2005-09-07 - Male
190158
| Adverse reaction report number | 190158 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SUS1200500656 |
| Initial received date | 2005-09-07 |
| Latest received date | 2005-09-07 |
| Age | N/A |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| Source of report | MAH |
| Report outcome | Recovered/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 | Oral | Once | |||
| BENADRYL | NOT SPECIFIED | Drug used to treat AE |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Dyspnoea | |
| Hypersensitivity | |
| Rash | |