sapropterin
(FNKQXYHWGSIFBK-RPDRRWSUSA-N)
Structure
- SMILES
- C[C@@H]([C@@H]([C@H]1CNc2c(N1)c(=O)[nH]c(n2)N)O)O
- Type(s)
- Approved; Investigational
- ATC code(s)
- A16AX07
- Molecular Formula:
- C9H15N5O3
- Molecular Weight:
- 241.247
- Log P:
- -0.8430
- Hydrogen Bond Acceptor:
- 7
- Hydrogen Bond Donor:
- 6
- TPSA:
- 136.29
- CAS Number(s):
- 27070-47-9; 62989-33-7
Synonym(s)
1.
sapropterin
2.
1-butanone, 1-(2,4,5-trihydroxyphenyl)
3.
2',4',5'-trihydroxybutyrophenone
4.
2,4,5-trihydroxybutyrophenone
5.
5,6,7,8-erythro-tetrahydrobiopterin
6.
5,6,7,8-tetrahydro-L-erythrobiopterin
7.
5,6,7,8-tetrahydrobiopterin
8.
5,6,7,8-tetrahydrobiopterin, (S-(R*,S*))-isomer
9.
5,6,7,8-tetrahydrodictyopterin
10.
6R-BH4
11.
6R-L-erythro-5,6,7,8-tetrahydrobiopterin
12.
D-threo-tetrahydrobiopterin
13.
THBP
14.
kuvan
15.
phenylalanine hydroxylase cofactor
16.
sapropterin dihydrochloride
17.
tetrahydro-6-biopterin
18.
tetrahydrobiopterin
19.
trihydroxybutyrophenone
External Link(s)
Adverse Drug Event(s)
| Name | Number of Reports | Reference(s) | Data Source | |
|---|---|---|---|---|
| 1 | Drug ineffective | FAERS: 258 | US FAERS | |
| 2 | Therapy non-responder | FAERS: 220 | US FAERS | |
| 3 | Headache | FAERS: 169 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 4 | Vomiting | FAERS: 148 Canada Vigilance: 2 | Canada Vigilance US FAERS | |
| 5 | Maternal exposure during pregnancy | FAERS: 111 Canada Vigilance: 2 | Canada Vigilance US FAERS | |
| 6 | Nausea | FAERS: 88 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 7 | Abdominal discomfort | FAERS: 74 | US FAERS | |
| 8 | Malaise | FAERS: 72 | US FAERS | |
| 9 | Anxiety | FAERS: 70 Canada Vigilance: 3 | Canada Vigilance US FAERS | |
| 10 | Dizziness | FAERS: 65 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 11 | Nasopharyngitis | FAERS: 61 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 12 | Amino acid level increased | FAERS: 44 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 13 | Oropharyngeal pain | FAERS: 44 | US FAERS | |
| 14 | Influenza | FAERS: 42 | US FAERS | |
| 15 | Fatigue | FAERS: 38 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 16 | Dyspepsia | FAERS: 35 | US FAERS | |
| 17 | Weight decreased | FAERS: 35 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 18 | Abdominal Pain | FAERS: 33 | US FAERS | |
| 19 | Pregnancy | FAERS: 27 | US FAERS | |
| 20 | Alopecia | FAERS: 26 | US FAERS | |
| 21 | Anger | FAERS: 22 | US FAERS | |
| 22 | Constipation | FAERS: 22 | US FAERS | |
| 23 | Flatulence | FAERS: 22 | US FAERS | |
| 24 | Mood swings | FAERS: 21 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 25 | Feeling abnormal | FAERS: 19 | US FAERS | |
| 26 | Memory impairment | FAERS: 19 | US FAERS | |
| 27 | Sinusitis | FAERS: 19 | US FAERS | |
| 28 | Nephrolithiasis | FAERS: 18 | US FAERS | |
