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Zolinza Side Effects

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Common Zolinza Side Effects


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

Platelet Count Decreased (50)
Nausea (39)
Dehydration (33)
Diarrhoea (30)
Anaemia (28)
Fatigue (24)
Mycosis Fungoides (20)
Decreased Appetite (19)
Thrombocytopenia (18)
Death (17)
Renal Impairment (16)
Pyrexia (16)
Vomiting (15)
Pneumonia (14)
Dizziness (14)
Anorexia (14)
Disease Progression (13)
Dysgeusia (13)
Malaise (13)
Weight Decreased (13)

➢ 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.

Zolinza Side Effects Reported to FDA



Zolinza Side Effect Report#9857864
Electrolyte Imbalance, Nausea, Vomiting, Neutrophil Count Decreased, Platelet Count Decreased, Hepatitis C, Chronic Obstructive Pulmonary Disease, Asthma, Female Sterilisation
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: non-small cell lung cancer, who was treated with Zolinza (dosage: 100 Mg,q M-w-f, start time: 201311), combined with:
  • Carboplatin (Auc 5, Q 3 Weeks)
  • Pemetrexed Disodium (500 Mg/m2, Q 3 Weeks)
  • Ambien (10 Mg, Qhs)
  • Duragesic (25 Mcg/hr, Q3d)
  • Zofran (8 Mg, Q8h Prn)
  • Folic Acid (1 Mg, Qd)
  • Compazine (10 Mg, Q6h Prn)
  • Oxycodone (5 Mg, Q4h Prn)
and developed a serious reaction and side effect(s): Electrolyte Imbalance, Nausea, Vomiting, Neutrophil Count Decreased, Platelet Count Decreased, Hepatitis C, Chronic Obstructive Pulmonary Disease, Asthma, Female Sterilisation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza treatment in female patients, resulting in Electrolyte Imbalance side effect. The patient was hospitalized.
Zolinza Side Effect Report#9853527
Disease Progression
This report suggests a potential Zolinza Disease Progression side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Zolinza (dosage: Unk) starting 2013. After starting Zolinza the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Zolinza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Zolinza Side Effect Report#9853129
Renal Impairment
This Renal Impairment problem was reported by a consumer or non-health professional from US. A 75-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: lymphoma. On
Oct 12, 2013 this consumer started treatment with Zolinza (dosage: NA). The following drugs were being taken at the same time: NA. When using Zolinza, the patient experienced the following unwanted symptoms/side effects: Renal ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Impairment, may become evident only after a product is in use by the general population.
Zolinza Side Effect Report#9851403
Staphylococcal Bacteraemia
This Staphylococcal Bacteraemia side effect was reported by a consumer or non-health professional from US. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: t-cell lymphoma.The patient was prescribed Zolinza (drug dosage: 400 Mg, Qd), which was initiated on
Jun 18, 2013. Concurrently used drugs:
  • Aspirin (Unk)
  • Cholecalciferol (Unk)
  • Lipitor (Unk)
  • Proscar (Unk)
  • Triamcinolone (Unk)
.After starting to take Zolinza the consumer reported adverse symptoms, such as: Staphylococcal BacteraemiaThese side effects may potentially be related to Zolinza. The patient was hospitalized.
Zolinza Side Effect Report#9800697
Headache, Weight Increased, Hot Flush
This is a report of a 56-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: leukaemia, who was treated with Zolinza (dosage: 100 Mg, Qid, start time: 201304), combined with:
  • Hydrocodone (Unk)
  • Bc Powder (aspirin (+) Caffeine) (Unk)
and developed a serious reaction and side effect(s): Headache, Weight Increased, Hot Flush after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza treatment in female patients, resulting in Headache side effect.
Zolinza Side Effect Report#9784946
Embolism
This report suggests a potential Zolinza Capsules 100mg Embolism side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: mycosis fungoides and used Zolinza Capsules 100mg (dosage: 400 Mg, Qd) starting 201202. After starting Zolinza Capsules 100mg the patient began experiencing various side effects, including: EmbolismAdditional drugs used concurrently:
  • Predonine (10 Mg, Qd)
The patient was hospitalized. Although Zolinza Capsules 100mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Embolism, may still occur.
Zolinza Side Effect Report#9773066
Pleural Effusion, Leukocytosis, Breath Sounds Abnormal, Obstructive Airways Disorder, Chills, Pyrexia, Headache
This Pleural Effusion problem was reported by a physician from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer metastatic. On
