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Glakay Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Febrile Neutropenia, Hypertension, Platelet Count Decreased, White Blood Cell Count Decreased, Serum Ferritin Increased, Neutrophil Count Decreased (8463700-2)
on Jun 18, 2012 Male from JAPAN , weighting 149.9 lb, was treated with Glakay. Directly after, patient experienced the unwanted or unexpected Glakay side effects: febrile neutropenia, hypertension, platelet count decreased, white blood cell count decreased, serum ferritin increased, neutrophil count decreased. Glakay dosage: 45 Milligram.
Associated medications used:
  • Cefmetazole Sodium
  • Vidaza (75 Milligram/sq. Meter)
  • Vidaza (75 Milligram/sq. Meter)
  • Exjade
  • Decadron (4 Milligram)
  • Decadron (4 Milligram)
  • Decadron (4 Milligram)
  • Kytril (2 Milligram)
Patient was hospitalized.

Decreased Appetite, Nasopharyngitis, Somnolence (8413472-2)
Patient was taking Glakay. Patient felt the following Glakay side effects: decreased appetite, nasopharyngitis, somnolence on May 28, 2012 from JAPAN Additional patient health information: Female , 91 years of age, weighting 35.01 lb, was diagnosed with
  • osteoporosis
  • oedema peripheral
  • constipation
and. Glakay dosage: N/A.
Multiple prescriptions taken:
  • Lasix
  • Kamag G
  • Menatetrenone
  • Bisolvon
  • Rabeprazole Sodium
  • Livalo
  • Galantamine Hydrobromide
  • Rocaltrol
Patient was hospitalized.

Renal Failure, Respiratory Failure, Septic Shock, Multi-organ Failure (8236506-7)
Adverse event was reported on Mar 21, 2012 by a Male taking Glakay (Dosage: 15 Mg, Tid) . Location: JAPAN , weighting 119.0 lb, After Glakay was administered, patient encountered several Glakay side effects: renal failure, respiratory failure, septic shock, multi-organ failure.
Multiple concurrent drugs taken:
  • Asacol (Unk)
  • Famotidine (20 Mg, Uid/qd)
  • Miya Bm (2 Df, Tid)
  • Prednisolone (6.25 Mg, Bid)
  • Prograf (3 Mg, Bid)
  • Ferrous Citrate (2 Df, Uid/qd)
  • Loperamide Hcl (1 Mg, Uid/qd)


Pancytopenia (8157065-3)
on Feb 16, 2012 Female from JAPAN , weighting 99.21 lb, was treated with Glakay. Directly after, patient experienced the unwanted or unexpected Glakay side effects: pancytopenia. Glakay dosage: N/A.
Associated medications used:
  • Fosrenol
  • Mircera
  • Cinacalcet Hydrochloride
  • Rabeprazole Sodium
  • Urso 250
  • Risumic (In Front Of Hd)
  • Wasser V
  • Lac-b
Patient was hospitalized.


Sepsis, Epistaxis, Cellulitis, Myelodysplastic Syndrome (8112720-6)
on Jan 26, 2012 Female from JAPAN , weighting 141.1 lb, was treated with Glakay. Patient felt the following Glakay side effects: sepsis, epistaxis, cellulitis, myelodysplastic syndrome. Glakay dosage: N/A.
Multiple prescriptions taken:
  • Alfarol
  • Pursennid
  • Magnesium Sulfate
  • Vidaza (75 Milligram/sq. Meter)
  • Vfend
  • Ciprofloxacin
  • Mucodyne
  • Vidaza (37.5 Milligram/sq. Meter)
Patient was hospitalized.

Cerebral Haemorrhage, Fall, Speech Disorder (7954519-7)
Patient was taking Glakay. After Glakay was administered, patient encountered several Glakay side effects: cerebral haemorrhage, fall, speech disorder on Nov 22, 2011 from JAPAN Additional patient health information: Female , weighting 92.59 lb, . Glakay dosage: 45 Mg, Unk.
Multiple concurrent drugs taken:
  • Cephadol (75 Mg, Unk)
  • Platibit (1 Ug, Unk)
  • Amlodipine Besylate/valsartan (1 Df, Daily)
Patient was hospitalized and became disabled.

