Drug Side Effects Reported to FDA Skyrocket

Since 2004, the number of side effects reported to the FDA has increased nearly fivefold, according to a new analysis.

In 2004, 205,727 drug-related side effects were reported to the FDA. In 2015, the number skyrocketed to 1.19 million, an increase of 477.2%, according to data compiled by the Milwaukee Journal Sentinel and MedPage Today.

Figures for 2016 are not yet available, but they are expected to at least match the number of reports seen in 2015.

Drugs used to treat conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, a type of cancer and diabetes garnered the greatest number of reports.

The actual number of side effects is likely much higher, as reporting of side effects is voluntary.

One reason for the surge is that in 2015, the FDA began requiring drugmakers to report side effects electronically, rather than on paper. That led to an increase in reports of not so serious events, and 300,000 additional reports, the largest year-over-year jump since the agency began compiling side effect reports.

Also, reporting of side effects is increasingly coming from patients rather than doctors. In 2004, 20% of reports came from patients. By 2013, patient reports of side effects outnumbered those reported by medical professionals. In 2015, patients accounted for 55% of side effect reports.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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