Oct 31, 2013 this consumer started treatment with Zolinza (dosage: 100 Mg, Qd). The following drugs were being taken at the same time:
  • Arimidex (Unk)
When using Zolinza, the patient experienced the following unwanted symptoms/side effects: Pleural Effusion, Leukocytosis, Breath Sounds Abnormal, Obstructive Airways Disorder, Chills, Pyrexia, HeadacheThe 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.
Zolinza Side Effect Report#9771425
Fibrin Degradation Products Increased, Fibrin D Dimer Increased, Deep Vein Thrombosis, Decreased Appetite, Platelet Count Decreased, Drowning
This Fibrin Degradation Products Increased side effect was reported by a consumer or non-health professional from JP. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: mycosis fungoides.The patient was prescribed Zolinza Capsules 100mg (drug dosage: 300 Mg, Qd), which was initiated on
Dec 28, 2010. Concurrently used drugs: NA..After starting to take Zolinza Capsules 100mg the consumer reported adverse symptoms, such as: Fibrin Degradation Products Increased, Fibrin D Dimer Increased, Deep Vein Thrombosis, Decreased Appetite, Platelet Count Decreased, DrowningThese side effects may potentially be related to Zolinza Capsules 100mg. The patient was hospitalized.
Zolinza Side Effect Report#9768325
Haemolytic Anaemia, Platelet Count Decreased, Anaemia
This is a report of a 68-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: mycosis fungoides, who was treated with Zolinza Capsules 100mg (dosage: 400 Mg, Qd, start time:
Dec 03, 2011), combined with: NA. and developed a serious reaction and side effect(s): Haemolytic Anaemia, Platelet Count Decreased, Anaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza Capsules 100mg treatment in male patients, resulting in Haemolytic Anaemia side effect.
Zolinza Side Effect Report#9701616
Mycosis Fungoides, C-reactive Protein Increased, Platelet Count Decreased, Platelet Count Decreased, Platelet Count Decreased
This report suggests a potential Zolinza Capsules 100mg Mycosis Fungoides side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: mycosis fungoides and used Zolinza Capsules 100mg (dosage: 400 Mg, Qd) starting
Apr 11, 2012. After starting Zolinza Capsules 100mg the patient began experiencing various side effects, including: Mycosis Fungoides, C-reactive Protein Increased, Platelet Count Decreased, Platelet Count Decreased, Platelet Count DecreasedAdditional drugs used concurrently: NA. Although Zolinza Capsules 100mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mycosis Fungoides, may still occur.
Zolinza Side Effect Report#9681203
Hepatocellular Carcinoma, Renal Failure Chronic, Malaise, Hepatic Function Abnormal, Hepatic Function Abnormal
This Hepatocellular Carcinoma problem was reported by a consumer or non-health professional from JP. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: anaplastic large cell lymphoma t- and null-cell types. On
Jan 04, 2012 this consumer started treatment with Zolinza Capsules 100mg (dosage: 100 Mg, Qd). The following drugs were being taken at the same time:
  • Nidran
  • Beselna
  • Nu-lotan Tablet 50 (50 Mg, Qd)
  • Losartan Potassium (50 Mg, Qd)
  • Coniel (8 Mg, Qd)
  • Zetia Tablets 10mg (10 Mg, Qd)
  • Mevan (10 Mg, Qd)
  • Magnesium Oxide (Formulation : Fgr, 1.0 G, Qd)
When using Zolinza Capsules 100mg, the patient experienced the following unwanted symptoms/side effects: Hepatocellular Carcinoma, Renal Failure Chronic, Malaise, Hepatic Function Abnormal, Hepatic Function AbnormalThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatocellular Carcinoma, may become evident only after a product is in use by the general population.
Zolinza Side Effect Report#9607263
Adult T-cell Lymphoma/leukaemia, Platelet Count Decreased, Jaundice, Blood Lactate Dehydrogenase Increased, Blood Creatinine Increased
This Adult T-cell Lymphoma/leukaemia side effect was reported by a consumer or non-health professional from JP. A 62-year-old male patient (weight:NA) experienced the following symptoms/conditions: adult t-cell lymphoma/leukaemia.The patient was prescribed Zolinza Capsules 100mg (drug dosage: 400 Mg, Qd), which was initiated on
Oct 12, 2011. Concurrently used drugs: NA..After starting to take Zolinza Capsules 100mg the consumer reported adverse symptoms, such as: Adult T-cell Lymphoma/leukaemia, Platelet Count Decreased, Jaundice, Blood Lactate Dehydrogenase Increased, Blood Creatinine IncreasedThese side effects may potentially be related to Zolinza Capsules 100mg. The patient was hospitalized.
Zolinza Side Effect Report#9564143
Hepatic Function Abnormal, Hepatic Encephalopathy
