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Nipent Side Effects

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Common Nipent Side Effects


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

Sepsis (11)
Dyspnoea (9)
Nausea (8)
Dehydration (8)
Renal Failure (8)
Pyrexia (8)
Renal Failure Acute (7)
Atrial Fibrillation (7)
Chills (6)
Anaemia (6)
Febrile Neutropenia (6)
Pneumonia (6)
Neutrophil Count Decreased (6)
Tumour Lysis Syndrome (6)
Cardiomegaly (5)
Asthenia (5)
Diarrhoea (5)
Vomiting (5)
Pleural Effusion (4)
Pulmonary Oedema (4)

➢ 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.

Nipent Side Effects Reported to FDA



Nipent Side Effect Report#9837721
Neutrophil Count Decreased
This is a report of a 38-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Nipent (dosage: NA, start time:
Mar 23, 2009), combined with:
  • Rituximab
  • Cyclophosphamide
and developed a serious reaction and side effect(s): Neutrophil Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in female patients, resulting in Neutrophil Count Decreased side effect.
Nipent Side Effect Report#9837709
Platelet Count Decreased
This report suggests a potential Nipent Platelet Count Decreased side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia and used Nipent (dosage: NA) starting
Mar 23, 2009. After starting Nipent the patient began experiencing various side effects, including: Platelet Count DecreasedAdditional drugs used concurrently:
  • Rituximab
  • Cyclophosphamide
Although Nipent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Platelet Count Decreased, may still occur.
Nipent Side Effect Report#9837704
Hypercalcaemia Of Malignancy, Renal Failure Acute
This Hypercalcaemia Of Malignancy problem was reported by a consumer or non-health professional from US. A 55-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On NS this consumer started treatment with Nipent (dosage: NA). The following drugs were being taken at the same time: NA. When using Nipent, the patient experienced the following unwanted symptoms/side effects: Hypercalcaemia Of Malignancy, Renal Failure AcuteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypercalcaemia Of Malignancy, may become evident only after a product is in use by the general population.
Nipent Side Effect Report#9837697
Lung Infection
This Lung Infection side effect was reported by a physician from US. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Nipent (drug dosage: 8.6 Mg Milligram (s) (1 Day) Intravenous (not Otherwise Specified)), which was initiated on
Mar 05, 2013. Concurrently used drugs: NA..After starting to take Nipent the consumer reported adverse symptoms, such as: Lung InfectionThese side effects may potentially be related to Nipent. The patient was hospitalized.
Nipent Side Effect Report#9837648
Neutrophil Count Decreased
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Nipent (dosage: NA, start time:
Mar 03, 2012), combined with:
  • Cyclophosphamide
  • Rituximab
  • Alemtuzumab
and developed a serious reaction and side effect(s): Neutrophil Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in male patients, resulting in Neutrophil Count Decreased side effect.
Nipent Side Effect Report#9837627
Neutrophil Count Decreased
This report suggests a potential Nipent Neutrophil Count Decreased side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia and used Nipent (dosage: NA) starting
Oct 22, 2012. After starting Nipent the patient began experiencing various side effects, including: Neutrophil Count DecreasedAdditional drugs used concurrently:
  • (cyclophosphamide)
  • Rituximab
  • Campath
Although Nipent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutrophil Count Decreased, may still occur.
Nipent Side Effect Report#9547383
Febrile Neutropenia, Neutrophil Count Decreased, Chills
This Febrile Neutropenia problem was reported by a physician from US. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Feb 25, 2010 this consumer started treatment with Nipent (dosage: NA). The following drugs were being taken at the same time:
  • (cyclophosphamide)
  • Rituximab
When using Nipent, the patient experienced the following unwanted symptoms/side effects: Febrile Neutropenia, Neutrophil Count Decreased, ChillsAlthough 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.
Nipent Side Effect Report#9500632
Diarrhoea, Bone Marrow Failure, Acute Graft Versus Host Disease In Skin
This Diarrhoea side effect was reported by a pharmacist from US. A 18-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nipent (drug dosage: NA), which was initiated on
Dec 23, 2008. Concurrently used drugs:
  • Zenapax
  • Cyclosporine)
  • Prednisone
.After starting to take Nipent the consumer reported adverse symptoms, such as: Diarrhoea, Bone Marrow Failure, Acute Graft Versus Host Disease In SkinThese side effects may potentially be related to Nipent. The patient was hospitalized.
Nipent Side Effect Report#9404292
Lung Infection, Febrile Neutropenia, Weight Decreased, Decreased Appetite, Sinusitis, Hyponatraemia, Anaemia
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Nipent (dosage: Intravenous (not Otherwise Specified)?, start time:
May 29, 2013), combined with:
  • (cyclophosphamide) (Intravenous (not Otherwise Specified))
  • Rituximab (Intravenous (not Otherwise Specified))
  • Alemtuzumab
  • (voriconazole)
  • Avelox
and developed a serious reaction and side effect(s): Lung Infection, Febrile Neutropenia, Weight Decreased, Decreased Appetite, Sinusitis, Hyponatraemia, Anaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in male patients, resulting in Lung Infection side effect. The patient was hospitalized.
Nipent Side Effect Report#9226883
Febrile Neutropenia, Lung Infection
This report suggests a potential Nipent Febrile Neutropenia side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia and used Nipent (dosage: NA) starting
Oct 22, 2012. After starting Nipent the patient began experiencing various side effects, including: Febrile Neutropenia, Lung InfectionAdditional drugs used concurrently:
  • Cyclophosphamide
  • Rituximab
  • Alemtuzumab
The patient was hospitalized. Although Nipent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Febrile Neutropenia, may still occur.
Nipent Side Effect Report#9185297
Neutrophil Count Decreased, White Blood Cell Count Decreased, Platelet Count Decreased, Confusional State, Asthenia, Sepsis, Renal Failure, Respiratory Failure, Pneumonia
This Neutrophil Count Decreased problem was reported by a physician from US. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Dec 03, 2012 this consumer started treatment with Nipent (dosage: NA). The following drugs were being taken at the same time:
  • Cyclophosphamide
  • Rituximab
  • Alemtuzumab
When using Nipent, the patient experienced the following unwanted symptoms/side effects: Neutrophil Count Decreased, White Blood Cell Count Decreased, Platelet Count Decreased, Confusional State, Asthenia, Sepsis, Renal Failure, Respiratory Failure, 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 Neutrophil Count Decreased, may become evident only after a product is in use by the general population.
Nipent Side Effect Report#9053763
Myelodysplastic Syndrome, Haematotoxicity
This Myelodysplastic Syndrome side effect was reported by a health professional from US. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Nipent (drug dosage: NA), which was initiated on
Jan 23, 2012. Concurrently used drugs:
  • Rituximab
  • Alemtuzumab
  • Cyclophosphamide
  • Prochlorperazine
.After starting to take Nipent the consumer reported adverse symptoms, such as: Myelodysplastic Syndrome, HaematotoxicityThese side effects may potentially be related to Nipent.
Nipent Side Effect Report#8784698
Hyperuricaemia
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic lymphocytic leukemia, who was treated with Nipent (dosage: NA, start time:
Jul 06, 2005), combined with:
  • Cytoxan
  • Rituxan
and developed a serious reaction and side effect(s): Hyperuricaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in male patients, resulting in Hyperuricaemia side effect.
Nipent Side Effect Report#8436136-8
Cytolytic Hepatitis
This report suggests a potential Nipent Cytolytic Hepatitis side effect(s) that can have serious consequences. A 23-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Nipent (dosage: NA) starting
Feb 01, 2012. After starting Nipent the patient began experiencing various side effects, including: Cytolytic HepatitisAdditional drugs used concurrently:
  • Flagyl
  • Rocephin
The patient was hospitalized. Although Nipent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cytolytic Hepatitis, may still occur.
Nipent Side Effect Report#8225319
Neutropenia
This Neutropenia problem was reported by a health professional from US. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Feb 11, 2008 this consumer started treatment with Nipent (dosage: 4 Mg/m2 Day 1 ; 8.36 Mg). The following drugs were being taken at the same time:
  • Cyclophosphamide (600 Mg/m2 Day 1 ; 1254 Ng)
  • Rituximab
When using Nipent, the patient experienced the following unwanted symptoms/side effects: NeutropeniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neutropenia, may become evident only after a product is in use by the general population.
Nipent Side Effect Report#8055997
Sinus Congestion, Lymphopenia, Chills, Haemoglobin Decreased, Haematocrit Decreased, White Blood Cell Count Decreased, Tumour Associated Fever
This Sinus Congestion side effect was reported by a consumer or non-health professional from US. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Nipent (drug dosage: 4 Mg/m2, Day 1 Of Wks 1, 5, 9, 13, 17, 21),), which was initiated on NS. Concurrently used drugs:
  • Alemtuzumab (30 Mg, Tiw X 18 Wks, Subcutaneous)
  • Cyclophosphamide (600 Mg/m2, Day 1of Weeks 1, 5, 9, 13, 17, 21)
  • Rituximab (375 Mg/m2 On Weeks 1, 5, 9, 13, 17, 21: 1 3 Days/week For Week 1 And 1 Day/week For Weeks 5-21,)
.After starting to take Nipent the consumer reported adverse symptoms, such as: Sinus Congestion, Lymphopenia, Chills, Haemoglobin Decreased, Haematocrit Decreased, White Blood Cell Count Decreased, Tumour Associated FeverThese side effects may potentially be related to Nipent.
Nipent Side Effect Report#7980122-9
Dyspnoea, Musculoskeletal Stiffness, Ascites, Lung Infection, Anaemia, Cerebral Atrophy, Pleural Effusion, Cardiomegaly, Nuchal Rigidity
This is a report of a 70-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Nipent (dosage: 8 Mg, start time:
Dec 27, 2010), combined with:
  • Cyclophosphamide (1212 Mg,)
  • (alemtuzumab) (60 Mg,)
  • (rituximab) (758 Mg)
and developed a serious reaction and side effect(s): Dyspnoea, Musculoskeletal Stiffness, Ascites, Lung Infection, Anaemia, Cerebral Atrophy, Pleural Effusion, Cardiomegaly, Nuchal Rigidity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in male patients, resulting in Dyspnoea side effect. The patient was hospitalized.
Nipent Side Effect Report#7960910-5
Connective Tissue Disorder, Polymyositis, Mastication Disorder, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Dysphagia, Muscular Weakness, Aspartate Aminotransferase Increased, Musculoskeletal Disorder
This report suggests a potential Nipent Connective Tissue Disorder side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia and used Nipent (dosage: 10 Mg, Not Reported) starting
