | Atrial Flutter, Cardiac Failure, Chills, Decreased Activity, Diarrhoea, Dizziness, Dyspnoea, Ejection Fraction Decreased, Fatigue
Adverse event was reported on Dec 28, 2009 by a Male patient taking Vorinostat (View Usage) (Dosage: 400 Mg, Daily; Po) was diagnosed with multiple myeloma (What is multiple myeloma?) and. Location: UNITED STATES , 61 years of age, weighting 167.0 lb, After Vorinostat was administered, patient had the following side effects: atrial flutter, cardiac failure, chills, decreased activity, diarrhoea, dizziness (What is dizziness?), dyspnoea, ejection fraction decreased, fatigue. During the same period patient was treated with VELCADE (2.5 Mg/iv) (View Velcade Review and Velcade Label ), DOXIL (57 Mg; Iv) (View Doxil Review and Doxil Label ), AMBIEN (View Ambien Review and Ambien Label ), CRESTOR (View Crestor Review and Crestor Label ), VALTREX (View Valtrex Review and Valtrex Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), PYRIDOXINE (View Pyridoxine Review and Pyridoxine Label ).

6527964-4 | Blood Culture Positive, Device Related Sepsis, Haematuria, Haemoptysis, Refusal Of Treatment By Patient, Staphylococcal Sepsis
on Dec 21, 2009 Male patient from FRANCE , 65 years of age, was diagnosed with myelodysplastic syndrome and was treated with Vorinostat (View Usage). Patient experienced the following unwanted or unexpected effects: blood culture positive, device related sepsis, haematuria, haemoptysis, refusal of treatment by patient, staphylococcal sepsis. Vorinostat dosage: 400 Mg/daily, Po. Patient was hospitalized.


6450147-3 | Electrocardiogram Qt Prolonged
on Nov 20, 2009 Male patient from UNITED STATES , 49 years of age, weighting 110.0 lb, was diagnosed with neoplasm and was treated with Vorinostat (View Usage). Patient had the following side effects: electrocardiogram qt prolonged. Vorinostat dosage: 200 Mg Every Day Po.

6395551-7 | Subclavian Vein Thrombosis
Patient was taking Vorinostat (View Usage). After Vorinostat was administered, patient had the following side effects: subclavian vein thrombosis on Oct 02, 2009 from UNITED STATES Additional patient health information: Male patient , 62 years of age, weighting 196.2 lb, was diagnosed with oesophageal adenocarcinoma and. Vorinostat dosage: . During the same period patient was treated with FOLIC ACID (View Folic Acid Review and Folic Acid Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), CYANOCOBALAMIN (View Cyanocobalamin Review and Cyanocobalamin Label ), IRINOTECAN HYDROCHLORIDE (View Irinotecan Hydrochloride Review and Irinotecan Hydrochloride Label ), LEUCOVORIN CALCIUM (View Leucovorin Calcium Review and Leucovorin Calcium Label ), FLUOROURACIL (View Fluorouracil Review and Fluorouracil Label ).

6376072-4 | Asthenia, Blood Lactate Dehydrogenase Increased, Blood Urea Increased, Diastolic Dysfunction, Electrocardiogram St Segment Depression, Electrocardiogram T Wave Inversion, Haemoglobin Decreased, Hyperglycaemia, Nausea
Adverse event was reported on Sep 09, 2009 by a Male patient taking Vorinostat (View Usage) (Dosage: 400 Mg/daily Po) was diagnosed with mycosis fungoides and. Location: ITALY , 63 years of age, Patient experienced the following unwanted or unexpected effects: asthenia, blood lactate dehydrogenase increased, blood urea increased, diastolic dysfunction, electrocardiogram st segment depression, electrocardiogram t wave inversion, haemoglobin decreased, hyperglycaemia, nausea (What is nausea?). During the same period patient was treated with AMLODIPINE BESYLATE (View Amlodipine Besylate Review and Amlodipine Besylate Label ), CETIRIZINE HYDROCHLORIDE (View Cetirizine Hydrochloride Review and Cetirizine Hydrochloride Label ), FENOFIBRATE (View Fenofibrate Review and Fenofibrate Label ), GLICLAZIDE (View Gliclazide Review and Gliclazide Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), NEBIVOLOL (View Nebivolol Review and Nebivolol Label ). Patient was hospitalized.

6355607-1 | Anaemia, Gastric Cancer, Sepsis, Thrombocytopenia, White Blood Cell Count Decreased
on Aug 24, 2009 Male patient from FRANCE , 78 years of age, was diagnosed with myelodysplastic syndrome and was treated with Vorinostat (View Usage). Patient had the following side effects: anaemia, gastric cancer, sepsis (What is sepsis?), thrombocytopenia, white blood cell count decreased. Vorinostat dosage: 400 Mg/daily. During the same period patient was treated with CYTARABINE (20 Mg/daily) (View Cytarabine Review and Cytarabine Label ). Patient was hospitalized.