This is a report of a 43-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breast cancer metastatic, who was treated with Zolinza (dosage: 400 Mg, Qd, start time:
Sep 12, 2013), combined with:
  • Proventil (90 Mcq/inh)
  • Atenolol (25 Mg, Qdl)
  • Lorazepam (0.5 Mg, Bid)
  • Zolpidem Tartrate (10 Mg, Qpm)
  • Oxycodone (10 Mg, Q4h)
  • Scopolamine
  • Claritin (10 Mg, Qd)
  • Letrozole (2.5 Mg, Qd)
and developed a serious reaction and side effect(s): Hepatic Function Abnormal, Hepatic Encephalopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza treatment in female patients, resulting in Hepatic Function Abnormal side effect. The patient was hospitalized.
Zolinza Side Effect Report#9541339
Cellulitis, Treatment Noncompliance
This report suggests a potential Zolinza Cellulitis side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: t-cell lymphoma,hypertension,routine health maintenance,pruritus and used Zolinza (dosage: 400 Mg, Qd) starting 201207. After starting Zolinza the patient began experiencing various side effects, including: Cellulitis, Treatment NoncomplianceAdditional drugs used concurrently:
  • Clonidine (Unk)
  • Omega-3 Marine Triglycerides (Unk)
  • Hydroxyzine (Unk)
  • Losartan Potassium And Hydrochlorothiazide Tablets (Unk)
  • Metoprolol (Unk)
  • Synthroid (Unk)
  • Triamcinolone (Unk)
  • Tribenzor (Unk)
The patient was hospitalized. Although Zolinza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cellulitis, may still occur.
Zolinza Side Effect Report#9538988
Febrile Neutropenia
This Febrile Neutropenia problem was reported by a health professional from FR. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: mycosis fungoides. On
Jan 27, 2013 this consumer started treatment with Zolinza (dosage: 4 Df, Qd). The following drugs were being taken at the same time: NA. When using Zolinza, the patient experienced the following unwanted symptoms/side effects: Febrile NeutropeniaAlthough 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.
Zolinza Side Effect Report#9538871
Renal Failure Acute
This Renal Failure Acute side effect was reported by a health professional from FR. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: mycosis fungoides.The patient was prescribed Zolinza (drug dosage: 4 Df, Qd), which was initiated on
Jan 27, 2013. Concurrently used drugs: NA..After starting to take Zolinza the consumer reported adverse symptoms, such as: Renal Failure AcuteThese side effects may potentially be related to Zolinza. The patient was hospitalized.
Zolinza Side Effect Report#9536626
Myasthenic Syndrome
This is a report of a 79-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: mycosis fungoides, who was treated with Zolinza (dosage: 100 Mg, Bid, start time: 201307), combined with:
  • Levothyrox
  • Inexium
  • Lyrica
  • Paroxetine
  • Seresta
  • Amlor
  • Atarax (hydroxyzine Hydrochloride)
  • Cetirizine Hydrochloride
and developed a serious reaction and side effect(s): Myasthenic Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza treatment in female patients, resulting in Myasthenic Syndrome side effect.
Zolinza Side Effect Report#9506956
Small Intestinal Obstruction
This report suggests a potential Zolinza Small Intestinal Obstruction side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Zolinza (dosage: 100 Mg, Bid) starting 201305. After starting Zolinza the patient began experiencing various side effects, including: Small Intestinal ObstructionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Zolinza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Small Intestinal Obstruction, may still occur.
Zolinza Side Effect Report#9474912
This Death problem was reported by a pharmacist from US. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: leukaemia. On
Jul 12, 2013 this consumer started treatment with Zolinza (dosage: NA). The following drugs were being taken at the same time: NA. When using Zolinza, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Zolinza Side Effect Report#9447204
Pancytopenia, Disseminated Intravascular Coagulation, Sepsis, Platelet Count Decreased, White Blood Cell Count Decreased, Anaemia, Pneumonia, Dermatitis Exfoliative, Skin Exfoliation
This Pancytopenia side effect was reported by a consumer or non-health professional from JP. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: mycosis fungoides,infection.The patient was prescribed Zolinza Capsules 100mg (drug dosage: 400 Mg, Qd), which was initiated on
Mar 22, 2013. Concurrently used drugs:
  • Dermovate
  • Nerisona
  • Locoid
.After starting to take Zolinza Capsules 100mg the consumer reported adverse symptoms, such as: Pancytopenia, Disseminated Intravascular Coagulation, Sepsis, Platelet Count Decreased, White Blood Cell Count Decreased, Anaemia, Pneumonia, Dermatitis Exfoliative, Skin ExfoliationThese side effects may potentially be related to Zolinza Capsules 100mg. The patient was hospitalized.
Zolinza Side Effect Report#9441747
Thrombophlebitis, Renal Impairment, Platelet Count Decreased
This is a report of a 61-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: mycosis fungoides, who was treated with Zolinza Capsules 100mg (dosage: 400 Mg, Qd, start time:
Oct 09, 2012), combined with: NA. and developed a serious reaction and side effect(s): Thrombophlebitis, Renal Impairment, Platelet Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza Capsules 100mg treatment in female patients, resulting in Thrombophlebitis side effect. The patient was hospitalized.
Zolinza Side Effect Report#9441592
Disease Progression
This report suggests a potential Zolinza Disease Progression side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: adult t-cell lymphoma/leukaemia and used Zolinza (dosage: 100 Mg, Qid) starting
Jun 26, 2013. After starting Zolinza the patient began experiencing various side effects, including: Disease ProgressionAdditional drugs used concurrently: NA. Although Zolinza demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Progression, may still occur.
Zolinza Side Effect Report#9433493
Renal Disorder, Platelet Count Decreased, C-reactive Protein Increased, Platelet Count Decreased, Renal Disorder
This Renal Disorder problem was reported by a consumer or non-health professional from JP. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: mycosis fungoides. On
May 17, 2013 this consumer started treatment with Zolinza Capsules 100mg (dosage: 300 Mg, Qd). The following drugs were being taken at the same time: NA. When using Zolinza Capsules 100mg, the patient experienced the following unwanted symptoms/side effects: Renal Disorder, Platelet Count Decreased, C-reactive Protein Increased, Platelet Count Decreased, Renal DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Disorder, may become evident only after a product is in use by the general population.
Zolinza Side Effect Report#9432037
Cardiac Failure Congestive
This Cardiac Failure Congestive side effect was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: acute myeloid leukaemia.The patient was prescribed Zolinza (drug dosage: 400 Mg, Qd), which was initiated on
Sep 10, 2012. Concurrently used drugs:
  • Mylotarg (5 Mg, Unk)
  • Mylotarg (5 Mg, Unk)
  • Vidaza (125 Mg, Unk)
  • Furosemide (Unk)
  • Oxygen (Unk)
  • Ambisome (Unk)
  • Potassium Chloride (Unk)
  • Potassium Chloride (Unk)
.After starting to take Zolinza the consumer reported adverse symptoms, such as: Cardiac Failure CongestiveThese side effects may potentially be related to Zolinza. The patient was hospitalized.
Zolinza Side Effect Report#9410055
Pancreatitis Acute, Diabetes Mellitus
This is a report of a 66-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: mycosis fungoides,depression, who was treated with Zolinza (dosage: 400 Mg, Qd, start time:
Jul 12, 2012), combined with:
  • Effexor (75 Mg, Bid)
  • Effexor (Unk)
  • Hyperium
  • Levothyrox
  • Lexomil
  • Lasilix
  • Atarax (alprazolam)
  • Loxen
and developed a serious reaction and side effect(s): Pancreatitis Acute, Diabetes Mellitus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zolinza treatment in female patients, resulting in Pancreatitis Acute side effect. The patient was hospitalized.


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The appearance of Zolinza 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 Zolinza Side Effects for Men?

Men Side EffectsReports
Platelet Count Decreased 35
Anaemia 25
Nausea 20
Dehydration 17
Decreased Appetite 16
Malaise 13
Pneumonia 13
Diarrhoea 12
Mycosis Fungoides 11
Pyrexia 11

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    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.

    Zolinza 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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    Zolinza Safety Alerts, Active Ingredients, Usage Information

    NDC0006-0568
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameZOLINZA
    Namevorinostat
    Dosage FormCAPSULE
    RouteORAL
    On market since20061006
    LabelerMerck Sharp & Dohme Corp.
    Active Ingredient(s)VORINOSTAT
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassHistone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA]

    Zolinza Dosage, Warnings, Usage.

    Side Effects reported to FDA: 270

    Zolinza safety alerts: No

    Reported deaths: 65

    Reported hospitalizations: 125

    Latest Zolinza clinical trials

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