OpenFDA.

Multi-use Website

June 11, 2014

US Food and Drug Administration; FDA.

This Web site provides access to large publicly available datasets for adverse drug events to enable developers, researchers, and consumers to use this information when designing medication safety improvement plans or projects. Planned updates to this site include data on recalls and product documentation.

Available at

Related Resources From the Same Author(s)

FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration.

April 8, 2020

Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip).

June 22, 2011

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.

March 3, 2010

Wear face masks with no metal during MRI exams.

December 16, 2020

Infections associated with reprocessed flexible bronchoscopes.

September 30, 2015

FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients.

March 11, 2015

Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.

March 4, 2015

FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved.

January 13, 2016

Five Medication Safety Tips for Older Adults.

February 15, 2024

Be an Active Member of Your Health Care Team.

May 21, 2014

Lock it Up: Medicine Safety in Your Home.

November 30, 2011

BeSafeRx: Know Your Online Pharmacy.

October 10, 2012

Teaching Kids About Using Medicine Safely.

February 29, 2012

Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

October 10, 2018

Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens.

April 8, 2009

FDA MedWatch and Patient Safety Tutorial.

December 10, 2008

FDA 101: How to Use the Consumer Complaint System and MedWatch.

June 25, 2008

Important information for the safe use of Tussionex Pennkinetic Extended-Release Suspension.

March 26, 2008

Promethazine HCl (marketed as Phenergan) Information.

May 3, 2006

Benzocaine sprays marketed under different names, including Hurricaine, Topex, and Cetacaine.

February 22, 2006

Medicines in My Home.

August 2, 2006

Bar Code Label Requirements for Blood and Blood Components.

April 26, 2006

Interference between CT and Electronic Medical Devices.

July 30, 2008

FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).

June 3, 2015

New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients.

September 29, 2010

SmartTots.

April 13, 2011

Serious medication errors from intravenous administration of nimodipine oral capsules.

August 11, 2010

Shelhigh, Inc. implantable medical devices.

May 2, 2007

FDA Patient Safety News. A Video News Show for Health Professionals.

March 6, 2005

MedWatch E-list.

March 6, 2005

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.

January 13, 2021

Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry.

December 23, 2020

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry.

May 25, 2022

Medication Safety During the COVID-19 Pandemic: What Have We Learned in the United States.

June 23, 2020

My Medicines.

July 9, 2014

Safety Considerations for Product Design to Minimize Medication Errors: Guidance for Industry.

January 9, 2013

Postmarket Drug Safety Information for Patients and Providers.

November 19, 2008

Questions and Answers on FDA's Adverse Event Reporting System (FAERS).

September 17, 2008

Drug Shortages: Root Causes and Potential Solutions.

November 13, 2019

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

June 2, 2021

Using ventilator splitters during the COVID-19 pandemic--letter to health care providers.

February 17, 2021

Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors.

January 13, 2016

Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.

March 4, 2015

Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.

August 5, 2015

FDA public health notification: unretrieved device fragments.

January 30, 2008

Human Factors and Medical Devices.

March 27, 2005

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder.

August 5, 2020

Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings.

February 17, 2021

Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling.

February 10, 2021

FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only.

February 3, 2021

Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling.

May 19, 2021

Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication.

October 20, 2021

Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers.

November 11, 2020

FDA advises health care professionals and patients about insulin pen packaging and dispensing.

October 28, 2020

FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing.

February 24, 2022 - February 24, 2022

Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11.

September 1, 2021

Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death.

August 11, 2021

FDA alerts health care professionals to the temporary absence of warning statement on the vial caps of two neuromuscular blocking agents.

July 15, 2020

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up.

October 19, 2022

Use duodenoscopes with innovative designs to enhance safety: FDA Safety Communication.

May 4, 2022

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff.

October 3, 2022

Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions.

January 25, 2017

FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).

August 12, 2015

Letter to Health Care Providers: Safe Use of Surgical Staplers and Staples.

October 7, 2021

FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy.

August 20, 2021

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.

April 17, 2019

Maalox Total Relief and Maalox Liquid Products: Medication Use Errors.

March 3, 2010

Relenza (zanamivir) inhalation powder.

