PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

Methodology & Data Sources

How we collect, process, and present medication information.

Data Sources

Every piece of information on PlainMeds comes from official, publicly available FDA databases. We use three primary sources, all retrieved via the openFDA API at open.fda.gov and FDA bulk download services:

  • FDA Drug Labels (SPL — Structured Product Labeling): The full official labeling that pharmaceutical manufacturers submit to the FDA. This is the same information your pharmacist reads, covering indications, dosage, warnings, contraindications, drug interactions, and adverse reactions. Source: FDA Structured Product Labeling Resources + NLM DailyMed.
  • FDA Adverse Event Reporting System (FAERS): Real-world reports of adverse events submitted by healthcare professionals, patients, and manufacturers. We use aggregated FAERS data to show which side effects are reported most frequently in post-market surveillance. Source: FDA FAERS Public Dashboard.
  • FDA Drug Enforcement Reports: Official recall and enforcement actions from the FDA. We track active recalls so users can check whether any of their medications have been affected. Source: FDA Recalls, Market Withdrawals, & Safety Alerts.

Processing Pipeline

We download FDA drug label data from the openFDA API and bulk data files. Our ETL pipeline:

  • Extracts structured sections from SPL XML files (warnings, indications, dosage, interactions)
  • Applies editorial plain-language simplification to translate complex medical language into plain English
  • Joins drug records with FAERS adverse event counts by application number
  • Links active recall records to drug entries where matching brand or generic names are found
  • Indexes all drugs by brand name, generic name, and active ingredient for search

The AI simplification process is used for plain-language summaries only. All factual content — warnings, dosages, contraindications — is taken directly from official FDA labeling without modification.

FAERS Data Interpretation

FAERS adverse event reports are submitted voluntarily and represent reports received by the FDA, not confirmed causal relationships. The presence of a drug in FAERS reports does not mean the drug caused the reported event. FAERS data is used for hypothesis generation and signal detection, not to establish drug safety conclusions. Reporting rates may be influenced by media attention, drug popularity, and healthcare professional awareness.

Data Vintage and Update Frequency

FDA drug label data is updated continuously as manufacturers submit new or revised Structured Product Labeling to the FDA. The openFDA API reflects these submissions with minimal delay. FAERS adverse event data is published quarterly by the FDA, with each release covering the most recent complete quarter. Drug enforcement and recall data is updated as the FDA issues new enforcement actions. PlainMeds refreshes its database periodically to incorporate new drug labels, updated FAERS data, and current recall status.

Accuracy Commitment

PlainMeds reproduces FDA data exactly as published. All factual content — warnings, dosages, contraindications, drug interactions, and adverse event counts — is taken directly from official FDA databases without modification. The editorial plain-language simplification process is applied exclusively to generate plain-language summaries that make complex medical terminology more accessible. These summaries are clearly presented as aids to understanding, while the underlying factual data remains unchanged from the FDA source. When drug label data is unavailable or incomplete for a particular medication, this is displayed transparently rather than estimated.

Limitations

  • Drug label information may not reflect the most recent label revision if the manufacturer's updated SPL has not yet been processed by the FDA or the openFDA system. Always consult your pharmacist or prescriber for current prescribing information.
  • FAERS counts reflect reports received by the FDA, not the rate of adverse events per population of users. More widely prescribed medications will naturally accumulate more reports, regardless of their actual safety profile.
  • Our plain-language summaries are aids to understanding complex medical language, not substitutes for professional medical advice or the full official drug label.
  • Not all medications available on the US market are in the FDA SPL database. Some older drugs, compounded medications, and over-the-counter products may not appear or may have limited label data.
  • PlainMeds is not affiliated with the FDA or any government agency.

Important Disclaimer

This site is for informational purposes only and does not provide medical advice. Nothing on PlainMeds constitutes a recommendation to use, discontinue, or alter any medication. Always consult your doctor, pharmacist, or qualified healthcare provider before making any decisions about your medications.