| 29 | Tremor | FAERS: 18 | US FAERS | |
| 30 | Hypersensitivity | FAERS: 16 | US FAERS | |
| 31 | Hypophagia | FAERS: 15 | US FAERS | |
| 32 | Pruritus | FAERS: 15 | US FAERS | |
| 33 | Agitation | FAERS: 14 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 34 | Pain | FAERS: 14 | US FAERS | |
| 35 | Amino acid level decreased | FAERS: 13 | US FAERS | |
| 36 | Drug exposure during pregnancy | FAERS: 13 | US FAERS | |
| 37 | Lethargy | FAERS: 13 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 38 | Urticaria | FAERS: 13 | US FAERS | |
| 39 | Asthenia | FAERS: 11 | US FAERS | |
| 40 | Gastritis | FAERS: 11 | US FAERS | |
| 41 | Somnolence | FAERS: 11 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 42 | Arthralgia | FAERS: 10 | US FAERS | |
| 43 | Nervousness | FAERS: 10 | US FAERS | |
| 44 | Pneumonia | FAERS: 10 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 45 | Product dose omission | FAERS: 10 | US FAERS | |
| 46 | Urinary tract infection | FAERS: 10 | US FAERS | |
| 47 | Bronchitis | FAERS: 9 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 48 | Chest Pain | FAERS: 9 | US FAERS | |
| 49 | Stress | FAERS: 9 | US FAERS | |
| 50 | Chills | FAERS: 8 | US FAERS | |
| 51 | Dehydration | FAERS: 8 | US FAERS | |
| 52 | Emotional disorder | FAERS: 8 | US FAERS | |
| 53 | Incorrect dose administered | FAERS: 8 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 54 | Restlessness | FAERS: 8 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 55 | Retching | FAERS: 8 | US FAERS | |
| 56 | Accidental overdose | FAERS: 7 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 57 | Depressed mood | FAERS: 7 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 58 | Epistaxis | FAERS: 7 | US FAERS | |
| 59 | Infection | FAERS: 7 | US FAERS | |
| 60 | Throat irritation | FAERS: 7 | US FAERS | |
| 61 | Amnesia | FAERS: 6 | US FAERS | |
| 62 | Anal abscess | FAERS: 6 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 63 | Dental caries | FAERS: 6 | US FAERS | |
| 64 | Dysgeusia | FAERS: 6 | US FAERS | |
| 65 | Gastroenteritis | FAERS: 6 | US FAERS | |
| 66 | Microcephaly | FAERS: 6 | US FAERS | |
| 67 | Musculoskeletal stiffness | FAERS: 6 | US FAERS | |
| 68 | Overdose | FAERS: 6 | US FAERS | |
| 69 | Asthma | FAERS: 5 | US FAERS | |
| 70 | Back Pain | FAERS: 5 | US FAERS | |
| 71 | Cellulitis | FAERS: 5 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 72 | Chest discomfort | FAERS: 5 | US FAERS | |
| 73 | Conjunctivitis | FAERS: 5 | US FAERS | |
| 74 | Crying | FAERS: 5 | US FAERS | |
| 75 | Flushing | FAERS: 5 | US FAERS | |
| 76 | Gastric ulcer | FAERS: 5 | US FAERS | |
| 77 | Limb injury | FAERS: 5 | US FAERS | |
| 78 | Medication Error | FAERS: 5 | US FAERS | |
| 79 | Myalgia | FAERS: 5 | US FAERS | |
| 80 | Palpitations | FAERS: 5 | US FAERS | |