October 21, 2009

Potentially fatal errors with GDH-PQQ [glucose dehydrogenase pyrroloquinoline quinone] glucose monitoring technology.

October 21, 2009

Tamiflu (oseltamivir) for oral suspension: potential medication errors.

October 7, 2009

Hydrocodone bitartrate and acetaminophen tablets, phenobarbital tablets by Qualitest: recall—incorrect package labeling.

February 16, 2011

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose.

January 19, 2011

Drug Shortages.

April 27, 2011

FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death.

October 9, 2013

Making Medical Devices Safer at Home.

January 9, 2013

Important change to heparin container labels to clearly state the total drug strength.

December 19, 2012

Kadcyla (ado-trastuzumab emtansine): drug safety communication—potential medication errors resulting from name confusion.

May 15, 2013

Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events.

August 15, 2012

Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume.

May 30, 2012

Safety Problems With Your Child's Medical Device?

July 31, 2013

Reprocessing of Reusable Medical Devices.

January 11, 2012

A Review of FDA’s Approach to Medical Product Shortages.

November 16, 2011

Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays.

November 7, 2012

Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death.

February 20, 2013

Accidental exposures to fentanyl patches continue to be deadly to children.

July 21, 2021

Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

June 6, 2018

FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.

November 28, 2018

FDA Safety Communication: recommendations to reduce surgical fires and related patient injury.

June 20, 2018

FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.

February 7, 2018

FDA Funding Available for Research Aimed at Reducing Preventable Harm from Medication

November 6, 2019

ReliOn insulin syringes for use with U-100 insulin (Tyco Healthcare-Covidien).

November 19, 2008

Heparin sodium injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL medication errors.

February 21, 2007

Fentanyl transdermal system (marketed as Duragesic) information.

July 10, 2015

Nimodipine Capsules (marketed as Nimotop).

March 1, 2006

Important Warnings and Instructions for Heparin Sodium Injection (Baxter).

February 20, 2008

Public Health Notification from FDA: Vail Products Enclosed Bed Systems.

December 19, 2007

An Introduction to the Improved FDA Prescription Drug Labeling.

November 1, 2006

Roxane Laboratories initiates a nationwide voluntary recall of a single manufacturing lot of Azathioprine tablets in the U.S. and Puerto Rico.

July 26, 2006

MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

June 22, 2005

FDA and ISMP Lists of Look-Alike Drug Names With Recommended Tall Man Letters.

January 26, 2023

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Patient safety informatics: meeting the challenges of emerging digital health.

July 20, 2022

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry.

May 25, 2022

Accidental exposures to fentanyl patches continue to be deadly to children.

July 21, 2021

Identifying health information technology usability issues contributing to medication errors across medication process stages.

July 7, 2021

FDA Advise-ERR: reported medication errors with Veklury (remdesivir) emergency use authorization.

September 23, 2020

Role of artificial intelligence in patient safety outcomes: systematic literature review.

August 26, 2020

Care Compare.

July 1, 2020

Patient Safety Movement Foundation.

June 2, 2020

FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration.

April 8, 2020

Is one-pen, one-patient achievable in the hospital? A quality improvement project to reduce risks of inadvertent insulin pen sharing at a large academic medical center.

January 29, 2020

The contribution of staffing to medication administration errors: a text mining analysis of incident report data.

December 18, 2019

Get the Medications Right Institute.

August 7, 2019

Intravenous infusion administration: a comparative study of practices and errors between the United States and England and their implications for patient safety.

July 10, 2019

Accuracy of a popular online symptom checker for ophthalmic diagnoses.

May 22, 2019

Governing the safety of artificial intelligence in healthcare.

May 8, 2019

Consumer-directed technologies to improve medication management and safety.

April 24, 2019

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.

April 17, 2019

Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again.

March 20, 2019

The impact of technology on safe medicines use and pharmacy practice in the US.

January 30, 2019

A web application to involve patients in the medication reconciliation process: a user-centered usability and usefulness study.

December 19, 2018

FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.

November 28, 2018

Diagnostic Excellence Initiative.

November 7, 2018

Making Hospitals Safe for People With Diabetes.

October 31, 2018

Wiser Healthcare.

October 24, 2018

U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.

April 11, 2018

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