28/10/2025
Interested in ADHD medication?
The FDA Adverse Event Reporting System (FAERS) is an information database that holds reports about adverse effects and medication errors, that have been submitted to the FDA.
Wu et al, 2025 conducted an analysis using the FAERS data from 2004 to 2023. They included the reports in relation to the most commonly prescribed medications for ADHD: Methylphenidate, Atomoxetine, and Amphetamine.
72,298 reports were made in relation to the 3 drugs, describing adverse effects.
37,471 linked to methylphenidate (24.15% aged 6-12), 17,335 to atomoxetine (31.79% age 6-12), and 17,492 to amphetamine (43.52% aged 19+).
It is believed only 1 to 10% of serious adverse events are actually reported (Nisssen, 2006) as it isn’t compulsory to report these, it is a voluntary system so the numbers may be much higher.
The main adverse effects of methylphenidate, atomoxetine, and amphetamine were related to what was described as “psychiatric disorders”, with the most common manifestations including aggression, abnormal behaviour, and restlessness. They found a significant association between all three ADHD drugs and su***de related reactions. (The FDA warning indicates su***de ideation, risk of misuse, abuse and addiction on the box for atomoxetine).
Mydriasis (dilation of the pupil), trichotillomania (hair pulling), somnolence (sleepiness), application site erythema (redness where medication is applied) and
headaches were also associated with all three drugs.
Methylphenidate was significantly associated with coronary artery dissection, carotid artery dissection and precocious puberty.
Atomoxetine was significantly associated with testicular and pe**le lesions, and liver damage, requiring special attention.
Amphetamine was significantly associated with serious neurological adverse effects and cardiovascular effects.
Their analysis shows there were significant associations with both methylphenidate and atomoxetine and delayed growth. Atomoxetine and amphetamine were associated with anti social behaviour. The highest reports from methylphenidate and atomoxetine were in relation to children aged 6-12.
Limitations of the study are that the results were mainly from individuals in the US.
The data stored doesn’t state how long the individuals have been on the medication, any additional medication being consumed or the dosage being taken. Additional health needs are also not listed.
ADHD is a highly comorbid condition, other disorders are not always diagnosed at the same time as an ADHD diagnosis is received. Therefore we are potentially treating individuals with medication which may exacerbated other symptoms, if there are underlying difficulties (example, anxiety or depression).
This is just one study which highlights the complex nature of using ADHD medication.
This is not a critism of parents/ carers who choose to medicate their children. It’s an insight into the information that’s out there but not publicised as well as the information that promotes medication. Everyone should be provided more information to make an informed decision.
The equivalent of the FAERS in the UK is the yellow card scheme. For anyone wanting to look up UK reports.
Study link:
https://scholar.google.co.uk/scholar?hl=en&as_sdt=0%2C5&as_vis=1&q=faers+database+wu+et+al+adhd&btnG= =gs_qabs&t=1761637905931&u=%23p%3DH7PQwDG3p9UJ
