2018-03-05 - Female - 38 Years old
710078
| Adverse reaction report number | 710078 |
| Latest AER version number | 0 |
| Market authorization holder AER number | N/A |
| Initial received date | 2018-03-05 |
| Latest received date | 2018-03-05 |
| Age | 38 Years |
| Gender | Female |
| Weight | 86 Kilograms |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | Hospital |
| Report outcome | Not recovered/not resolved |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | Yes |
| Cogenital anomaly | |
| Life threateting | Yes |
| Hospitalization | Yes |
| Other medically important |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR 10MG MIXED SALTS AMPHETAMINE | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 1 every 1 Day(s) | Disturbance in attention | ||
| ADDERALL XR 30MG MIXED SALTS AMPHETAMINE | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 1 every 1 Day(s) | Disturbance in attention | ||
| BUPROPION SR | TABLET (EXTENDED-RELEASE) | Concomitant | |||||
| LAMOTRIGINE | TABLET | Concomitant | |||||
| TYLENOL #3 (ACETAMINOPHEN/CODEINE) | TABLET | Concomitant | |||||
| VALACYCLOVIR | NOT SPECIFIED | Concomitant |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Ataxia | |
| Blood pressure abnormal | |
| Brain stem infarction | |
| Cerebellar infarction | |
| Cerebrovascular accident | |
| Cognitive disorder | |
| Headache | |
| Heart rate abnormal | |
| Intracranial artery dissection | |
| Nausea | |
| Neck pain | |
| Vascular pseudoaneurysm | |
| White blood cell disorder | |