The Many Rx Reactions Reported by Americans

Death and nausea top medication side effects reported to FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Newly released data tracking reports on the negative side effects of prescription medications is a stark reminder of the potentially deadly complications of medicine.

Between 2004 and 2013, the US Food and Drug Administration tracked the most common side effects of prescription medications in men and women.

In that timeframe, more than 120,000 men and women died from what’s called an “adverse drug event.”

The data also showed that women reported many more medication reactions than men.

"Ask your pharmacist about the possible side effects of prescription medications."

The FDA made the data report, and many others, available June 2 through its new openFDA public access project, which is still in an early beta version.

The department, charged with regulating over-the-counter and prescription medications, received reports of harmful side effects primarily from drug manufacturers, but also from consumers, doctors, pharmacists and lawyers.

From 2004 to 2013, the FDA fielded some 3,643,503 reports about bad responses to prescription medications.

The most commonly reported problem was that the medications was ineffective — that problem was reported 167,482 times, according to the data.

Nausea came in second with 162,962 reported cases, followed in third place by death. Death resulting from medication use was reported 143,504 times.

For men between ages 55 and 90, death was the leading adverse drug event with 17,421 instances reported to the FDA. In women of the same age group, nausea was the leading side effect reported with 32,826 reports.

In total, women reported nearly twice the amount of incidents as men, according to reporting from The Washington Post.

For the data period covered, there were more than 2 million reports from women compared to less than 1.3 million reports from men. Further, women were more likely than men to report more than one negative effect of a prescription, according to The Washington Post.

About half of the reports from women, according to the Post, actually came from the consumer, whereas more than 60 percent of reports from men came from another source, such as the manufacturer.

Dr. Michael Carome, director of the health research group at Public Citizen, told The Washington Post that voluntary reporting of adverse events, as is the case with the new FDA data, could lead to underreporting.

“There’s likely many more adverse events occurring than you get from this database," said Dr. Carome.

Sean Herron, a Presidential Innovation Fellow working at the FDA, said in a prepared statement that the data set, newly accessible to the general public, could be a “valuable tool in creating application that help preserve and protect the public health.” He acknowledged that “the data is sometimes a bit messy.”

Review Date: 
June 9, 2014
Last Updated:
June 11, 2014