Index · 1,436 MedDRA terms

Reactions recorded in FDA adverse event reports

MedDRA preferred terms with 5,000 or more reports. A term is what a coder chose to represent the reporter's description; it is not a finding about any product.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Recorded most often

Term	Reports	Share of all reports	Latest 12 months
Drug ineffectivethe medicine did not work as expected	1,296,884	6.3%	71,499
Off label useused for a purpose or in a way not on the label	856,363	4.2%	79,953
Deaththe patient died; cause not stated by this term	847,572	4.1%	48,702
Nauseafeeling sick	776,030	3.8%	48,716
Fatiguetiredness	765,038	3.7%	45,513
Diarrhoealoose or frequent stools	633,344	3.1%	43,937
Headachehead pain	616,001	3%	34,426
Painpain, site not specified	606,385	2.9%	27,198
Dyspnoeashortness of breath	556,535	2.7%	30,572
Dizzinesslight-headedness or unsteadiness	489,289	2.4%	27,714
Vomitingbeing sick	461,238	2.2%	30,200
Malaisegeneral feeling of being unwell	433,298	2.1%	19,272
Rashskin rash	426,662	2.1%	30,060
Arthralgiajoint pain	408,118	2%	26,775
Pruritusitching	372,191	1.8%	35,233
Astheniaweakness or lack of energy	369,852	1.8%	19,677
Pyrexiafever	340,424	1.7%	17,418
Falla fall	327,585	1.6%	17,721
Pneumonialung infection	318,354	1.5%	19,520
Injection site painpain where the injection was given	299,308	1.5%	26,190
Condition aggravatedthe condition being treated got worse	297,499	1.4%	25,062
Pain in extremitypain in an arm or leg	290,578	1.4%	12,507
Product dose omission issuea dose was missed	280,968	1.4%	48,930
Anxietyanxiety	280,452	1.4%	12,647
Coughcough	275,563	1.3%	17,062
Weight decreasedweight loss	274,677	1.3%	14,713
Insomniadifficulty sleeping	262,118	1.3%	12,076
Product use in unapproved indicationused for a purpose not on the label	241,069	1.2%	25,367
Feeling abnormalfeeling odd or not right	236,560	1.2%	9,076
Back painback pain	228,810	1.1%	11,296
Abdominal painstomach or belly pain	228,697	1.1%	14,037
Decreased appetitereduced appetite	228,270	1.1%	15,276
Depressionlow mood	224,407	1.1%	8,506
Incorrect dose administeredthe wrong dose was given	221,921	1.1%	24,091
Weight increasedweight gain	219,001	1.1%	14,300
Overdosea dose above the recommended amount	213,059	1%	7,825
Constipationconstipation	212,934	1%	16,994
Hypertensionhigh blood pressure	208,347	1%	11,682
Erythemaskin redness	202,210	1%	11,146
Abdominal pain upperupper stomach pain	202,116	1%	13,158