Sep 01, 2011. After starting Nipent the patient began experiencing various side effects, including: Connective Tissue Disorder, Polymyositis, Mastication Disorder, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Dysphagia, Muscular Weakness, Aspartate Aminotransferase Increased, Musculoskeletal DisorderAdditional drugs used concurrently:
  • (rituximab) (945 Mg, Not Reported)
  • Cyclophosphamide (1512 Mg, Not Reported)
Although Nipent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Connective Tissue Disorder, may still occur.
Nipent Side Effect Report#7870717-5
Blood Bilirubin Increased
This Blood Bilirubin Increased problem was reported by a health professional from United States. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Mar 07, 2011 this consumer started treatment with Nipent (dosage: 4 Mg/m2 X 1 Day On Weeks 1,5,9,13,17,21). The following drugs were being taken at the same time:
  • Cyclophosphamide (600 Mg/m2 X 1 Day On Weeks 1,5,9,13,17,21)
  • Rituxan (375 Mg/m2 On Weeks 1,5,9,13,17,21)
When using Nipent, the patient experienced the following unwanted symptoms/side effects: Blood Bilirubin IncreasedThe 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 Blood Bilirubin Increased, may become evident only after a product is in use by the general population.
Nipent Side Effect Report#7724347-6
Lymphopenia
This Lymphopenia side effect was reported by a health professional from United States. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Nipent (drug dosage: 4 Mg/m2, Day 1 Of Wks 1,5,9,13,17,21), which was initiated on
Apr 11, 2011. Concurrently used drugs:
  • Rituxan (375 Mg/m2 On Weeks 1,5,9,13,17,21 Week 1,3 Days/week; Week 5-21, 1day/week)
  • Cyclophosphamide (600 Mg/m2, Day 1 Of Weeks 1,5,9,13,17,21,)
.After starting to take Nipent the consumer reported adverse symptoms, such as: LymphopeniaThese side effects may potentially be related to Nipent.
Nipent Side Effect Report#7626370-9
Pyrexia, Chills, Sinus Congestion, Lymphopenia
This is a report of a 55-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Nipent (dosage: 45.5 Mg Total Dose, start time:
May 16, 2011), combined with:
  • Cyclophosphamide (6798 Mg Total Dose)
  • (rituximab) (5063 Mg Total Dose)
  • Campath (90 Mg Total Dose)
and developed a serious reaction and side effect(s): Pyrexia, Chills, Sinus Congestion, Lymphopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in male patients, resulting in Pyrexia side effect.
Nipent Side Effect Report#7618596-5
Renal Failure Acute, Confusional State
This report suggests a potential Nipent Renal Failure Acute side effect(s) that can have serious consequences. A 86-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Nipent (dosage: 1 Df, Q2wk) starting
Dec 27, 2010. After starting Nipent the patient began experiencing various side effects, including: Renal Failure Acute, Confusional StateAdditional drugs used concurrently:
  • Acetaminophen
  • Claforan (Unk)
  • Allopurinol (1 Df, Unk)
  • Ciprofloxacin (Unk)
  • Previscan (Daily Dose .75 Df)
  • Furosemide (Daily Dose 1 Df)
The patient was hospitalized. Although Nipent demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Nipent Side Effect Report#7125931-3
Haemodialysis, Renal Failure Acute, Tumour Lysis Syndrome
This Haemodialysis problem was reported by a physician from United States. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Aug 24, 2010 this consumer started treatment with Nipent (dosage: 7.7 Mg, Every 21 Days, Intravenous). The following drugs were being taken at the same time:
  • Cytoxan
  • Acyclovir
  • Bactrim
When using Nipent, the patient experienced the following unwanted symptoms/side effects: Haemodialysis, Renal Failure Acute, Tumour Lysis SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemodialysis, may become evident only after a product is in use by the general population.
Nipent Side Effect Report#7125869-1
Acute Pulmonary Oedema, Anaemia Haemolytic Autoimmune, Atelectasis, Blood Creatinine Increased, Blood Pressure Increased, Capillary Leak Syndrome, Chronic Lymphocytic Leukaemia Recurrent, Electromechanical Dissociation, Gastrointestinal Stromal Tumour
This Acute Pulmonary Oedema side effect was reported by a health professional from United States. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Nipent (drug dosage: 8 Mg, Total Dose Administered This Course), which was initiated on
Aug 30, 2010. Concurrently used drugs:
  • Cyclophosphamide (1200 Mg, Total Dose Administered This Course)
  • Rituximab (750 Mg, Total Dose Administered This Course)
.After starting to take Nipent the consumer reported adverse symptoms, such as: Acute Pulmonary Oedema, Anaemia Haemolytic Autoimmune, Atelectasis, Blood Creatinine Increased, Blood Pressure Increased, Capillary Leak Syndrome, Chronic Lymphocytic Leukaemia Recurrent, Electromechanical Dissociation, Gastrointestinal Stromal TumourThese side effects may potentially be related to Nipent. The patient was hospitalized.
Nipent Side Effect Report#7071225-4
Acute Pulmonary Oedema, Atelectasis, Blood Creatinine Increased, Electromechanical Dissociation, Haemolytic Anaemia, Pneumonia
This is a report of a 60-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Nipent (dosage: 8 Mg, Total Dose Administered This Course, start time:
Aug 30, 2010), combined with:
  • Cyclophosphamide (1200 Mg, Total Dose Administered This Course)
  • (rituximab) (750 Mg, Total Dose Administered This Course)
and developed a serious reaction and side effect(s): Acute Pulmonary Oedema, Atelectasis, Blood Creatinine Increased, Electromechanical Dissociation, Haemolytic Anaemia, Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nipent treatment in female patients, resulting in Acute Pulmonary Oedema side effect. The patient was hospitalized.


