2008-02-13 - Female - 18 Years old
302394
| Adverse reaction report number | 302394 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200800207 |
| Initial received date | 2008-02-13 |
| Latest received date | 2008-02-13 |
| Age | 18 Years |
| Gender | Female |
| 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 | Oral | 20 Milligram | 1 every 1 Day(s) | 6 Day(s) | |
| EFFEXOR NOS | NOT SPECIFIED | Concomitant | Unknown | ||||
| TETRACYCLINE | NOT SPECIFIED | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Discomfort | |
| Fatigue | |
| Heart rate increased | |
| Somnolence | |