6220560-8 | Acute Myeloid Leukaemia, Disease Progression, Haematemesis, Hypokalaemia, Nausea, Platelet Count Decreased
on May 25, 2009 Male patient from UNITED STATES , 64 years of age, weighting 264.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Vorinostat (View Usage). After Vorinostat was administered, patient had the following side effects: acute myeloid leukaemia, disease progression, haematemesis, hypokalaemia, nausea (What is nausea?), platelet count decreased. Vorinostat dosage: 400 Mg/daily/po. During the same period patient was treated with INJ DECITABINE (48 Mg/daily/iv) (View Inj Decitabine Review and Inj Decitabine Label ), DIFLUCAN (View Diflucan Review and Diflucan Label ), EUCERIN CREME (View Eucerin Creme Review and Eucerin Creme Label ), EXJADE (View Exjade Review and Exjade Label ), HYDREA (View Hydrea Review and Hydrea Label ), IMODIUM (View Imodium Review and Imodium Label ), K DUR (View K-dur Review and K-dur Label ), LASIX (View Lasix Review and Lasix Label ). Patient was hospitalized and became disabled.

6129287-4 | Hepatic Enzyme Increased, Rash
Patient was taking Vorinostat (View Usage). Patient experienced the following unwanted or unexpected effects: hepatic enzyme increased, rash (What is rash?) on Mar 23, 2009 from UNITED STATES Additional patient health information: Male patient , 68 years of age, was diagnosed with mycosis fungoides and. Vorinostat dosage: 200 Mg Every Day Po.

6091462-5 | B-cell Lymphoma, Epstein-barr Virus Associated Lymphoproliferative Disorder
Adverse event was reported on Feb 19, 2009 by a Male patient taking Vorinostat (View Usage) (Dosage: 300 Mg Once Daily Oral) was diagnosed with hodgkin's disease refractory and. Location: UNITED STATES , 13 years of age, weighting 103.6 lb, Patient had the following side effects: b-cell lymphoma, epstein-barr virus associated lymphoproliferative disorder. During the same period patient was treated with ASPIRIN (View Aspirin Review and Aspirin Label ).

5998017-9 | Pericardial Effusion, Pleural Effusion
on Nov 28, 2008 Male patient from UNITED STATES , 71 years of age, weighting 116.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Vorinostat (View Usage). After Vorinostat was administered, patient had the following side effects: pericardial effusion, pleural effusion. Vorinostat dosage: 200 Mg/tid/po. During the same period patient was treated with ACTOS (View Actos Review and Actos Label ), GLUCOTROL (View Glucotrol Review and Glucotrol Label ), CYANOCOBALAMIN (View Cyanocobalamin Review and Cyanocobalamin Label ), VITAMIN E (View Vitamin E Review and Vitamin E Label ), VITAMINS (View Vitamins Review and Vitamins Label ). Patient was hospitalized.

5997295-X | Fall, Haemoglobin Decreased, Neuropathy Peripheral
on Nov 24, 2008 Female patient from UNITED STATES , 54 years of age, weighting 101.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Vorinostat (View Usage). Patient experienced the following unwanted or unexpected effects: fall (What is fall?), haemoglobin decreased, neuropathy peripheral. Vorinostat dosage: 200 Mg/tid/po. During the same period patient was treated with BENADRYL (View Benadryl Review and Benadryl Label ), COMPAZINE (View Compazine Review and Compazine Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), CEPHALEXIN (View Cephalexin Review and Cephalexin Label ), MAGNESIA (MILK OF) (View Magnesia (milk Of) Review and Magnesia (milk Of) Label ).

5957496-3 | No Therapeutic Response, Pneumonia Fungal, Stenotrophomonas Infection
Patient was taking Vorinostat (View Usage). Patient had the following side effects: no therapeutic response, pneumonia fungal, stenotrophomonas infection on Nov 05, 2008 from UNITED STATES Additional patient health information: Male patient , 61 years of age, weighting 235.0 lb, was diagnosed with acute myeloid leukaemia and. Vorinostat dosage: 400 Mg/daily/po. During the same period patient was treated with VICODIN (View Vicodin Review and Vicodin Label ), ZOFRAN (View Zofran Review and Zofran Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ). Patient was hospitalized.