Septic Shock, Pneumonia, White Blood Cell Count Decreased (7781023-1)
Adverse event was reported on Sep 21, 2011 by a Male taking Glakay (Dosage: 45 Mg, Unk) was diagnosed with
  • myelodysplastic syndrome
  • prophylaxis
  • type 2 diabetes mellitus
and. Location: JAPAN , weighting 132.3 lb, Directly after, patient experienced the unwanted or unexpected Glakay side effects: septic shock, pneumonia, white blood cell count decreased.
Associated medications used:
  • Diflucan
  • Amaryl (1 Mg, Unk)
  • Diflucan (200 Mg, Unk)
  • Exjade (1000 Mg, Daily)
  • Lasix (10 Mg, Unk)
  • Aldactone (12.5 Mg, Unk)
  • Red Blood Cells, Concentrated (2 Units (every Week))
Patient was hospitalized.

Inflammatory Marker Increased, Pyrexia, Liver Disorder (7761998-7)
on Sep 13, 2011 Male from JAPAN , 62 years of age, weighting 125.7 lb, was treated with Glakay. Patient felt the following Glakay side effects: inflammatory marker increased, pyrexia, liver disorder. Glakay dosage: Daily Dose 45 Mg.
Multiple prescriptions taken:
  • Nizatidine (Daily Dose 300 Mg)
  • Lamivudine (Daily Dose 100 Mg)
  • Amoban (Daily Dose 5 Mg)
  • Nexavar (400 Mg, Bid)
  • Aldactone (Daily Dose 50 Mg)
  • Acetaminophen (Daily Dose 400 Mg)
  • Lasix (Daily Dose 20 Mg)
  • Loxonin (Daily Dose 60 Mg)
Patient was hospitalized.

Anaemia, Drowning, White Blood Cell Count Decreased, Mallory-weiss Syndrome, Hepatic Function Abnormal, Palmar-plantar Erythrodysaesthesia Syndrome, Hypertension (7714491-1)
on Aug 24, 2011 Male from JAPAN , 65 years of age, weighting 119.0 lb, was treated with Glakay. After Glakay was administered, patient encountered several Glakay side effects: anaemia, drowning, white blood cell count decreased, mallory-weiss syndrome, hepatic function abnormal, palmar-plantar erythrodysaesthesia syndrome, hypertension. Glakay dosage: Since Before Administration.
Multiple concurrent drugs taken:
  • Allopurinol (Since Before Administration)
  • Fentanyl
  • Lansoprazole (15 Mg (daily Dose), , Oral)
  • Nexavar
  • Uralyt (Since Before Administration)
  • Fentanyl (Since Before Administration, 2.1/3mg)
  • Oxinorm (Since Before Administration)
  • Fentanyl (Since Before Administration, 4.2/3mg)


Ileus Paralytic, Constipation, Dysuria (7648103-2)
Patient was taking Glakay. Directly after, patient experienced the unwanted or unexpected Glakay side effects: ileus paralytic, constipation, dysuria on Jul 20, 2011 from JAPAN Additional patient health information: Male , 64 years of age, . Glakay dosage: N/A.
Associated medications used:
  • Teleminsoft
  • Ondasetron
  • Vidaza (75 Milligram)
  • Alinamin-f
  • Vidaza (75 Milligram)
  • Magnesium Sulfate
  • Pantol
  • Primobolan
Patient was hospitalized.

White Blood Cell Count Decreased, Septic Shock, Pneumonia (7544466-7)
Adverse event was reported on Apr 12, 2010 by a Male taking Glakay (Dosage: 45 Mg, Unk) was diagnosed with
  • myelodysplastic syndrome
  • iron overload
  • type 2 diabetes mellitus
and. Location: JAPAN , weighting 132.3 lb, Patient felt the following Glakay side effects: white blood cell count decreased, septic shock, pneumonia.
Multiple prescriptions taken:
  • Exjade (100 Mg)
  • Amaryl (1 Mg, Unk)
  • Lasix (10 Mg, Unk)
  • Red Blood Cells, Concentrated (2 Units (every Week))
  • Aldactone (12.5 Mg, Unk)
  • Diflucan (200 Mg, Unk)
  • Diflucan
Patient was hospitalized.

