SAPROPTERIN DIHYDROCHLORIDE

N/A

Manufactured by BioMarin Pharmaceutical Inc.

8,360 FDA adverse event reports analyzed

Last updated: 2026-04-15

About SAPROPTERIN DIHYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BioMarin Pharmaceutical Inc.. The most commonly reported adverse reactions for SAPROPTERIN DIHYDROCHLORIDE include DRUG INEFFECTIVE, HEADACHE, THERAPY NON-RESPONDER, VOMITING, MATERNAL EXPOSURE DURING PREGNANCY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SAPROPTERIN DIHYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE366 reports
HEADACHE365 reports
THERAPY NON RESPONDER350 reports
VOMITING306 reports
MATERNAL EXPOSURE DURING PREGNANCY292 reports
DIARRHOEA274 reports
NAUSEA223 reports
ABDOMINAL PAIN UPPER212 reports
AMINO ACID LEVEL INCREASED201 reports
ANXIETY185 reports
ABDOMINAL DISCOMFORT172 reports
COUGH158 reports
NASOPHARYNGITIS152 reports
ARTHRALGIA146 reports
DIZZINESS143 reports
PYREXIA140 reports
DECREASED APPETITE137 reports
MALAISE136 reports
PSYCHOMOTOR HYPERACTIVITY132 reports
FATIGUE125 reports
RASH114 reports
MEMORY IMPAIRMENT99 reports
PRODUCT DOSE OMISSION ISSUE96 reports
WEIGHT DECREASED96 reports
WEIGHT INCREASED94 reports
EXPOSURE DURING PREGNANCY93 reports
COVID 1991 reports
DYSPEPSIA90 reports
OFF LABEL USE88 reports
OROPHARYNGEAL PAIN87 reports
DEPRESSION86 reports
ABDOMINAL PAIN85 reports
AGGRESSION83 reports
GASTROOESOPHAGEAL REFLUX DISEASE83 reports
RHINORRHOEA81 reports
INFLUENZA79 reports
OVERDOSE78 reports
HYPERSENSITIVITY75 reports
GASTROENTERITIS VIRAL74 reports
ABNORMAL BEHAVIOUR71 reports
URTICARIA69 reports
ABORTION SPONTANEOUS67 reports
PRODUCT PRESCRIBING ERROR67 reports
NASAL CONGESTION66 reports
CONSTIPATION65 reports
INSOMNIA65 reports
DYSPNOEA63 reports
PRODUCT DOSE OMISSION63 reports
INJECTION SITE REACTION61 reports
MIGRAINE60 reports
IRRITABILITY59 reports
PAIN57 reports
ILLNESS56 reports
FEELING ABNORMAL53 reports
EAR INFECTION52 reports
FLATULENCE52 reports
PRURITUS52 reports
ALOPECIA44 reports
ANGER44 reports
INJECTION SITE ERYTHEMA44 reports
AMINO ACID LEVEL DECREASED42 reports
PREGNANCY42 reports
TREATMENT NONCOMPLIANCE42 reports
SEIZURE41 reports
DISTURBANCE IN ATTENTION40 reports
MOOD ALTERED39 reports
SOMNOLENCE38 reports
GASTROINTESTINAL DISORDER37 reports
SINUSITIS37 reports
TREMOR37 reports
ABDOMINAL DISTENSION36 reports
ASTHENIA36 reports
VIRAL INFECTION36 reports
AGITATION35 reports
PNEUMONIA35 reports
DEATH33 reports
INJECTION SITE SWELLING33 reports
URINARY TRACT INFECTION31 reports
MOOD SWINGS30 reports
PAIN IN EXTREMITY30 reports
CHEST DISCOMFORT29 reports
CHEST PAIN29 reports
CHILLS28 reports
FALL28 reports
NEPHROLITHIASIS28 reports
NERVOUSNESS28 reports
PHARYNGITIS STREPTOCOCCAL28 reports
SEASONAL ALLERGY28 reports
AMINO ACID LEVEL ABNORMAL26 reports
INJECTION SITE RASH26 reports
DYSPHAGIA25 reports
ANAPHYLACTIC REACTION24 reports
BACK PAIN24 reports
GASTRITIS24 reports
INCORRECT DOSE ADMINISTERED24 reports
BEHAVIOUR DISORDER23 reports
CONVULSION23 reports
DEHYDRATION23 reports
UPPER RESPIRATORY TRACT INFECTION23 reports
HYPOPHAGIA22 reports

Report Outcomes

Out of 6,122 classified reports for SAPROPTERIN DIHYDROCHLORIDE:

Serious 17.2%Non-Serious 82.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female3,068 (60.9%)
Male1,964 (39.0%)
Unknown4 (0.1%)

Reports by Age

Age 294 reports
Age 485 reports
Age 376 reports
Age 174 reports
Age 774 reports
Age 871 reports
Age 569 reports
Age 1667 reports
Age 1363 reports
Age 2563 reports
Age 662 reports
Age 1062 reports
Age 2258 reports
Age 2458 reports
Age 2857 reports
Age 1256 reports
Age 1556 reports
Age 1455 reports
Age 2953 reports
Age 952 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with SAPROPTERIN DIHYDROCHLORIDE?

This profile reflects 8,360 FDA FAERS reports that mention SAPROPTERIN DIHYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SAPROPTERIN DIHYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, HEADACHE, THERAPY NON-RESPONDER, VOMITING, MATERNAL EXPOSURE DURING PREGNANCY, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SAPROPTERIN DIHYDROCHLORIDE?

Labeling and FAERS entries often list BioMarin Pharmaceutical Inc. in connection with SAPROPTERIN DIHYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.