AI-powered analysis of FDA adverse event reports. Search any medication. Understand the real risks. Know before you take.
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85/100 · Critical
29,564 FDA reports
Abacavir Sulfate Adverse Events: High Serious Reaction Rate
35/100 · Moderate
58,437 FDA reports
Abaloparatide Adverse Events: Mild to Moderate Common Reactions
78/100 · Elevated
665,237 FDA reports
Abatacept Adverse Events: High Seriousness and Diverse Reactions
78/100 · Elevated
35,479 FDA reports
Abemaciclib Adverse Events: High Incidence of Gastrointestinal and Hematological Reactions
72/100 · Elevated
56,299 FDA reports
High Fatigue and Prostate Cancer-Related Reactions with Abiraterone Acetate
78/100 · Elevated
15,655 FDA reports
High Serious Event Rate for Acalabrutinib: Death and Malignant Neoplasms
35/100 · Moderate
1,089,938 FDA reports
Acetaminophen Safety Profile: Common Mild Reactions, Serious Cases Not Frequent
65/100 · Elevated
211 FDA reports
Moderate Safety Concerns with Acetaminophen 325 mg
65/100 · Elevated
383 FDA reports
Moderate Safety Concerns with Acetaminophen 325mg
65/100 · Elevated
253 FDA reports
Moderate Safety Concerns with Acetaminophen 500 MG
85/100 · Critical
734,137 FDA reports
Acetaminophen 500mg: High Serious Reaction Rate and Diverse Safety Concerns
85/100 · Critical
113,152 FDA reports
High Seriousness and Diverse Reactions for Acetaminophen and Codeine
85/100 · Critical
3,182 FDA reports
High Safety Concerns with Acetaminophen and Codeine Phosphate
72/100 · Elevated
10,191 FDA reports
Moderate Safety Concerns with Acetaminophen and Diphendramine Hydrochloride
45/100 · Moderate
299 FDA reports
Mixed Safety Profile for Acetaminophen and Ibuprofen
65/100 · Elevated
51 FDA reports
Moderate Safety Concerns with Acetaminophen and Phenylephrine Hydrochloride
25/100 · Low Risk
37,042 FDA reports
Most Common Reactions Include Headache and Nausea; Serious Reactions Are Not Frequent
The FDA Adverse Event Reporting System (FAERS) is one of the most important post-market surveillance tools in the United States. After a drug receives FDA approval through clinical trials, FAERS serves as the primary mechanism for tracking real-world safety outcomes across millions of patients. Healthcare professionals, consumers, and drug manufacturers submit reports of adverse events, medication errors, and product quality complaints to this database, creating a comprehensive record of drug safety signals that emerges only after widespread use.
ReadTheSideEffect transforms this raw data into actionable intelligence. Our AI analyzes millions of FAERS reports to calculate safety scores, identify the most commonly reported side effects for each medication, and generate plain-English summaries that make complex pharmacovigilance data accessible to everyone. Whether you are a patient researching a new prescription, a healthcare provider reviewing safety profiles, or a researcher studying adverse event patterns, our platform provides the data-driven insights you need.
Clinical trials that lead to FDA drug approval typically involve a few thousand participants over a limited time period. Many important safety signals only emerge after a drug reaches the broader market and is used by millions of people with diverse medical histories, genetic backgrounds, and co-administered medications. FAERS captures these post-market signals, enabling regulators to identify risks that clinical trials could not detect.
Adverse event reports have led to critical safety actions including black box warnings, dosage modifications, contraindication updates, and in some cases, full market withdrawals. The voluntary nature of FAERS reporting means that actual adverse event rates may be higher than what the database reflects. Despite this limitation, the sheer volume of data, with millions of reports accumulated over decades, makes FAERS an invaluable resource for understanding medication safety in real-world populations.
Every report in the FAERS database represents a real patient experience. By analyzing these reports at scale with AI, ReadTheSideEffect helps surface patterns that might otherwise remain buried in millions of records, giving patients and providers a clearer picture of drug safety.
Each drug on ReadTheSideEffect receives a safety score from 0 to 100, calculated by our AI models based on multiple factors extracted from FAERS data. The scoring algorithm considers the total volume of adverse event reports relative to estimated prescribing volume, the proportion of serious versus non-serious outcomes, hospitalization and mortality rates mentioned in reports, the diversity and severity of reported reactions, and temporal trends in reporting patterns.
A lower safety score indicates that a drug has fewer or less severe adverse event reports relative to its usage, while a higher score suggests a greater volume or severity of reported adverse events. It is critical to understand that these scores reflect reporting patterns in FAERS and are not clinical efficacy or safety ratings. Many factors influence adverse event reporting, including the seriousness of the condition being treated, the size of the patient population, media attention, and regulatory actions. Always discuss your medications with your healthcare provider.
FAERS is a database maintained by the U.S. Food and Drug Administration that contains reports of adverse events, medication errors, and product quality complaints for drugs and therapeutic biological products. Healthcare professionals, consumers, and manufacturers can submit reports. FAERS helps the FDA monitor drug safety after products reach the market.
ReadTheSideEffect uses artificial intelligence to process millions of FDA adverse event reports from the FAERS database. Our AI models calculate safety scores, identify patterns in reported side effects, analyze severity distributions, and generate plain-English summaries that make complex safety data accessible to patients and healthcare professionals.
Each drug receives a safety score from 0 to 100 based on the volume and severity of FDA adverse event reports. A lower score indicates fewer or less severe reported adverse events relative to the drug's usage. Scores are calculated using report volume, serious outcome rates, hospitalization frequency, and other FAERS data points. These scores are informational tools, not clinical assessments.
No. ReadTheSideEffect provides informational summaries of publicly available FDA data and should never replace professional medical advice. Adverse event reports do not prove that a drug caused a side effect. Always consult your healthcare provider before starting, stopping, or changing any medication.
You can report adverse events to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Reports can be submitted online at fda.gov/medwatch, by phone at 1-800-FDA-1088, or by mail using FDA Form 3500. Healthcare professionals are encouraged to report serious adverse events, and consumers can report any suspected side effects.
ReadTheSideEffect regularly ingests the latest data from the openFDA API, which provides access to FDA datasets including FAERS. Our AI enrichment process runs on newly ingested data to keep safety scores, side effect profiles, and analysis current. Each drug page shows its last updated date.
A side effect is any unintended effect of a medication, whether harmful or not. An adverse event is any undesirable experience associated with using a medical product, reported to the FDA. Not all adverse events are caused by the drug; they may be related to underlying conditions, other medications, or coincidental timing. FAERS reports capture associations, not proven causation.