2018-07-17 - Unknown
902014486
| Adverse reaction report number | 902014486 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201825971 |
| Initial received date | 2018-07-17 |
| Latest received date | 2018-07-17 |
| Age | N/A |
| Gender | Unknown |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| Source of report | MAH |
| Report outcome | Unknown |
| 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 | Unknown | 40 Milligram | 1 every 1 Day(s) | Narcolepsy | |
| LUNESTA | TABLET | Concomitant | Product used for unknown indication |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Anxiety disorder | |
| Drug ineffective | |
| Off label use | |