| 81 | Pharyngitis | FAERS: 5 | US FAERS | |
| 82 | Poor quality sleep | FAERS: 5 | US FAERS | |
| 83 | Sneezing | FAERS: 5 | US FAERS | |
| 84 | Tonsillitis | FAERS: 5 | US FAERS | |
| 85 | Ulcer | FAERS: 5 | US FAERS | |
| 86 | Vertigo | FAERS: 5 | US FAERS | |
| 87 | Wheezing | FAERS: 5 | US FAERS | |
| 88 | Acne | FAERS: 4 | US FAERS | |
| 89 | Cystitis | FAERS: 4 | US FAERS | |
| 90 | Disorientation | FAERS: 4 | US FAERS | |
| 91 | Drug dose omission | FAERS: 4 | US FAERS | |
| 92 | Enuresis | FAERS: 4 | US FAERS | |
| 93 | Erythema | FAERS: 4 | US FAERS | |
| 94 | Inappropriate schedule of drug administration | FAERS: 4 | US FAERS | |
| 95 | Low birth weight baby | FAERS: 4 | US FAERS | |
| 96 | Paranoia | FAERS: 4 | US FAERS | |
| 97 | Product taste abnormal | FAERS: 4 | US FAERS | |
| 98 | Rash erythematous | FAERS: 4 | US FAERS | |
| 99 | Supraventricular tachycardia | FAERS: 4 | US FAERS | |
| 100 | Therapy partial responder | FAERS: 4 | US FAERS | |
| 101 | Thrombosis | FAERS: 4 | US FAERS | |
| 102 | Viral upper respiratory tract infection | FAERS: 4 | US FAERS | |
| 103 | Visual Impairment | FAERS: 4 | US FAERS | |
| 104 | Animal bite | FAERS: 3 | US FAERS | |
| 105 | Appendicitis | FAERS: 3 | US FAERS | |
| 106 | Cholelithiasis | FAERS: 3 | US FAERS | |
| 107 | Croup infectious | FAERS: 3 | US FAERS | |
| 108 | Deafness | FAERS: 3 | US FAERS | |
| 109 | Discomfort | FAERS: 3 | US FAERS | |
| 110 | Drug administration error | FAERS: 3 | US FAERS | |
| 111 | Dry skin | FAERS: 3 | US FAERS | |
| 112 | Dysmorphism | FAERS: 3 | US FAERS | |
| 113 | Dystonia | FAERS: 3 | US FAERS | |
| 114 | Eczema | FAERS: 3 | US FAERS | |
| 115 | Emotional distress | FAERS: 3 | US FAERS | |
| 116 | Flank Pain | FAERS: 3 | US FAERS | |
| 117 | Food Poisoning | FAERS: 3 | US FAERS | |
| 118 | Gestational Diabetes | FAERS: 3 | US FAERS | |
| 119 | Hepatomegaly | FAERS: 3 | US FAERS | |
| 120 | Hypotension | FAERS: 3 | US FAERS | |
| 121 | Hypothyroidism | FAERS: 3 | US FAERS | |
| 122 | Lymphadenopathy | FAERS: 3 | US FAERS | |
| 123 | Musculoskeletal Pain | FAERS: 3 | US FAERS | |
| 124 | Pierre Robin Syndrome | FAERS: 3 | US FAERS | |
| 125 | Product physical issue | FAERS: 3 | US FAERS | |
| 126 | Productive Cough | FAERS: 3 | US FAERS | |
| 127 | Respiratory distress | FAERS: 3 | US FAERS | |
| 128 | Sepsis | FAERS: 3 | US FAERS | |
| 129 | Syncope | FAERS: 3 | US FAERS | |
| 130 | Toothache | FAERS: 3 | US FAERS | |
| 131 | Adenoidectomy | FAERS: 2 | US FAERS | |
| 132 | Adverse event | FAERS: 2 | US FAERS | |
| 133 | Alcohol poisoning | FAERS: 2 | US FAERS | |
| 134 | Altered state of consciousness | FAERS: 2 | US FAERS | |
| 135 | Anal Fistula | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 136 | Anorexia | FAERS: 2 | US FAERS | |
| 137 | Arthropathy | FAERS: 2 | US FAERS | |
