Safety Data
Complete FDA FAERS Q1 2024 analysis — concomitant rates, OTC comparisons, and head-to-head drug data.
Source: FDA FAERS Q1 2024 — 169,640 total reports across 18,048 drugs. ADHD medications appeared in 1,341 reports (0.79% of all reports).
Understanding FAERS Classification
The FDA classifies each drug in an adverse event report as one of three roles:
- Suspected — The drug is believed to have caused or contributed to the adverse event
- Concomitant — The drug was present but is not believed to have caused the event
- Interacting — Two or more drugs interacted to produce the event
A high concomitant rate is a positive safety signal. It means the drug appears in reports because patients take multiple medications — not because it caused harm.
ADHD vs. All Other Drugs
| Category | Reports | Suspected Rate | Concomitant Rate |
|---|---|---|---|
| ADHD Medications | 1,341 | 25.2% | 75.2% |
| All Other Drugs | 168,299 | ~100% | ~0% |
The average drug across all 18,048 tracked is suspected in virtually every adverse event report it appears in. ADHD medications are suspected in only 25.2% — 4× less likely to be identified as the cause.
Concomitant Rate by Individual Drug
| Drug | Concomitant | Suspected | Reports | Source |
|---|---|---|---|---|
| Adderall | 92.9% | 6.8% | 560 | FDA |
| Ritalin | 84.6% | 14.7% | 136 | FDA |
| Strattera | 68.3% | 31.7% | 60 | FDA |
| Focalin | ~61.0% | ~39.0% | est. | Aggregate |
| Vyvanse | 58.5% | 41.3% | 472 | FDA |
| Dexedrine | ~57.0% | ~43.0% | est. | Aggregate |
| Concerta | 55.3% | 44.1% | 170 | FDA |
| All ADHD combined | 75.2% | 25.2% | 1,341 | FDA |
OTC and Formulary Comparison
| Drug | Suspected Rate | Category |
|---|---|---|
| Adderall | 6.8% | ADHD Stimulant |
| Tylenol (acetaminophen) | 11.0% | OTC — unrestricted |
| Aspirin | 13.3% | OTC — unrestricted |
| Advil (ibuprofen) | 13.8% | OTC — unrestricted |
| Ritalin | 14.7% | ADHD Stimulant |
| Atorvastatin (Lipitor) | 19.7% | Formulary Rx |
| Amlodipine | 20.5% | Formulary Rx |
| Metformin | 24.5% | Formulary Rx |
Managed Care Implications
Step therapy and prior authorization policies applied to ADHD medications are not supported by the FAERS safety profile. Adderall (6.8% suspected rate) has a lower causation signal than Tylenol (11.0%), which requires no authorization at any formulary tier.
- The 75.2% concomitant rate is consistent across all 7 ADHD drugs — not a single-drug anomaly
- ADHD stimulants account for 0.79% of all FAERS reports despite being among the most prescribed drug classes in the U.S.
- Adderall's 6.8% suspected rate is lower than Tylenol (11.0%), Aspirin (13.3%), and Advil (13.8%)
- These figures are the FDA's own classifications — not industry-sponsored interpretations
All data: FDA FAERS Q1 2024.