August 2016 adverse event reports that FDA received in the month
What a report is
A report is not proof that the drug was the cause of the event.
FDA says:
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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports received
In August 2016, FDA received 95,445 drug adverse event reports. In August 2015, FDA received 116,062.
In August 2016, FDA received 83,538 medical device reports. In August 2015, FDA received 74,627.
By drug reports received, August 2016 was number 7 of the 12 months of 2016. FDA received 105,983 drug reports a month on average in the 12 months before August 2016.
Receive date
A month is the month in which FDA first received the report, not the month of the event. A report about an event of an earlier year is in the month in which it came to FDA.
Data version
FAERS release of 29 Oct 2026. MAUDE release of 23 Oct 2026.
Drug reports, three years
Drugs in the reports
The table has the 83 drug pages with 250 or more reports in August 2016. The rows are in order of name. A drug page with fewer reports is not in the table.
FDA says:
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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
Reaction terms in the reports
The table has the 101 reaction terms with 500 or more reports in August 2016. The rows are in order of name. One report can record more than one term.
FDA says:
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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
| Reaction term (MedDRA) and plain meaning | Reports in the month |
|---|---|
| Abdominal discomfortstomach discomfort | 944 |
| Abdominal distensiona bloated abdomen | 546 |
| Abdominal painstomach or belly pain | 1,069 |
| Abdominal pain upperupper stomach pain | 1,119 |
| Acute kidney injurysudden loss of kidney function | 866 |
| Alopeciahair loss | 834 |
| Anaemialow red blood cells | 909 |
| Anxietyanxiety | 1,112 |
| Arthralgiajoint pain | 1,722 |
| Astheniaweakness or lack of energy | 1,796 |
| Back painback pain | 1,117 |
| Blood glucose increasedraised blood sugar reading | 826 |
| Blood pressure increaseda raised blood pressure reading | 753 |
| Bronchitischest infection | 573 |
| Cerebrovascular accidentstroke | 706 |
| Chest painchest pain | 916 |
| Chillschills or shivering | 537 |
| Condition aggravatedthe condition being treated got worse | 1,383 |
| Confusional stateconfusion | 750 |
| Constipationconstipation | 1,177 |
| Contusiona bruise | 546 |
| Coughcough | 1,169 |
| Deaththe patient died; cause not stated by this term | 3,502 |
| Decreased appetitereduced appetite | 1,226 |
| Dehydrationdehydration | 719 |
| Depressionlow mood | 1,072 |
| Device use errora mistake in using the device | 702 |
| Diarrhoealoose or frequent stools | 3,299 |
| Dizzinesslight-headedness or unsteadiness | 2,496 |
| Drug dose omissiona dose was missed | 2,231 |
| Drug effect decreasedthe medicine had less effect | 537 |
| Drug hypersensitivityan allergic-type reaction (the term names a medicine) | 1,639 |
| Drug ineffectivethe medicine did not work as expected | 6,515 |
| Drug interactionan interaction between medicines | 740 |
| Drug intolerancethe medicine was not tolerated | 505 |
| Dyspnoeashortness of breath | 2,825 |
| Erythemaskin redness | 695 |
| Falla fall | 1,769 |
| Fatiguetiredness | 3,753 |
| Feeling abnormalfeeling odd or not right | 1,351 |
| Gait disturbancedifficulty walking | 942 |
| Gastrointestinal haemorrhagebleeding in the stomach or bowel | 862 |
| Haemorrhagebleeding | 514 |
| Headachehead pain | 3,634 |
| Hospitalisationadmission to hospital | 876 |
| Hyperhidrosisexcessive sweating | 646 |
| Hypersensitivityan allergic-type reaction | 777 |
| Hypertensionhigh blood pressure | 994 |
| Hypoaesthesianumbness | 676 |
| Hypotensionlow blood pressure | 983 |
| Inappropriate schedule of drug administrationthe medicine was taken at the wrong times | 780 |
| Incorrect dose administeredthe wrong dose was given | 748 |
| Infectionan infection, type not specified | 706 |
| Injection site erythemaredness where the injection was given | 583 |
| Injection site painpain where the injection was given | 958 |
| Insomniadifficulty sleeping | 1,327 |
| Intentional product misusedeliberate use not as intended | 829 |
| Joint swellinga swollen joint | 547 |
| Loss of consciousnesspassing out | 622 |
| Malaisegeneral feeling of being unwell | 2,710 |
| Memory impairmentmemory problems | 695 |
| Migrainemigraine | 511 |
| Muscle spasmsmuscle cramps | 961 |
| Muscular weaknessmuscle weakness | 546 |
| Myalgiamuscle pain | 833 |
| Myocardial infarctionheart attack | 631 |
| Nasopharyngitisa cold | 834 |
| Nauseafeeling sick | 4,155 |
| Neutropenialow neutrophils, a type of white blood cell | 684 |
| No adverse eventno adverse event was reported | 701 |
| Off label useused for a purpose or in a way not on the label | 3,450 |
| Overdosea dose above the recommended amount | 676 |
| Painpain, site not specified | 2,507 |
| Pain in extremitypain in an arm or leg | 1,435 |
| Palpitationsawareness of the heartbeat | 595 |
| Paraesthesiatingling or pins and needles | 725 |
| Peripheral swellingswelling of the arms or legs | 1,058 |
| Pneumonialung infection | 1,519 |
| Product quality issuea problem with the product itself | 1,166 |
| Product use issuea problem in how the product was used | 2,711 |
| Pruritusitching | 1,331 |
| Psoriasispsoriasis, a skin condition | 573 |
| Pyrexiafever | 1,608 |
| Rashskin rash | 1,692 |
| Renal failurekidney failure | 523 |
| Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease | 501 |
| Seizurea fit or convulsion | 750 |
| Sepsisa severe body-wide response to infection | 564 |
| Sinusitissinus infection | 1,068 |
| Somnolencedrowsiness | 1,146 |
| Swellingswelling | 539 |
| Toxicity to various agentspoisoning or toxic effect of one or more substances | 562 |
| Tremorshaking | 763 |
| Unevaluable eventthe event could not be assessed | 659 |
| Urinary tract infectionbladder or urinary infection | 863 |
| Urticariahives | 748 |
| Vision blurredblurred vision | 600 |
| Vomitingbeing sick | 2,366 |
| Weight decreasedweight loss | 1,442 |
| Weight increasedweight gain | 1,032 |
| Wrong technique in product usage processthe product was used in the wrong way | 1,208 |
Devices in the reports
The table has the 77 device pages with 100 or more reports in August 2016. The rows are in order of name. A device page with fewer reports is not in the table.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Cite this page
Reported Reactions. August 2016: adverse event reports received by FDA. https://reportedreactions.com/month/2016-08/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.
The device counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Can the count for August 2016 change?
Yes. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases. This page has the count of the openFDA release of 29 Oct 2026: 95,445 drug reports.
Does a month with many reports mean that something occurred in that month?
Not by itself. The date is the date on which FDA received the report, not the date of the event. FDA says:
Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
How does a person report an adverse event?
FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.