Aspartate Aminotransferase Increased, Erythema Multiforme, Lip Erosion, Blood Creatine Phosphokinase Increased, Pyrexia, Alanine Aminotransferase Increased, Thrombocytopenia, Blood Albumin Decreased, Haemorrhage (7499213-4)
on May 11, 2011 Male from JAPAN , 78 years of age, was treated with Glakay. After Glakay was administered, patient encountered several Glakay side effects: aspartate aminotransferase increased, erythema multiforme, lip erosion, blood creatine phosphokinase increased, pyrexia, alanine aminotransferase increased, thrombocytopenia, blood albumin decreased, haemorrhage. Glakay dosage: 45 Mg (daily Dose), , Oral.
Multiple concurrent drugs taken:
  • Urso 250 (600 Mg (daily Dose), , Oral)
  • Rabeprazole Sodium (10 Mg (daily Dose), , Oral)
  • Uft (300 Mg (daily Dose), , Oral)
  • Adjust-a (80 Mg (daily Dose), , Oral)
  • Livact (12.45 G (daily Dose), , Oral)
  • Falkamin (12.45 G (daily Dose), , Oral)
  • Magnesium Sulfate (1980 Mg (daily Dose), , Oral)
  • Nexavar
Patient was hospitalized.

Neoplasm Malignant, Pneumonia, Pruritus, Gamma-glutamyltransferase Increased, Pancytopenia, Oral Pain, Serum Ferritin Increased, Toxic Epidermal Necrolysis, Erythema Multiforme (7347469-0)
on Mar 07, 2011 Female from JAPAN , weighting 99.21 lb, was diagnosed with
  • myelodysplastic syndrome
and was treated with Glakay. Directly after, patient experienced the unwanted or unexpected Glakay side effects: neoplasm malignant, pneumonia, pruritus, gamma-glutamyltransferase increased, pancytopenia, oral pain, serum ferritin increased, toxic epidermal necrolysis, erythema multiforme. Glakay dosage: 45 Mg.
Associated medications used:
  • Primobolan (Unk)
  • Exjade (1000 Mg, Qd)
  • Red Blood Cells (2 U, Unk)
Patient was hospitalized.

Bronchitis, Bacterial Infection, Dehydration, Pyrexia, Multi-organ Failure, Cough, Blood Creatinine Increased, Renal Failure (7344729-4)
Patient was taking Glakay. Patient felt the following Glakay side effects: bronchitis, bacterial infection, dehydration, pyrexia, multi-organ failure, cough, blood creatinine increased, renal failure on Mar 07, 2011 from JAPAN Additional patient health information: Female , weighting 88.18 lb, . Glakay dosage: 45 Mg, Unk.
Multiple prescriptions taken:
  • Exjade (500 Mg, Daily)
  • Neoral (100 Mg, Daily)
  • Desferal (500 Mg)
  • Neutrogin (2.50 Ug)
  • Clarithromycin (400 Mg)
  • Exjade (500 Mg Daily)
  • Neoral (75 Mg, Daily)
Patient was hospitalized.

Platelet Count Decreased, Haematocrit Decreased, Vomiting, Red Blood Cell Count Decreased, Haemoglobin Decreased, Nausea (7310813-4)
Adverse event was reported on Feb 21, 2011 by a Female taking Glakay (Dosage: 45 Mg, Unk) was diagnosed with
  • prophylaxis
and. Location: JAPAN , weighting 110.2 lb, After Glakay was administered, patient encountered several Glakay side effects: platelet count decreased, haematocrit decreased, vomiting, red blood cell count decreased, haemoglobin decreased, nausea.
Multiple concurrent drugs taken:
  • Red Blood Cells, Concentrated (02 Units Each Time)
  • Nasanyl (02 Df, Unk)
  • Exjade (1000 Mg Daily)
  • Takepron (15 Mg, Unk)
  • Adona (90 Mg, Unk)
  • Alfarol (03 Df, Unk)
  • Blood Transfusion, Auxiliary Products (Unk)


