2018-07-02 - Unknown
901987150
| Adverse reaction report number | 901987150 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201822865 |
| Initial received date | 2018-07-02 |
| Latest received date | 2018-07-02 |
| Age | N/A |
| Gender | Unknown |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Other Health Professional |
| Source of report | MAH |
| Report outcome | Not recovered/not resolved |
| Serious report? | No |
| 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 | Narcolepsy | ||
| VYVANSE | CAPSULE | Suspect | Oral | 20 Milligram | Narcolepsy | ||
| VYVANSE | CAPSULE | Suspect | Oral | 30 Milligram | Narcolepsy | ||
| VYVANSE | CAPSULE | Suspect | Oral | 60 Milligram | Narcolepsy |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Drug ineffective | |
| Dry throat | |
| Heart rate increased | |
| Nausea | |
| Off label use | |