5869283-5 | Asthenia, Bundle Branch Block Right, Hypophagia, Nausea, Syncope, Syncope Vasovagal, Urinary Tract Obstruction
Adverse event was reported on Aug 15, 2008 by a Female patient taking Vorinostat (View Usage) (Dosage: 400 Mg/daily/po) was diagnosed with acute myeloid leukaemia, myelodysplastic syndrome, rosacea (What is rosacea?), hyperlipidaemia and. Location: UNITED STATES , 71 years of age, weighting 152.0 lb, After Vorinostat was administered, patient had the following side effects: asthenia, bundle branch block right, hypophagia, nausea (What is nausea?), syncope, syncope vasovagal, urinary tract obstruction. During the same period patient was treated with DOXYCYCLINE (50 Mg/bid/po) (View Doxycycline Review and Doxycycline Label ), GEMFIBROZIL (600 Mg/bid/po) (View Gemfibrozil Review and Gemfibrozil Label ), DECITABINE (35 Mg/daily/iv) (View Decitabine Review and Decitabine Label ). Patient was hospitalized.

5809587-5 | Bone Metabolism Disorder, Condition Aggravated, Hypercalcaemia, Mycosis Fungoides, Renal Failure, Thrombocytopenia
on Jun 12, 2008 Female patient from GERMANY , 48 years of age, was diagnosed with mycosis fungoides and was treated with Vorinostat (View Usage). Patient experienced the following unwanted or unexpected effects: bone metabolism disorder, condition aggravated, hypercalcaemia, mycosis fungoides, renal failure, thrombocytopenia. Vorinostat dosage: 400 Mg/daily Po. Patient was hospitalized and became disabled.

5744666-2 | Asthenia, Bundle Branch Block Right, Electrocardiogram Qt Prolonged, Nausea, Oral Disorder, Syncope, Treatment Noncompliance
on Apr 30, 2008 Female patient from UNITED STATES , 71 years of age, weighting 152.0 lb, was diagnosed with acute myeloid leukaemia, rosacea (What is rosacea?), hyperlipidaemia, acute leukaemia, myelodysplastic syndrome, hypertension, antibiotic prophylaxis and was treated with Vorinostat (View Usage). Patient had the following side effects: asthenia, bundle branch block right, electrocardiogram qt prolonged, nausea (What is nausea?), oral disorder, syncope, treatment noncompliance. Vorinostat dosage: 400 Mg/daily/po. During the same period patient was treated with DOXYCYCLINE (50 Mg/daily/po) (View Doxycycline Review and Doxycycline Label ), GEMFIBROZIL (600 Mg/bid/po) (View Gemfibrozil Review and Gemfibrozil Label ), DECITABINE (35 Mg/daily/iv : 35 Mg/daily/iv) (View Decitabine Review and Decitabine Label ), BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (2.6 Mg/daily/po) (View Bisoprolol Fumarate And Hydrochlorothiazide Review and Bisoprolol Fumarate And Hydrochlorothiazide Label ), AVELOX (400 Mg/daily/po) (View Avelox Review and Avelox Label ). Patient was hospitalized.

5621663-9 | Asthenia, Diabetes Mellitus Inadequate Control, Disorientation, Dysuria, Fall, Loss Of Consciousness, Malignant Neoplasm Progression, Muscle Spasms, Muscular Weakness
Patient was taking Vorinostat (View Usage). After Vorinostat was administered, patient had the following side effects: asthenia, diabetes mellitus inadequate control, disorientation, dysuria, fall (What is fall?), loss of consciousness, malignant neoplasm progression, muscle spasms, muscular weakness on Jan 22, 2008 from UNITED STATES Additional patient health information: Male patient , 56 years of age, weighting 150.0 lb, was diagnosed with non-small cell lung cancer, anxiety (What is anxiety?) and. Vorinostat dosage: 200 Mg/bid/po. During the same period patient was treated with ERLOTINIB HYDROCHLORIDE (Po) (View Erlotinib Hydrochloride Review and Erlotinib Hydrochloride Label ), ATIVAN (1 Mg/tid) (View Ativan Review and Ativan Label ), ALTACE (View Altace Review and Altace Label ), CENTRUM SILVER (View Centrum Silver Review and Centrum Silver Label ), EXCEDRIN (ACETAMINOPHEN (+) CAFFEINE) (View Excedrin (acetaminophen (+) Caffeine) Review and Excedrin (acetaminophen (+) Caffeine) Label ), LOMOTIL (View Lomotil Review and Lomotil Label ), SOMA (View Soma Review and Soma Label ), ZYRTEC D (View Zyrtec-d Review and Zyrtec-d Label ). Patient was hospitalized and became disabled.

