2015-09-03 - Female - 24 Years old
900464936
| Adverse reaction report number | 900464936 |
| Latest AER version number | 0 |
| Market authorization holder AER number | CA201510567 |
| Initial received date | 2015-09-03 |
| Latest received date | 2015-09-03 |
| Age | 24 Years |
| Gender | Female |
| 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 | Oral | 30 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder | |
| ADDERALL XR | CAPSULE | Suspect | Oral | 1 Year(s) | Attention deficit/hyperactivity disorder | ||
| ADDERALL XR | CAPSULE | Suspect | Oral | Attention deficit/hyperactivity disorder | |||
| ADDERALL XR | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 20 Milligram | 1 every 1 Day(s) | Attention deficit/hyperactivity disorder |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Anxiety | |
| Disturbance in attention | |
| Drug ineffective | |
| Dyspnoea | |
| Headache | |
| Insomnia | |
| Mood swings | |
| Prescribed overdose | |
| Product dose omission | |
| Tic | |