2009-02-24 - Female - 39 Years old
319147
| Adverse reaction report number | 319147 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SPV1200900195 |
| Initial received date | 2009-02-24 |
| Latest received date | 2009-02-24 |
| Age | 39 Years |
| Gender | Female |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Physician |
| 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 15MG | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 15 Milligram | 1 every 1 Day(s) | 631 Day(s) | Attention deficit/hyperactivity disorder |
| ADDERALL XR 30MG | CAPSULE, EXTENDED RELEASE | Suspect | Unknown | 30 Milligram | 1 every 1 Day(s) | 631 Day(s) | Attention deficit/hyperactivity disorder |
| AERIUS | NOT SPECIFIED | Concomitant | Unknown | ||||
| ASA | NOT SPECIFIED | Concomitant | Unknown | ||||
| CITALOPRAM | TABLET | Concomitant | Unknown | ||||
| METFORMIN | TABLET | Concomitant | Unknown | ||||
| SYNTHROID | NOT SPECIFIED | Concomitant | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Granulomatosis with polyangiitis | |
| Limb discomfort | |
| Nasal septum perforation | |
| Pain | |
| Paranasal sinus discomfort | |
| Prescribed overdose | |
| Raynaud's phenomenon | |
| Soft tissue disorder | |
| Vasculitis | |