December 2019 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 December 2019, FDA received 124,534 drug adverse event reports. In December 2018, FDA received 101,047.
In December 2019, FDA received 144,493 medical device reports. In December 2018, FDA received 84,989.
By drug reports received, December 2019 was number 2 of the 12 months of 2019. FDA received 117,559 drug reports a month on average in the 12 months before December 2019.
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 52 drug pages with 500 or more reports in December 2019. 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 .
| Drug | Reports in the month |
|---|---|
| Actemra | 696 |
| Aimovig | 591 |
| Carboplatin | 614 |
| Cimzia | 4,492 |
| Cosentyx | 2,565 |
| Cyclophosphamide | 950 |
| Dexamethasone | 906 |
| Docetaxel | 1,006 |
| Dupixent | 1,449 |
| Eliquis | 1,324 |
| Enbrel | 2,040 |
| Entresto | 1,334 |
| Epidiolex | 636 |
| Gilenya | 1,524 |
| Humira | 2,888 |
| Ibrance | 859 |
| Ibuprofen | 538 |
| Imbruvica | 1,168 |
| Keppra | 605 |
| Lergigan | 1,069 |
| Levetiracetam | 978 |
| Lyrica | 547 |
| Metformin | 729 |
| Methotrexate | 2,056 |
| Methotrexate sodium | 681 |
| Mycophenolate mofetil | 1,513 |
| Nivolumab | 541 |
| Ocrevus | 1,126 |
| Olanzapine | 549 |
| Omeprazole | 525 |
| Orencia | 1,041 |
| Otezla | 1,943 |
| Paracetamol | 528 |
| ParaGard T 380A | 3,318 |
| Pomalyst | 670 |
| Prednisolone | 812 |
| Prednisone | 1,427 |
| Prolia | 510 |
| Propavan | 865 |
| Quetiapine | 604 |
| Remicade | 972 |
| Repatha | 737 |
| Revlimid | 2,328 |
| Rituximab | 905 |
| Sertraline | 631 |
| Simponi | 564 |
| Stelara | 702 |
| Tacrolimus | 1,091 |
| Taxotere | 1,075 |
| Tecfidera | 726 |
| Vimpat | 697 |
| Xeljanz | 1,604 |
Reaction terms in the reports
The table has the 141 reaction terms with 500 or more reports in December 2019. 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 | 1,051 |
| Abdominal distensiona bloated abdomen | 592 |
| Abdominal painstomach or belly pain | 1,348 |
| Abdominal pain upperupper stomach pain | 1,166 |
| Accidental exposure to product | 542 |
| Acute kidney injurysudden loss of kidney function | 1,310 |
| Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine) | 555 |
| Adverse eventan unwanted medical event, type not specified | 551 |
| Alopeciahair loss | 2,420 |
| Anaemialow red blood cells | 1,082 |
| Anxietyanxiety | 1,950 |
| Arthralgiajoint pain | 2,184 |
| Astheniaweakness or lack of energy | 1,929 |
| Asthmaasthma | 685 |
| Atrial fibrillationan irregular heart rhythm | 547 |
| Back painback pain | 1,230 |
| Blood glucose increasedraised blood sugar reading | 832 |
| Blood pressure increaseda raised blood pressure reading | 881 |
| Bronchitischest infection | 507 |
| Cardiac failureheart failure | 542 |
| Cerebrovascular accidentstroke | 700 |
| Chest discomfortchest discomfort | 618 |
| Chest painchest pain | 904 |
| Chillschills or shivering | 596 |
| Chronic kidney diseaselong-term kidney disease | 638 |
| Coma | 504 |
| Complication of device insertion | 946 |
| Condition aggravatedthe condition being treated got worse | 1,838 |
| Confusional stateconfusion | 890 |
| Constipationconstipation | 1,096 |
| Contusiona bruise | 599 |
| Coughcough | 2,055 |
| Crohn's disease | 524 |
| Deaththe patient died; cause not stated by this term | 5,588 |
| Decreased appetitereduced appetite | 1,407 |
| Dehydrationdehydration | 672 |
| Depressed level of consciousness | 667 |
| Depressionlow mood | 1,148 |
| Device expulsionthe device came out | 1,755 |
| Device issuea problem with the device | 698 |
| Diarrhoealoose or frequent stools | 3,941 |
| Discomfortdiscomfort | 607 |
| Disease progressionthe disease advanced | 556 |
| Dizzinesslight-headedness or unsteadiness | 2,735 |
| Drug hypersensitivityan allergic-type reaction (the term names a medicine) | 1,427 |
| Drug ineffectivethe medicine did not work as expected | 8,861 |
| Drug interactionan interaction between medicines | 1,123 |
| Drug intolerancethe medicine was not tolerated | 920 |
| Dyspnoeashortness of breath | 3,367 |
| Emotional distressemotional distress | 869 |
| Erythemaskin redness | 961 |
| Falla fall | 1,994 |
| Fatiguetiredness | 4,921 |
| Feeling abnormalfeeling odd or not right | 1,411 |
| Foetal exposure during pregnancythe unborn baby was exposed to the medicine | 516 |
| Gait disturbancedifficulty walking | 1,082 |
| Gastrointestinal disorder | 516 |
| General physical health deteriorationgeneral decline in health | 661 |
