OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Sapropterin Dihydrochloride

116 flagged reaction(s) · 5,789 total co-reports · max PRR 27.3
Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
Reaction Co-reports (a) PRR ROR Signal
1 Therapy Non-responder 364 27.3 28.9 signal
2 Psychomotor Hyperactivity 134 26.8 27.4 signal
3 Product Prescribing Error 143 20.1 20.6 signal
4 Gastroenteritis Viral 75 13.8 13.9 signal
5 Maternal Exposure During Pregnancy 301 11.3 11.8 signal
6 Pharyngitis Streptococcal 28 8.6 8.6 signal
7 Seasonal Allergy 30 7.0 7.1 signal
8 Pregnancy 42 6.9 6.9 signal
9 Ear Infection 54 6.7 6.8 signal
10 Abnormal Behaviour 71 5.9 6.0 signal
11 Abortion Spontaneous 67 5.5 5.6 signal
12 Aggression 83 5.5 5.5 signal
13 Exposure During Pregnancy 93 5.0 5.0 signal
14 Mood Altered 39 4.8 4.8 signal
15 Rhinorrhoea 85 4.4 4.4 signal
16 Anger 44 4.3 4.3 signal
17 Nasal Congestion 74 4.2 4.2 signal
18 Appendicitis 11 3.9 3.9 signal
19 Viral Infection 36 3.6 3.6 signal
20 Abdominal Discomfort 179 3.5 3.6 signal
21 Increased Appetite 20 3.5 3.5 signal
22 Gastrooesophageal Reflux Disease 85 3.5 3.5 signal
23 Abdominal Pain Upper 217 3.5 3.6 signal
24 Product Taste Abnormal 14 3.4 3.5 signal
25 Irritability 61 3.4 3.4 signal
26 Gastritis 26 3.3 3.3 signal
27 Oropharyngeal Pain 89 3.2 3.2 signal
28 Gastroenteritis 14 3.2 3.2 signal
29 Dyspepsia 94 3.2 3.2 signal
30 Product Dose Omission 63 3.2 3.2 signal
31 Mood Swings 30 3.1 3.1 signal
32 Flatulence 53 3.1 3.1 signal
33 Injection Site Reaction 62 3.0 3.0 signal
34 Pharyngitis 11 2.9 2.9 signal
35 Hypophagia 22 2.9 2.9 signal
36 Nasopharyngitis 160 2.9 2.9 signal
37 Injection Site Rash 26 2.8 2.8 signal
38 Hiatus Hernia 11 2.8 2.8 signal
39 Treatment Noncompliance 46 2.8 2.8 signal
40 Disturbance In Attention 44 2.7 2.7 signal
41 Influenza 86 2.5 2.6 signal
42 Caesarean Section 9 2.5 2.5 signal
43 Sneezing 17 2.5 2.5 signal
44 Eating Disorder 16 2.5 2.5 signal
45 Hunger 10 2.5 2.5 signal
46 Memory Impairment 101 2.4 2.5 signal
47 Pharyngeal Swelling 7 2.4 2.4 signal
48 Affect Lability 7 2.4 2.4 signal
49 Overdose 153 2.3 2.4 signal
50 Illness 69 2.3 2.3 signal
51 Gastric Ulcer 13 2.3 2.3 signal
52 Sars-cov-2 Test Positive 9 2.2 2.2 signal
53 Vomiting 314 2.2 2.3 signal
54 Anxiety 189 2.2 2.2 signal
55 Migraine 62 2.2 2.2 signal
56 Nephrolithiasis 29 2.1 2.1 signal
57 Dental Caries 7 2.1 2.1 no signal
58 Brain Fog 9 2.0 2.0 no signal
59 Retching 13 2.0 2.0 signal
60 Decreased Appetite 141 2.0 2.0 signal
61 Headache 378 2.0 2.1 no signal
62 Frequent Bowel Movements 16 2.0 2.0 no signal
63 Cough 166 2.0 2.0 no signal
64 Emotional Disorder 18 1.9 1.9 no signal
65 Weight Fluctuation 6 1.9 1.9 no signal
66 Crying 21 1.9 1.9 no signal
67 Secretion Discharge 7 1.9 1.9 no signal
68 Paraesthesia Oral 8 1.8 1.8 no signal
69 Drug Exposure During Pregnancy 19 1.8 1.8 no signal
70 Panic Attack 20 1.8 1.8 no signal
71 Injection Site Induration 7 1.8 1.8 no signal
72 Nervousness 28 1.8 1.8 no signal
73 Premature Baby 16 1.8 1.8 no signal
74 Anaphylactic Reaction 29 1.7 1.8 no signal
75 Covid-19 92 1.7 1.7 no signal
76 Knee Operation 5 1.7 1.7 no signal
77 Parkinsonism 5 1.7 1.7 no signal
78 Faeces Discoloured 11 1.7 1.7 no signal
79 Salivary Hypersecretion 5 1.7 1.7 no signal
80 Restlessness 18 1.6 1.6 no signal
81 Throat Tightness 13 1.6 1.6 no signal
82 Agitation 35 1.6 1.6 no signal
83 Feeling Jittery 9 1.6 1.6 no signal
84 Bipolar Disorder 5 1.5 1.5 no signal
85 Injection Site Swelling 34 1.5 1.5 no signal
86 Sinus Congestion 6 1.5 1.5 no signal
87 Muscle Twitching 10 1.4 1.4 no signal
88 Gastric Disorder 15 1.4 1.4 no signal
89 Personality Change 4 1.4 1.4 no signal
90 Urticaria 70 1.4 1.4 no signal
91 Injection Site Urticaria 10 1.4 1.4 no signal
92 Choking 8 1.4 1.4 no signal
93 Dystonia 8 1.4 1.4 no signal
94 Paranoia 7 1.3 1.3 no signal
95 No Therapeutic Response 5 1.3 1.3 no signal
96 Convulsion 23 1.3 1.3 no signal
97 Gallbladder Disorder 7 1.3 1.3 no signal
98 Product Use Complaint 6 1.3 1.3 no signal
99 Throat Irritation 17 1.3 1.3 no signal
100 Respiratory Tract Congestion 6 1.2 1.2 no signal
101 Product Dose Omission Issue 106 1.2 1.2 no signal
102 Injection Site Erythema 45 1.2 1.2 no signal
103 Injection Site Pruritus 23 1.1 1.1 no signal
104 Anosmia 5 1.1 1.1 no signal
105 Muscle Rigidity 4 1.1 1.1 no signal
106 Schizophrenia 4 1.1 1.1 no signal
107 Premature Delivery 5 1.0 1.0 no signal
108 Injection Site Warmth 6 1.0 1.0 no signal
109 Serotonin Syndrome 5 0.9 0.9 no signal
110 Product Physical Issue 5 0.8 0.8 no signal
111 Extra Dose Administered 10 0.8 0.8 no signal
112 Dysmenorrhoea 3 0.8 0.8 no signal
113 Circumstance Or Information Capable Of Leading To Medication Error 7 0.7 0.7 no signal
114 Product Substitution Issue 12 0.7 0.7 no signal
115 Injection Site Bruising 11 0.5 0.5 no signal
116 Menstruation Irregular 3 0.4 0.4 no signal