| 138 | Aspartate Aminotransferase Increased | FAERS: 2 | US FAERS | |
| 139 | Atrial Fibrillation | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 140 | Blighted ovum | FAERS: 2 | US FAERS | |
| 141 | Blood urine present | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 142 | Bradycardia | FAERS: 2 | US FAERS | |
| 143 | Breast Cyst | FAERS: 2 | US FAERS | |
| 144 | Bronchiolitis | FAERS: 2 | US FAERS | |
| 145 | Bruxism | FAERS: 2 | US FAERS | |
| 146 | Chorioamnionitis | FAERS: 2 | US FAERS | |
| 147 | Diabetes Mellitus | FAERS: 2 | US FAERS | |
| 148 | Drooling | FAERS: 2 | US FAERS | |
| 149 | Dysphemia | FAERS: 2 | US FAERS | |
| 150 | Ectopic Pregnancy | FAERS: 2 | US FAERS | |
| 151 | Epigastric discomfort | FAERS: 2 | US FAERS | |
| 152 | Epilepsy | FAERS: 2 | US FAERS | |
| 153 | Gallbladder pain | FAERS: 2 | US FAERS | |
| 154 | Gastric infection | FAERS: 2 | US FAERS | |
| 155 | Hyperchlorhydria | FAERS: 2 | US FAERS | |
| 156 | Hypersomnia | FAERS: 2 | US FAERS | |
| 157 | Hypokinesia | FAERS: 2 | US FAERS | |
| 158 | Impaired gastric emptying | FAERS: 2 | US FAERS | |
| 159 | Infected cyst | FAERS: 2 | US FAERS | |
| 160 | Inflammation | FAERS: 2 | US FAERS | |
| 161 | Initial insomnia | FAERS: 2 | US FAERS | |
| 162 | Intentional product misuse | FAERS: 2 | US FAERS | |
| 163 | Labyrinthitis | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 164 | Laryngitis | FAERS: 2 | US FAERS | |
| 165 | Leukocytosis | FAERS: 2 | US FAERS | |
| 166 | Myocardial Infarction | FAERS: 2 | US FAERS | |
| 167 | Myoclonus | FAERS: 2 | US FAERS | |
| 168 | Nasal discomfort | FAERS: 2 | US FAERS | |
| 169 | Neck Pain | FAERS: 2 | US FAERS | |
| 170 | Neutropenia | FAERS: 2 | US FAERS | |
| 171 | Occupational exposure to product | FAERS: 2 | US FAERS | |
| 172 | Oligohydramnios | FAERS: 2 | US FAERS | |
| 173 | Pancreatitis | FAERS: 2 | US FAERS | |
| 174 | Pneumothorax | FAERS: 2 | US FAERS | |
| 175 | Presyncope | FAERS: 2 | US FAERS | |
| 176 | Product label issue | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 177 | Product quality issue | FAERS: 2 | US FAERS | |
| 178 | Protein urine present | FAERS: 2 | US FAERS | |
| 179 | Rectal Prolapse | FAERS: 2 | US FAERS | |
| 180 | Renal cyst | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 181 | Respiratory tract congestion | FAERS: 2 | US FAERS | |
| 182 | Schizophrenia | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 183 | Secretion discharge | FAERS: 2 | US FAERS | |
| 184 | Sinus headache | FAERS: 2 | US FAERS | |
| 185 | Spinal column stenosis | FAERS: 2 | US FAERS | |
| 186 | Staphylococcal abscess | FAERS: 2 | US FAERS | |
| 187 | Tachyphrenia | FAERS: 2 | US FAERS | |
| 188 | Thyroid Neoplasm | FAERS: 2 | US FAERS | |
| 189 | Tinnitus | FAERS: 2 | US FAERS | |
| 190 | Tooth Infection | FAERS: 2 | US FAERS | |
