2018-01-17 - Unknown
901682421
| Adverse reaction report number | 901682421 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201729366 |
| Initial received date | 2018-01-17 |
| Latest received date | 2018-01-17 |
| Age | N/A |
| Gender | Unknown |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Unknown |
| Serious report? | Yes |
Reason for seriousness
| Death | |
| Disability | |
| Cogenital anomaly | |
| Life threateting | |
| Hospitalization | |
| Other medically important | Yes |
| Product description | Dosage form | Health product role | Route of administration | Dose | Frequency | Therapy duration | Indication(s) |
|---|---|---|---|---|---|---|---|
| ADDERALL XR | CAPSULE | Suspect | Unknown | 30 Milligram | 3 every 1 Day(s) | Product used for unknown indication | |
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 30 Milligram | 2 every 1 Day(s) | Product used for unknown indication |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Dependence | |
| Off label use | |
| Prescribed overdose | |