1 of 5 


The appearance of Nipent 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 Nipent Side Effects for Women?

Women Side EffectsReports
Nausea 7
Sepsis 6
Acute Pulmonary Oedema 4
Atrial Fibrillation 4
Balance Disorder 4
Dyspnoea 4
Electromechanical Dissociation 4
Vomiting 4
Anaemia 3
Asthenia 3

What are common Nipent Side Effects for Men?

Men Side EffectsReports
Dehydration 7
Pyrexia 7
Renal Failure 6
Cardiomegaly 5
Dyspnoea 5
Febrile Neutropenia 5
Sepsis 5
Tumour Lysis Syndrome 5
Chills 4
Cough 4

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  • Log Form

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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.

    Nipent 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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    Nipent Safety Alerts, Active Ingredients, Usage Information

    NDC0409-0801
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameNipent
    NamePENTOSTATIN
    Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    RouteINTRAVENOUS
    On market since19911011
    LabelerHospira, Inc.
    Active Ingredient(s)PENTOSTATIN
    Strength(s)2
    Unit(s)mg/mL
    Pharma ClassNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

    Nipent Dosage, Warnings, Usage.

    Side Effects reported to FDA: 121

    Nipent safety alerts: No

    Reported deaths: 34

    Reported hospitalizations: 87

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