| 191 | Urinary Incontinence | FAERS: 2 | US FAERS | |
| 192 | Uterine spasm | FAERS: 2 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 193 | 5-hydroxyindolacetic acid decreased | FAERS: 1 | US FAERS | |
| 194 | Abnormal palmar/plantar creases | FAERS: 1 | US FAERS | |
| 195 | Abscess | FAERS: 1 | US FAERS | |
| 196 | Accidental exposure to product | FAERS: 1 | US FAERS | |
| 197 | Accidental exposure to product by child | FAERS: 1 | US FAERS | |
| 198 | Accidental underdose | FAERS: 1 | US FAERS | |
| 199 | Acidosis | FAERS: 1 | US FAERS | |
| 200 | Amniotic fluid volume decreased | FAERS: 1 | US FAERS | |
| 201 | Anal Fissure | FAERS: 1 | US FAERS | |
| 202 | Anal erosion | FAERS: 1 | US FAERS | |
| 203 | Angina Pectoris | FAERS: 1 | US FAERS | |
| 204 | Anisomastia | FAERS: 1 | US FAERS | |
| 205 | Ankle Fracture | FAERS: 1 | US FAERS | |
| 206 | Anorectal discomfort | FAERS: 1 | US FAERS | |
| 207 | Anosmia | FAERS: 1 | US FAERS | |
| 208 | Arthritis | FAERS: 1 | US FAERS | |
| 209 | Atrial tachycardia | FAERS: 1 | US FAERS | |
| 210 | Atypical pneumonia | FAERS: 1 | US FAERS | |
| 211 | Bacillus infection | FAERS: 1 | US FAERS | |
| 212 | Belligerence | FAERS: 1 | US FAERS | |
| 213 | Bipolar Disorder | FAERS: 1 | US FAERS | |
| 214 | Blindness | FAERS: 1 | US FAERS | |
| 215 | Blood blister | FAERS: 1 | US FAERS | |
| 216 | Blood catecholamines decreased | FAERS: 1 | US FAERS | |
| 217 | Blood cholesterol increased | FAERS: 1 | US FAERS | |
| 218 | Blood creatinine increased | FAERS: 1 | US FAERS | |
| 219 | Blood glucose decreased | FAERS: 1 | US FAERS | |
| 220 | Blood glucose increased | FAERS: 1 | US FAERS | |
| 221 | Blood potassium decreased | FAERS: 1 | US FAERS | |
| 222 | Blood triglycerides increased | FAERS: 1 | US FAERS | |
| 223 | Blood zinc decreased | FAERS: 1 | US FAERS | |
| 224 | Bone pain | FAERS: 1 | US FAERS | |
| 225 | Bursitis | FAERS: 1 | US FAERS | |
| 226 | Cardiac Arrest | FAERS: 1 | US FAERS | |
| 227 | Catarrh | FAERS: 1 | US FAERS | |
| 228 | Cerebral Palsy | FAERS: 1 | US FAERS | |
| 229 | Cerebral calcification | FAERS: 1 | US FAERS | |
| 230 | Cerebrovascular accident | FAERS: 1 | US FAERS | |
| 231 | Cervix carcinoma | FAERS: 1 | US FAERS | |
| 232 | Choking | FAERS: 1 | US FAERS | |
| 233 | Cholecystitis | FAERS: 1 | US FAERS | |
| 234 | Chromaturia | FAERS: 1 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 235 | Clumsiness | FAERS: 1 | US FAERS | |
| 236 | Complex partial seizures | FAERS: 1 | US FAERS | |
| 237 | Consciousness fluctuating | FAERS: 1 | US FAERS | |
| 238 | Culture positive | FAERS: 1 | US FAERS | |
| 239 | Cyst | FAERS: 1 | US FAERS | |
| 240 | Dengue Fever | FAERS: 1 | US FAERS | |
| 241 | Dermatitis | FAERS: 1 | US FAERS | |
| 242 | Diabetes Insipidus | FAERS: 1 | US FAERS | |
