2017-10-10 - Unknown
901521075
| Adverse reaction report number | 901521075 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201725150 |
| Initial received date | 2017-10-10 |
| Latest received date | 2017-10-10 |
| 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 | Suspect | Unknown | 15 Milligram | Attention deficit/hyperactivity disorder | ||
| ADDERALL XR | CAPSULE | Suspect | Unknown | 20 Milligram | Attention deficit/hyperactivity disorder | ||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 10 Milligram | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Abnormal behaviour | |
| Adverse drug reaction | |
| Drug ineffective | |