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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