5483698-9 | Abdominal Pain, Caecitis, Cellulitis, Cheilitis, Febrile Neutropenia, Herpes Simplex, Oral Intake Reduced, Pyrexia, Weight Decreased
Adverse event was reported on Sep 26, 2007 by a Female patient taking Vorinostat (View Usage) (Dosage: 400 Mg/daily/po Cap) was diagnosed with acute myeloid leukaemia and. Location: UNITED STATES , 18 years of age, weighting 114.0 lb, Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), caecitis, cellulitis (What is cellulitis?), cheilitis, febrile neutropenia, herpes simplex (What is herpes simplex?), oral intake reduced, pyrexia, weight decreased. During the same period patient was treated with DECITABINE (20 Mg/m[2] /daily/iv) (View Decitabine Review and Decitabine Label ). Patient was hospitalized.

5378068-8 | Amnesia, Speech Disorder, Tremor
on Jun 22, 2007 Male patient from UNITED STATES , 67 years of age, weighting 92.00 lb, was diagnosed with multiple myeloma (What is multiple myeloma?) and was treated with Vorinostat (View Usage). Patient had the following side effects: amnesia, speech disorder, tremor. Vorinostat dosage: 400 Mg/daily/po. During the same period patient was treated with VELCADE (0.9mg/m[2]/daily/iv) (View Velcade Review and Velcade Label ), ACCUPRIL (View Accupril Review and Accupril Label ), ADVAIR DISKUS 100/50 (View Advair Diskus 100/50 Review and Advair Diskus 100/50 Label ), CARDIZEM (View Cardizem Review and Cardizem Label ), CENTRUM (View Centrum Review and Centrum Label ), COUMADIN (View Coumadin Review and Coumadin Label ), LORTAB (View Lortab Review and Lortab Label ), LOVENOX (View Lovenox Review and Lovenox Label ).

5378067-6 | Activities Of Daily Living Impaired, Neuropathy Peripheral
on Jun 22, 2007 Male patient from UNITED STATES , 55 years of age, weighting 231.0 lb, was diagnosed with multiple myeloma (What is multiple myeloma?) and was treated with Vorinostat (View Usage). After Vorinostat was administered, patient had the following side effects: activities of daily living impaired, neuropathy peripheral. Vorinostat dosage: 400 Mg/daily/po. During the same period patient was treated with VELCADE (1.9 Mg/daily/iv) (View Velcade Review and Velcade Label ), CENTRUM (View Centrum Review and Centrum Label ), FOSAMAX (View Fosamax Review and Fosamax Label ), VALTREX (View Valtrex Review and Valtrex Label ), VITAMIN B COMPLEX CAP (View Vitamin B Complex Cap Review and Vitamin B Complex Cap Label ).

5369959-2 | Ascites, Body Temperature Increased, Dehydration, Fatigue, Hypokalaemia, Obstruction Gastric, Oral Intake Reduced, Pleural Effusion, Vomiting
Patient was taking Vorinostat (View Usage). Patient experienced the following unwanted or unexpected effects: ascites, body temperature increased, dehydration, fatigue, hypokalaemia, obstruction gastric, oral intake reduced, pleural effusion, vomiting on Jun 12, 2007 from SINGAPORE Additional patient health information: Female patient , 51 years of age, was diagnosed with breast cancer metastatic and. Vorinostat dosage: 400 Mg/am/po. During the same period patient was treated with METOCLOPRAMIDE (View Metoclopramide Review and Metoclopramide Label ), MORPHINE (View Morphine Review and Morphine Label ), POTASSIUM CHLORIDE (View Potassium Chloride Review and Potassium Chloride Label ), SODIUM CHLORIDE (View Sodium Chloride Review and Sodium Chloride Label ), TOLBUTAMIDE (View Tolbutamide Review and Tolbutamide Label ). Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Vorinostat risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Vorinostat quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Vorinostat use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Vorinostat Reactions
Abdominal PainWhat is Abdominal pain?
Activities Of Daily Living Impaired
Acute Myeloid Leukaemia
Amnesia
Anaemia
Ascites
Asthenia
Atrial Flutter
B-cell Lymphoma
Blood Culture Positive
Blood Lactate Dehydrogenase Increased
Blood Urea Increased
Body Temperature Increased
Bone Metabolism Disorder
Bundle Branch Block Right
Caecitis
Cardiac Failure
Dyspnoea
Electrocardiogram Qt Prolonged
FallWhat is Fall?
Fatigue
Haemoglobin Decreased
Hypokalaemia
NauseaWhat is Nausea?
Neuropathy Peripheral
Oral Intake Reduced
Pleural Effusion
Syncope
Thrombocytopenia
Vomiting
Vorinostat Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Vorinostat adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!