| 243 | Diabetic Ketoacidosis | FAERS: 1 | US FAERS | |
| 244 | Diplopia | FAERS: 1 | US FAERS | |
| 245 | Disease Progression | FAERS: 1 | US FAERS | |
| 246 | Disease complication | FAERS: 1 | US FAERS | |
| 247 | Dissociation | FAERS: 1 | US FAERS | |
| 248 | Diverticulitis | FAERS: 1 | US FAERS | |
| 249 | Drug dispensing error | FAERS: 1 | US FAERS | |
| 250 | Drug effect variable | FAERS: 1 | US FAERS | |
| 251 | Drug prescribing error | FAERS: 1 | US FAERS | |
| 252 | Duodenal atresia | FAERS: 1 | US FAERS | |
| 253 | Duodenitis | FAERS: 1 | US FAERS | |
| 254 | Dysarthria | FAERS: 1 | US FAERS | |
| 255 | Dysmyelination | FAERS: 1 | US FAERS | |
| 256 | Dysuria | FAERS: 1 | US FAERS | |
| 257 | Economic problem | FAERS: 1 | US FAERS | |
| 258 | Educational problem | FAERS: 1 | US FAERS | |
| 259 | Elevated mood | FAERS: 1 | US FAERS | |
| 260 | Escherichia infection | FAERS: 1 | US FAERS | |
| 261 | Excoriation | FAERS: 1 | US FAERS | |
| 262 | Exposure during breast feeding | FAERS: 1 | US FAERS | |
| 263 | Exposure via ingestion | FAERS: 1 | US FAERS | |
| 264 | Extra dose administered | FAERS: 1 | US FAERS | |
| 265 | Eye inflammation | FAERS: 1 | US FAERS | |
| 266 | Facial paralysis | FAERS: 1 | US FAERS | |
| 267 | Failure to Thrive | FAERS: 1 | US FAERS | |
| 268 | Feeling Cold | FAERS: 1 | US FAERS | |
| 269 | Fibroadenoma of breast | FAERS: 1 | US FAERS | |
| 270 | Fibromuscular Dysplasia | FAERS: 1 | US FAERS | |
| 271 | Fibromyalgia | FAERS: 1 | US FAERS | |
| 272 | Foaming at mouth | FAERS: 1 | US FAERS | |
| 273 | Frustration | FAERS: 1 | US FAERS | |
| 274 | Gamma-Glutamyltransferase Increased | FAERS: 1 | US FAERS | |
| 275 | Gastric Dilatation | FAERS: 1 | US FAERS | |
| 276 | Gastrointestinal Pain | FAERS: 1 | US FAERS | |
| 277 | Gastrointestinal viral infection | FAERS: 1 | US FAERS | |
| 278 | Growing pains | FAERS: 1 | US FAERS | |
| 279 | Guillain-Barre Syndrome | FAERS: 1 | US FAERS | |
| 280 | Hemiparaesthesia | FAERS: 1 | US FAERS | |
| 281 | Hemiparesis | FAERS: 1 | US FAERS | |
| 282 | Hemiplegia | FAERS: 1 | US FAERS | |
| 283 | Hepatitis C | FAERS: 1 | US FAERS | |
| 284 | Hereditary spherocytosis | FAERS: 1 | US FAERS | |
| 285 | Hernia | FAERS: 1 | US FAERS | |
| 286 | Hordeolum | FAERS: 1 | US FAERS | |
| 287 | Hyperemesis Gravidarum | FAERS: 1 | US FAERS | |
| 288 | Hyperinsulinism | FAERS: 1 | US FAERS | |
| 289 | Hyperphagia | FAERS: 1 | US FAERS | |
| 290 | Hyperthyroidism | FAERS: 1 | US FAERS | |
| 291 | Hyperventilation | FAERS: 1 | US FAERS | |
| 292 | Hypoxia | FAERS: 1 | US FAERS | |
| 293 | Hysterectomy | FAERS: 1 | US FAERS | |
| 294 | Impaired driving ability | FAERS: 1 | US FAERS | |
| 295 | Impaired self-care | FAERS: 1 | US FAERS | |
| 296 | Inappropriate affect | FAERS: 1 | US FAERS | |
| 297 | Incision site abscess | FAERS: 1 | US FAERS | |
