2015-04-16 - Male - 33 Years old
900314509
| Adverse reaction report number | 900314509 |
| Latest AER version number | 1 |
| Market authorization holder AER number | CA201503148 |
| Initial received date | 2015-04-16 |
| Latest received date | 2015-07-22 |
| Age | 33 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| 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 | 60 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| BUPRENORPHINE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE | Concomitant | Unknown | Drug dependence | ||||
| XANAX | TABLET | Concomitant | Unknown | Anxiety |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Asthenia | |
| Depression | |
| Drug tolerance | |
| Fatigue | |
| Hypernatraemia | |
| Hypersomnia | |
| Impaired work ability | |
| Lethargy | |
| Overdose | |
| Panic attack | |
| Peripheral swelling | |
| Product dose omission | |
| Weight increased | |
| Withdrawal syndrome | |