2005-11-24 - Male - 9 Years old
192691
| Adverse reaction report number | 192691 |
| Latest AER version number | 0 |
| Market authorization holder AER number | SUS1200500836 |
| Initial received date | 2005-11-24 |
| Latest received date | 2005-11-24 |
| Age | 9 Years |
| Gender | Male |
| Weight | N/A |
| Type of report | Spontaneous |
| Reporter type | Consumer Or Other Non Health Professional |
| Source of report | MAH |
| Report outcome | Recovered/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 | CAPSULE, EXTENDED RELEASE | Suspect | Oral | 10 Milligram | 1 every 1 Day(s) | ||
| BENADRYL | NOT SPECIFIED | Concomitant | Unknown | ||||
| BENADRYL CHILDRENS LIQUID 6.25MG/5ML | LIQUID ORAL | Drug used to treat AE | Unknown | ||||
| TYLENOL | NOT SPECIFIED | Drug used to treat AE | Unknown | ||||
| ZOVIRAX | NOT SPECIFIED | Drug used to treat AE | Unknown |
| MedDRA version: v.21.1 | |
| Adverse reaction terms | Reaction duration |
|---|---|
| Dyspnoea | |
| Headache | |
| Hypersensitivity | |
| Oedema | |
| Oropharyngeal pain | |
| Rash | |