| Haemoglobin decreasedlow haemoglobin | 557 |
| Haemorrhagebleeding | 618 |
| Hallucinationseeing or hearing things that are not there | 523 |
| Headachehead pain | 3,735 |
| Heart rate increaseda fast heart rate reading | 566 |
| Hospitalisationadmission to hospital | 987 |
| Hyperhidrosisexcessive sweating | 629 |
| Hypersensitivityan allergic-type reaction | 1,066 |
| Hypertensionhigh blood pressure | 1,222 |
| Hypoaesthesianumbness | 795 |
| Hypotensionlow blood pressure | 1,323 |
| Inappropriate schedule of product administrationthe product was taken at the wrong times | 1,434 |
| Incorrect dose administeredthe wrong dose was given | 1,073 |
| Infectionan infection, type not specified | 970 |
| Influenzaflu | 872 |
| Injection site painpain where the injection was given | 1,255 |
| Insomniadifficulty sleeping | 1,287 |
| Intentional overdosea deliberate overdose | 2,330 |
| Intentional product misusedeliberate use not as intended | 665 |
| Intentional product use issuedeliberate use not as intended | 833 |
| Intentional self-injury | 1,970 |
| Joint swellinga swollen joint | 705 |
| Loss of consciousnesspassing out | 773 |
| Malaisegeneral feeling of being unwell | 3,202 |
| Malignant neoplasm progression | 881 |
| Maternal exposure during pregnancythe mother took the medicine during pregnancy | 822 |
| Memory impairmentmemory problems | 871 |
| Migrainemigraine | 610 |
| Muscle spasmsmuscle cramps | 1,122 |
| Muscular weaknessmuscle weakness | 555 |
| Musculoskeletal stiffnessstiffness in muscles or joints | 527 |
| Myalgiamuscle pain | 871 |
| Myocardial infarctionheart attack | 549 |
| Nasopharyngitisa cold | 1,562 |
| Nauseafeeling sick | 4,326 |
| Neutropenialow neutrophils, a type of white blood cell | 830 |
| No adverse eventno adverse event was reported | 1,171 |
| Off label useused for a purpose or in a way not on the label | 5,462 |
| Oropharyngeal painsore throat | 548 |
| Overdosea dose above the recommended amount | 766 |
| Painpain, site not specified | 3,820 |
| Pain in extremitypain in an arm or leg | 1,542 |
| Palpitationsawareness of the heartbeat | 643 |
| Paraesthesiatingling or pins and needles | 848 |
| Peripheral swellingswelling of the arms or legs | 1,074 |
| Platelet count decreasedlow platelet count | 648 |
| Pneumonialung infection | 2,274 |
| Product dose omissiona dose was missed | 3,176 |
| Product dose omission issuea dose was missed | 503 |
| Product quality issuea problem with the product itself | 602 |
| Product storage errorthe product was stored wrongly | 546 |
| Product use in unapproved indicationused for a purpose not on the label | 2,373 |
| Product use issuea problem in how the product was used | 1,001 |
| Pruritusitching | 2,082 |
| Psoriasispsoriasis, a skin condition | 997 |
| Pyrexiafever | 2,103 |
| Rashskin rash | 2,813 |
| Renal failurekidney failure | 843 |
| Renal impairmentreduced kidney function | 557 |
| Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease | 1,029 |
| Seizurea fit or convulsion | 1,179 |
| Sepsisa severe body-wide response to infection | 715 |
| Sinusitissinus infection | 772 |
| Somnolencedrowsiness | 1,314 |
| Swellingswelling | 660 |
| Syncopefainting | 628 |
| Tachycardiafast heart rate | 837 |
| Therapeutic product effect decreased | 590 |
| Therapeutic product effect incomplete | 932 |
| Therapy cessation | 860 |
| Thrombocytopenialow platelets | 738 |
| Toxicity to various agentspoisoning or toxic effect of one or more substances | 1,202 |
| Treatment failurethe treatment did not work | 541 |
| Tremorshaking | 907 |
| Urinary tract infectionbladder or urinary infection | 1,014 |
| Urticariahives | 967 |
| Vision blurredblurred vision | 730 |
| Visual impairmentreduced vision | 819 |
| Vomitingbeing sick | 2,610 |
| Weight decreasedweight loss | 1,572 |
| Weight increasedweight gain | 1,144 |
| White blood cell count decreasedlow white cell count | 770 |
| Wrong technique in product usage processthe product was used in the wrong way | 1,327 |
Devices in the reports
The table has the 59 device pages with 250 or more reports in December 2019. 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. December 2019: adverse event reports received by FDA. https://reportedreactions.com/month/2019-12/ 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 December 2019 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: 124,534 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.