Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123181984 | 12318198 | 4 | F | 20160915 | 20160429 | 20160929 | EXP | PHEH2016US010471 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160929 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123181984 | 12318198 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER DOSE: 8 MG THRICE DAILY | D | 20103 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123181984 | 12318198 | 1 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123181984 | 12318198 | CA |
| 123181984 | 12318198 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123181984 | 12318198 | Anhedonia | |
| 123181984 | 12318198 | Anxiety | |
| 123181984 | 12318198 | Blepharitis | |
| 123181984 | 12318198 | Brain injury | |
| 123181984 | 12318198 | Cardiac murmur | |
| 123181984 | 12318198 | Cardiac ventricular disorder | |
| 123181984 | 12318198 | Cardiomegaly | |
| 123181984 | 12318198 | Cerebral atrophy | |
| 123181984 | 12318198 | Cerebral palsy | |
| 123181984 | 12318198 | Cerebral ventricle dilatation | |
| 123181984 | 12318198 | Congenital anomaly | |
| 123181984 | 12318198 | Constipation | |
| 123181984 | 12318198 | Deformity | |
| 123181984 | 12318198 | Developmental delay | |
| 123181984 | 12318198 | Diplegia | |
| 123181984 | 12318198 | Drooling | |
| 123181984 | 12318198 | Dyspnoea | |
| 123181984 | 12318198 | Emotional distress | |
| 123181984 | 12318198 | Eye irritation | |
| 123181984 | 12318198 | Foetal exposure during pregnancy | |
| 123181984 | 12318198 | Gait disturbance | |
| 123181984 | 12318198 | Haematemesis | |
| 123181984 | 12318198 | Hypoxic-ischaemic encephalopathy | |
| 123181984 | 12318198 | Injury | |
| 123181984 | 12318198 | Joint dislocation | |
| 123181984 | 12318198 | Language disorder | |
| 123181984 | 12318198 | Left-to-right cardiac shunt | |
| 123181984 | 12318198 | Microcephaly | |
| 123181984 | 12318198 | Mitral valve incompetence | |
| 123181984 | 12318198 | Muscle tone disorder | |
| 123181984 | 12318198 | Ocular hyperaemia | |
| 123181984 | 12318198 | Pain | |
| 123181984 | 12318198 | Pancreatitis | |
| 123181984 | 12318198 | Precocious puberty | |
| 123181984 | 12318198 | Pyrexia | |
| 123181984 | 12318198 | Quadriparesis | |
| 123181984 | 12318198 | Quadriplegia | |
| 123181984 | 12318198 | Respiratory arrest | |
| 123181984 | 12318198 | Respiratory distress | |
| 123181984 | 12318198 | Scoliosis | |
| 123181984 | 12318198 | Seborrhoea | |
| 123181984 | 12318198 | Seizure | |
| 123181984 | 12318198 | Selective eating disorder | |
| 123181984 | 12318198 | Self esteem decreased | |
| 123181984 | 12318198 | Sleep apnoea syndrome | |
| 123181984 | 12318198 | Speech disorder | |
| 123181984 | 12318198 | Strabismus | |
| 123181984 | 12318198 | Subdural haematoma | |
| 123181984 | 12318198 | Transposition of the great vessels | |
| 123181984 | 12318198 | Tricuspid valve incompetence | |
| 123181984 | 12318198 | Upper airway obstruction | |
| 123181984 | 12318198 | Ventricular hypertrophy | |
| 123181984 | 12318198 | Ventricular septal defect | |
| 123181984 | 12318198 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |