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Kuvan (Sapropterin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Kuvan (Sapropterin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (71)
Death (9)

Reports by Reaction Type

Maternal Exposure During Pregnancy (12)Abortion Spontaneous (9)Nephrolithiasis (4)Aspiration (4)Pneumonia (4)Microcephaly (4)Abdominal Pain (3)Laryngitis (3)Suicidal Ideation (3)Decreased Appetite (3)Migraine (3)Infection (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Kuvan (Sapropterin). For a complete list or a specific selection of reports, please use the links above.

Possible Kuvan side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 28.6 kg (62.9 pounds)

Reactions: Aspiration, Cerebrovascular Accident, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Kuvan
    Indication: Tetrahydrobiopterin Deficiency
    Start date: 2011-07-15

Kuvan
    Start date: 2011-10-29

Other drugs received by patient: Miralax; Leucovorin Calcium; Cyproheptadine HCL; Vitamin B-12; Prevacid; Peptamen; Vitamin D



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-14

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Abdominal Pain Lower

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: female, weighing 44.5 kg (97.9 pounds)

Reactions: Haematochezia, Anal Fistula, Constipation, Overgrowth Bacterial, Abdominal Pain Upper

Drug(s) suspected as cause:
Kuvan
    Administration route: Oral
    Start date: 2008-05-01

Kuvan
    Administration route: Oral
    Indication: Phenylketonuria
    Start date: 2008-05-17

Other drugs received by patient: Multi-Vitamins; Mineral TAB; Prevacid



Possible Kuvan side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female, weighing 96.3 kg (211.9 pounds)

Reactions: Cellulitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan
    Administration route: Oral
    Indication: Phenylketonuria
    Start date: 2010-08-01

Kuvan
    Administration route: Oral
    Start date: 2011-06-01

Other drugs received by patient: Multi-Vitamin



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male, weighing 62.7 kg (137.9 pounds)

Reactions: Death, Pneumonia, Upper Respiratory Tract Infection, Organ Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Synthroid; Claritin; Calcium Carbonate; Singulair; Albuterol; Nexium; Timolol Maleate; Carbitrol; Boniva; Colace; Citrical; Pulmicort; Kristalose; Buspar; Luvox; Ativan



Possible Kuvan side effects in 23 year old female

Reported by a physician from United States on 2012-08-06

Patient: 23 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Abdominal Discomfort, Inappropriate Schedule of Drug Administration, Accidental Overdose

Drug(s) suspected as cause:
Kuvan
    Dosage: 20 mg/kg or 11 tabs qd po
    Administration route: Oral
    Indication: Phenylketonuria
    Start date: 2009-03-13
    End date: 2009-04-10

Kuvan
    Dosage: 20 mg/kg or 11 tabs qd po
    Administration route: Oral
    Indication: Phenylketonuria
    Start date: 2012-07-21



Possible Kuvan side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-01

Patient: male, weighing 103.7 kg (228.1 pounds)

Reactions: Pneumonia, Flank Pain, Wheezing, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female, weighing 103.0 kg (226.6 pounds)

Reactions: Perforated Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Melatonin; Prilosec; Clindamycin; Zofran; Trazodone Hydrochloride; Sodium Chloride; Blood Transfusion; Ibuprofen; Vicodin; Amoxicillin; Zithromax; Pepcid; Ambien; Reglan; Nexium



Possible Kuvan side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: male, weighing 62.7 kg (137.9 pounds)

Reactions: Death, Pneumonia, Upper Respiratory Tract Infection, Organ Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Nexium; Luvox; Carbitrol; Claritin; Calcium Carbonate; Singulair; Boniva; Buspar; Ativan; Synthroid



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-30

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Diarrhoea, Hiccups

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2012-06-15

L-Arginine
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2012-05-03

Other drugs received by patient: Aricept; Simvastatin



Possible Kuvan side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-25

Patient: male, weighing 103.7 kg (228.1 pounds)

Reactions: Pneumonia, Flank Pain, Wheezing, Pyrexia

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-18

Patient: female, weighing 70.4 kg (154.9 pounds)

Reactions: Rectal Prolapse, Sepsis, Acute Respiratory Distress Syndrome, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-12

Patient: male

Reactions: Maternal Exposure During Pregnancy, Nuclear Magnetic Resonance Imaging Abnormal

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-12

Patient: male

Reactions: Atrial Septal Defect, Maternal Exposure During Pregnancy, Apnoea

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-11

Patient: male

Reactions: Foetal Growth Restriction, Microcephaly, Dysmorphism, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-11

Patient: female, weighing 70.4 kg (154.9 pounds)

Reactions: Rectal Prolapse, Sepsis, Acute Respiratory Distress Syndrome, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male

Reactions: Maternal Exposure During Pregnancy, Dysmyelination

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male

Reactions: Foetal Growth Restriction, Dysmorphism, Microcephaly, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male

Reactions: Atrial Septal Defect, Maternal Exposure During Pregnancy, Apnoea

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-03

Patient: female, weighing 70.2 kg (154.4 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from Germany on 2012-06-27

Patient: female, weighing 23.0 kg (50.6 pounds)

Reactions: Laryngitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Omeprazole



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from Canada on 2012-06-19

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Migraine

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Ibuprofen (Advil)



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from Germany on 2012-06-19

Patient: female, weighing 23.0 kg (50.6 pounds)

Reactions: Cyanosis, Laryngitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Omeprazole



Possible Kuvan side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Albuterol; Phenyl Free 2; Protonix; Proventil; Carafate; Flovent; Magnesium Hydroxide TAB; Strattera; Benadryl; Multi-Vitamin



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from Germany on 2012-06-15

Patient: female, weighing 23.0 kg (50.6 pounds)

Reactions: Laryngitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: Omeprazole



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-11

Patient: female, weighing 70.2 kg (154.4 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Kuvan



Possible Kuvan side effects in male

Reported by a individual with unspecified qualification from United States on 2012-06-06

Patient: male, weighing 94.3 kg (207.5 pounds)

Reactions: Nephrolithiasis, Unevaluable Event, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: XP Maxamum; Antibiotics



Possible Kuvan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-05

Patient: female, weighing 45.5 kg (100.1 pounds)

Reactions: Abdominal Pain, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan
    Administration route: Oral
    Indication: Phenylketonuria

Kuvan
    Administration route: Oral
    Start date: 2008-06-01

Other drugs received by patient: Flonase; Singulair; Hyoscyamine Sulfate; Amitriptyline HCL; Prilosec; Amlodipine; Culturelle; Ondansetron



Possible Kuvan side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: female, weighing 45.5 kg (100.1 pounds)

Reactions: Abdominal Pain, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan
    Administration route: Oral
    Indication: Phenylketonuria

Kuvan
    Administration route: Oral
    Start date: 2008-06-01

Other drugs received by patient: Ondansetron; Flonase; Culturelle; Prilosec; Singulair; Amlodipine Besylate; Hyoscyamine Sulfate



Possible Kuvan side effects in male

Reported by a individual with unspecified qualification from United States on 2012-05-23

Patient: male, weighing 94.3 kg (207.5 pounds)

Reactions: Nephrolithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kuvan

Other drugs received by patient: XP Maxamum

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