| 298 | Incision site infection | FAERS: 1 | US FAERS | |
| 299 | Incontinence | FAERS: 1 | US FAERS | |
| 300 | Increased viscosity of upper respiratory secretion | FAERS: 1 | US FAERS | |
| 301 | Infantile vomiting | FAERS: 1 | US FAERS | |
| 302 | Infectious Mononucleosis | FAERS: 1 | US FAERS | |
| 303 | Intentional product use issue | FAERS: 1 | US FAERS | |
| 304 | Intestinal Perforation | FAERS: 1 | US FAERS | |
| 305 | Joint swelling | FAERS: 1 | US FAERS | |
| 306 | Ketonuria | FAERS: 1 | US FAERS | |
| 307 | Limb asymmetry | FAERS: 1 | US FAERS | |
| 308 | Lipoma | FAERS: 1 | US FAERS | |
| 309 | Live Birth | FAERS: 1 | US FAERS | |
| 310 | Lobar Pneumonia | FAERS: 1 | US FAERS | |
| 311 | Lung cyst | FAERS: 1 | US FAERS | |
| 312 | Lyme Disease | FAERS: 1 | US FAERS | |
| 313 | Malnutrition | FAERS: 1 | US FAERS | |
| 314 | Mediastinal mass | FAERS: 1 | US FAERS | |
| 315 | Medication residue present | FAERS: 1 | US FAERS | |
| 316 | Meningitis | FAERS: 1 | US FAERS | |
| 317 | Mental Fatigue | FAERS: 1 | US FAERS | |
| 318 | Mental impairment | FAERS: 1 | US FAERS | |
| 319 | Migraine with Aura | FAERS: 1 | US FAERS | |
| 320 | Muscle strain | FAERS: 1 | US FAERS | |
| 321 | Musculoskeletal discomfort | FAERS: 1 | US FAERS | |
| 322 | Mycobacterium tuberculosis complex test positive | FAERS: 1 | US FAERS | |
| 323 | Myelitis | FAERS: 1 | US FAERS | |
| 324 | Neonatal aspiration | FAERS: 1 | US FAERS | |
| 325 | Neonatal respiratory failure | FAERS: 1 | US FAERS | |
| 326 | Nephritis | FAERS: 1 Canada Vigilance: 2 | Canada Vigilance US FAERS | |
| 327 | Nephroblastoma | FAERS: 1 | US FAERS | |
| 328 | Night sweats | FAERS: 1 | US FAERS | |
| 329 | No adverse event | FAERS: 1 | US FAERS | |
| 330 | Nocturia | FAERS: 1 | US FAERS | |
| 331 | Obesity | FAERS: 1 | US FAERS | |
| 332 | Obsessive-Compulsive Disorder | FAERS: 1 | US FAERS | |
| 333 | Oophoritis | FAERS: 1 | US FAERS | |
| 334 | Oral mucosal eruption | FAERS: 1 | US FAERS | |
| 335 | Oral pain | FAERS: 1 | US FAERS | |
| 336 | Oropharyngeal discomfort | FAERS: 1 | US FAERS | |
| 337 | Osteomyelitis | FAERS: 1 | US FAERS | |
| 338 | Otitis Media | FAERS: 1 | US FAERS | |
| 339 | Pancreatic enzymes increased | FAERS: 1 | US FAERS | |
| 340 | Patient uncooperative | FAERS: 1 | US FAERS | |
| 341 | Peptic Ulcer | FAERS: 1 | US FAERS | |
| 342 | Peripheral swelling | FAERS: 1 | US FAERS | |
| 343 | Personality Change | FAERS: 1 | US FAERS | |
| 344 | Petechiae | FAERS: 1 | US FAERS | |
| 345 | Pharyngitis bacterial | FAERS: 1 | US FAERS | |
| 346 | Photophobia | FAERS: 1 | US FAERS | |
| 347 | Polyuria | FAERS: 1 | US FAERS | |
| 348 | Poor dental condition | FAERS: 1 | US FAERS | |
| 349 | Poor peripheral circulation | FAERS: 1 | US FAERS | |
| 350 | Pre-Eclampsia | FAERS: 1 | US FAERS | |
