The FDA’s Better Side Effects FAERS Database

The FDA's Better Side Effects FAERS Database
The FDA's Better Side Effects FAERS Database
Suzanne B. Robotti
Suzanne B. Robotti Executive Director

Now that the FDA has built a much more interactive FAERS database, you can search on a med you take and see what kinds of side effects others have reported.

How do you learn about the possible side effects of the drug your doctor has prescribed? First ask your doctor and pharmacist. Then check MedShadow to find out about side effects.

For even more information on side effects, you could go to the newly redesigned FAERS (Federal Adverse Events Reporting System) website.

FAERS is a compilation of unverified reports on side effects and adverse events (really bad side effects) from patients, family and doctors that started in the 1960s. Anyone can file a report by going online to the FAERS website — which means the information can be used as an indicator, but not as a fact. The website used to be a series of spreadsheets, and I found it impossible to use. The new website is a huge improvement on the old one. It gives data in simple charts and allows users to search particular drugs (but not the entire category of drugs).

You can use FAERS to find out what side effects actual other users are experiencing and to see for yourself the number of complaints on the drug. You cannot assume that you’ll experience the side effects reported, because they could be wrong. It’s very important to remember that these are reports of side effects that patients and doctors assume are from a drug, but they are not proven or verified.

If you experience a side effect or adverse event, do yourself and the medical community a favor and report it, even if you are not certain it’s that drug that caused it. The government is looking for patterns and surges. They need your input. Report your side effect here.

The FDA received 1.6 million adverse drug event reports in FAERS in 2016. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) monitor the safety of products after they are approved by FDA. FAERS is one of the “early warning” systems in place. Clinical reviewers scan for new adverse events/side effects or a sudden increase. When they spot a cluster in FAERS, CDER can dig deeper for a reason.

Testing the FAERS Database

I tested the system using 2 drugs:

1. Synthroid

I chose Synthroid because it’s the most prescribed drug in America, with more than 21,500,000 prescriptions each year, and because 3 women in my family take it. MedShadow reports it as being nearly side effect-free when the dosage of Synthroid is correct. When it’s off, it’s a problem — too much leads to fatigue, weight gain and depression. Too little brings insomnia, weak bones, breathlessness and possible heart problems.

Synthroid is used to supplement or replace the hormone that should be naturally produced by the thyroid. There were only about 12,900 reports to FAERS last year. It looks like most of the reports indicate that the dosage needed adjusting. The most common complaint was fatigue, at 10% of the total. Next were alopecia (hair loss) and drug ineffective (7.5%). Weight increase, blood thyroid-stimulating hormone increased, headache, feeling abnormal, palpitations, malaise, nausea, dizziness and insomnia were right behind, ranging from 4-6%.

If I were taking Synthroid, I’d work with my doctor on the dosage amount until the side effects disappeared. There should be no need to put up with side effects with Synthroid.

2. Crestor

Crestor is a statin prescribed to lower “bad” cholesterol and increase “good.” Cholesterol is an indicator of heart health. Crestor was the 2nd most-prescribed drug in 2016. With more than 21,400,000 prescriptions, it received only 37,900 total complaints in the FAERS system and only 2,095 in 2017.

That low number strikes me as very odd, because the number of people who stop taking statins because of the side effects varies from 3 in 10 to nearly half. So why so few reports? I don’t know.

The side effects that cause such a dropout rate include muscle discomfort, cognitive declines, increased risk of diabetes and rare cases of severe muscle damage.

The complaints in FAERS vary, but it’s interesting how many relate to pain. If they were totaled, it would come out to about 25% of all complaints:
10.3% – Myalgia (muscle pain)
5.8% – Pain in extremity
5.0% – Muscle spasms
4.31% – Pain

Two serious side effects showed up. Rhabdomyolysis, the very serious (and said to be rare) severe muscle damage causing muscle death and leading to kidney complications, was reported by 3.4% of Crestor users in FAERS; 1.9% reported type 2 diabetes. Because FAERS is voluntarily reported, frequency of adverse events/side effects can’t be calculated from these numbers.

If I were taking Crestor, I’d be highly alert to muscle pain (the first sign of rhabdomyolysis) and I’d discuss the risks with my doctor. (But don’t stop taking any prescribed medicine without discussing it with your healthcare provider.)

A Financial Side Effect of the New Database

The newly accessible FAERS website is having an effect already. CNBC reports that some biotech stocks’ share price dropped after information about what users were reporting on FAERS became available.

Other Side Effect Resources

FAERS is only for reporting on drug reactions. If you want to report or check on supplements, cosmetics, medical devices or vaccines, here are other FDA websites to use.
From the FDA FAERS website:

In addition to the FAERS database for drugs and biologics, the agency has adverse event reporting programs and databases for foods, dietary supplements, and cosmetics (CFSAN Adverse Event Reporting System, or “CAERS”), medical devices (Manufacturer and User Facility Device Experience, or “MAUDE”) and vaccines (Vaccine Adverse Event Reporting System, or “VAERS” that the FDA co-manages with the Centers for Disease Control and Prevention).

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of drug and biologic products to the FDA’s MedWatch Adverse Event Reporting program. To do so, complete and submit the report online at www.fda.gov/medwatch/report.htm; or download and complete the form, then submit it via fax at 1-800-FDA-0178.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.

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