2012-11-06 - Male
478825
| Adverse reaction report number | 478825 |
| Latest AER version number | 0 |
| Market authorization holder AER number | 2012273460 |
| Initial received date | 2012-11-06 |
| Latest received date | 2012-11-06 |
| Age | N/A |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Pharmacist |
| Source of report | MAH |
| Report outcome | Not recovered/not resolved |
| 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, EXTENDED RELEASE | Suspect | Unknown | Product used for unknown indication | |||
| CHAMPIX | TABLET | Suspect | Unknown | Product used for unknown indication | |||
| CHAMPIX | TABLET | Suspect | Unknown | Smoking cessation therapy |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug ineffective | |
| Drug interaction | |
| Drug level changed | |
| Lip and/or oral cavity cancer | |