| 351 | Prescribed overdose | FAERS: 1 | US FAERS | |
| 352 | Product packaging issue | FAERS: 1 | US FAERS | |
| 353 | Product storage error | FAERS: 1 | US FAERS | |
| 354 | Protein total abnormal | FAERS: 1 | US FAERS | |
| 355 | Protein total increased | FAERS: 1 | US FAERS | |
| 356 | Psychiatric symptom | FAERS: 1 | US FAERS | |
| 357 | Pyloric Stenosis | FAERS: 1 | US FAERS | |
| 358 | Renal pain | FAERS: 1 | US FAERS | |
| 359 | Respiratory Failure | FAERS: 1 | US FAERS | |
| 360 | Respiratory arrest | FAERS: 1 | US FAERS | |
| 361 | Retinopathy of Prematurity | FAERS: 1 | US FAERS | |
| 362 | Rhinitis | FAERS: 1 | US FAERS | |
| 363 | Rotator cuff syndrome | FAERS: 1 | US FAERS | |
| 364 | Salpingo-oophorectomy unilateral | FAERS: 1 | US FAERS | |
| 365 | Scarlet Fever | FAERS: 1 | US FAERS | |
| 366 | Schizencephaly | FAERS: 1 | US FAERS | |
| 367 | Screaming | FAERS: 1 | US FAERS | |
| 368 | Separation Anxiety Disorder | FAERS: 1 | US FAERS | |
| 369 | Serotonin Syndrome | FAERS: 1 | US FAERS | |
| 370 | Serum serotonin decreased | FAERS: 1 | US FAERS | |
| 371 | Shoulder Dystocia | FAERS: 1 | US FAERS | |
| 372 | Sinus operation | FAERS: 1 | US FAERS | |
| 373 | Skin Erosion | FAERS: 1 | US FAERS | |
| 374 | Skin irritation | FAERS: 1 | US FAERS | |
| 375 | Staring | FAERS: 1 | US FAERS | |
| 376 | Stillbirth | FAERS: 1 | US FAERS | |
| 377 | Stomatitis | FAERS: 1 | US FAERS | |
| 378 | Subcutaneous Abscess | FAERS: 1 | US FAERS | |
| 379 | Suicide attempt | FAERS: 1 | US FAERS | |
| 380 | Sunburn | FAERS: 1 | US FAERS | |
| 381 | Tachycardia | FAERS: 1 | US FAERS | |
| 382 | Tension | FAERS: 1 | US FAERS | |
| 383 | Tetany | FAERS: 1 | US FAERS | |
| 384 | Therapy cessation | FAERS: 1 | US FAERS | |
| 385 | Thyroid hormones decreased | FAERS: 1 | US FAERS | |
| 386 | Tongue eruption | FAERS: 1 | US FAERS | |
| 387 | Tonic clonic movements | FAERS: 1 | US FAERS | |
| 388 | Tonsillectomy | FAERS: 1 | US FAERS | |
| 389 | Tooth Extraction | FAERS: 1 | US FAERS | |
| 390 | Tooth delamination | FAERS: 1 | US FAERS | |
| 391 | Trismus | FAERS: 1 | US FAERS | |
| 392 | Unevaluable investigation | FAERS: 1 | US FAERS | |
| 393 | Upper respiratory tract congestion | FAERS: 1 | US FAERS | |
| 394 | Upper-airway cough syndrome | FAERS: 1 | US FAERS | |
| 395 | White blood cell count decreased | FAERS: 1 | US FAERS | |
| 396 | Wrong patient received medication | FAERS: 1 | US FAERS | |
| 397 | Wrong technique in drug usage process | FAERS: 1 | US FAERS | |
| 398 | effusion | FAERS: 1 | US FAERS | |
| 399 | furuncle | FAERS: 1 | US FAERS | |
| 400 | nervous system disorder | FAERS: 1 | US FAERS | |
| 401 | Autistic Disorder | 16160627 | CTD | |
| 402 | Brain Diseases | 1389541 | CTD | |
| 403 | Cardiovascular Diseases | 20610621 | CTD |
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