Hypertension, Insomnia, Hepatic Function Abnormal, Pollakiuria, Pyrexia (7249608-9)
on Dec 16, 2010 Male from JAPAN , weighting 125.7 lb, was treated with Glakay. Directly after, patient experienced the unwanted or unexpected Glakay side effects: hypertension, insomnia, hepatic function abnormal, pollakiuria, pyrexia. Glakay dosage: Before Nexavar Administration.
Associated medications used:
  • Mevalotin (Before Nexavar Administration)
  • Lendormin (0.25 Mg (daily Dose), , Oral)
  • Ursodeoxycholic Acid
  • Flivas (25 Mg (daily Dose), , Oral)
  • Allelock (Before Nexavar Administration)
  • Livact (Before Nexavar Administration)
  • Nexavar
  • Tryptanol (10 Mg (daily Dose), , Oral)


Hypoglycaemia, Palmar-plantar Erythrodysaesthesia Syndrome, Decreased Appetite (7232558-1)
on Jan 14, 2011 Female from JAPAN , weighting 70.55 lb, was diagnosed with
  • osteoporosis
  • gastric ulcer
  • back pain
  • hypoalbuminaemia
  • diarrhoea
and was treated with Glakay. Patient felt the following Glakay side effects: hypoglycaemia, palmar-plantar erythrodysaesthesia syndrome, decreased appetite. Glakay dosage: Daily Dose 45 Mg.
Multiple prescriptions taken:
  • Gastrom (Daily Dose 3 G)
  • Celecoxib (Daily Dose 200 Mg)
  • Livact (Daily Dose 12.45 G)
  • Lacb-r (Daily Dose 3 G)
  • Omepral (Daily Dose 20 Mg)
  • Sorafenib (raf Kinase Inhibitor) (Daily Dose 800 Mg)
  • Lopemin (Daily Dose 2 Mg)
  • Tannalbin (Daily Dose 3 G)


Chest Pain, Chills, Cough, Henoch-schonlein Purpura, Pneumonia, Pyrexia, Rash (5635963-X)
Patient was taking Glakay. After Glakay was administered, patient encountered several Glakay side effects: chest pain, chills, cough, henoch-schonlein purpura, pneumonia, pyrexia, rash on Feb 16, 2008 from JAPAN Additional patient health information: Male , 65 years of age, weighting 123.5 lb, was diagnosed with
  • myelodysplastic syndrome
and. Glakay dosage: N/A.
Multiple concurrent drugs taken:
  • Alfarol
  • Niflan
  • Neo-minophagen C
  • Loxonin
  • Exjade (1125 Mg, Qd)
Patient was hospitalized.

Chest Pain, Chills, Cough, Henoch-schonlein Purpura, Pneumonia, Pyrexia, Rash (5632909-5)
Adverse event was reported on Feb 16, 2008 by a Male taking Glakay (Dosage: N/A) was diagnosed with
  • myelodysplastic syndrome
and. Location: JAPAN , 65 years of age, weighting 123.5 lb, Directly after, patient experienced the unwanted or unexpected Glakay side effects: chest pain, chills, cough, henoch-schonlein purpura, pneumonia, pyrexia, rash.
Associated medications used:
  • Alfarol
  • Niflan
  • Neo-minophagen C
  • Loxonin
  • Exjade (1125 Mg, Qd)
Patient was hospitalized.

Aspartate Aminotransferase Increased, Disease Recurrence, Gamma-glutamyltransferase Increased, Hepatitis C (4560578-4)
on Nov 26, 2004 Female from , 66 years of age, was treated with Glakay. Patient felt the following Glakay side effects: aspartate aminotransferase increased, disease recurrence, gamma-glutamyltransferase increased, hepatitis c. Glakay dosage: 45 Mg, Unk.
Multiple prescriptions taken:
  • Urso 250 (600 Mg, Unk)
  • Cabagin-u (6 Df, Unk)
  • Diovan (40 Mg, Qd)
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Glakay Information

More About Glakay

Side Effects reported to FDA: 20. View Glakay Adverse Reports

Glakay safety alerts: No

Reported deaths: 6

Reported hospitalizations: 15

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