Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Abortion spontaneous adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
miscarriage

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 on file

From January 2004 to June 2026, FDA received 39,602 adverse event reports that record the MedDRA preferred term Abortion spontaneous. In plain words, the term means: miscarriage. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,704 reports in the 12 months to June 2026 and 1,888 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 404 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 1,704 (0.1%) record this term. Reports for female patients were 93.6% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Plain meaning

Miscarriage. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 109 drug pages with 100 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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 .

Drugs that the reports with the term Abortion spontaneous name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic253
AccutaneRetinoid150
AdalimumabTumor necrosis factor blocker145
AmoxicillinPenicillin-class antibacterial290
AripiprazoleAtypical antipsychotic211
AspirinNonsteroidal anti-inflammatory drug177
Atazanavir sulfateProtease inhibitor173
AvonexInterferon beta472
AzathioprinePurine antimetabolite152
Azithromycin Anhydrous246
BupropionAminoketone107
Bupropion hydrochlorideAminoketone161
CarbamazepineMood stabilizer151
Certolizumab pegolTumor necrosis factor blocker370
CimziaTumor necrosis factor blocker282
CiprofloxacinFluoroquinolone antibacterial379
Ciprofloxacin hydrochlorideFluoroquinolone antibacterial115
ClaravisRetinoid183
ClarithromycinMacrolide antimicrobial301
ClobazamBenzodiazepine123
CombivirHepatitis B virus nucleoside analog reverse transcriptase inhibitor298
Copaxone177
CosentyxInterleukin-17A antagonist161
Cymbalta261
DarunavirProtease inhibitor151
Depo-ProveraProgestin154
Dolutegravir219
DupixentInterleukin-4 receptor alpha antagonist214
EfavirenzHuman immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor276
Emtricitabine and tenofovir disoproxil fumarateHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor361
Emtricitabine Tenofovir Disoproxil Fumarate121
EnbrelTumor necrosis factor blocker669
Enoxaparin sodiumLow molecular weight heparin111
EntyvioIntegrin receptor antagonist108
EpivirHepatitis B virus nucleoside analog reverse transcriptase inhibitor101
Erythromycin186
FluconazoleAzole antifungal175
Folic acid180
GabapentinAnti-epileptic agent112
GilenyaSphingosine 1-phosphate receptor modulator350
Gonal-f111
Humira1,859
HydroxychloroquineAntimalarial103
IbuprofenNonsteroidal anti-inflammatory drug219
Implanon337
InflectraTumor necrosis factor blocker127
InfliximabTumor necrosis factor blocker169
IsentressHuman immunodeficiency virus integrase strand transfer inhibitor194
IsotretinoinRetinoid215
KaletraCytochrome P450 3A inhibitor348
Keppra325
KesimptaCD20-directed cytolytic antibody169
Lacosamide186
LamictalAnti-epileptic agent282
LamivudineHepatitis B virus nucleoside analog reverse transcriptase inhibitor288
LamotrigineAnti-epileptic agent493
LantusInsulin analog100
Levetiracetam1,582
Levothyroxine132
LovenoxLow molecular weight heparin105
Makena480
MetforminBiguanide145
MethotrexateFolate analog metabolic inhibitor260
MetronidazoleNitroimidazole antimicrobial360
MirenaProgestin982
MounjaroGLP-1 receptor agonist108
Mycophenolate mofetilAntimetabolite immunosuppressant275
NevirapineHuman immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor155
NexplanonProgestin594
NorvirCytochrome P450 3A inhibitor335
NuvaringEstrogen266
OcrevusCD20-directed cytolytic antibody147
Ortho Evra116
ParaGard T 380ACopper-containing intrauterine device482
PlegridyInterferon beta130
PrednisoloneCorticosteroid227
PrednisoneCorticosteroid292
PrezistaProtease inhibitor180
ProgesteroneProgesterone190
PrografCalcineurin inhibitor immunosuppressant115
QuetiapineAtypical antipsychotic217
RebifInterferon beta557
RemicadeTumor necrosis factor blocker585
ReyatazProtease inhibitor199
RitonavirCytochrome P450 3A inhibitor364
RituximabCD20-directed cytolytic antibody138
SkyriziInterleukin-23 antagonist252
SolirisComplement inhibitor102
StelaraInterleukin-12 antagonist192
SuboxoneOpioid antagonist270
Subutex174
TacrolimusCalcineurin inhibitor immunosuppressant200
Tecfidera557
TegretolMood stabilizer350
Tenofovir disoproxil fumarateHepatitis B virus nucleoside analog reverse transcriptase inhibitor262
TivicayHuman immunodeficiency virus integrase strand transfer inhibitor162
Topamax133
Topiramate244
TrileptalAnti-epileptic agent106
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor494
TysabriIntegrin receptor antagonist1,278
Valproate sodiumAnti-epileptic agent116
Valproic acidAnti-epileptic agent181
VedolizumabIntegrin receptor antagonist260
Viramune155
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor169
XolairAnti-IgE272
XyremCentral nervous system depressant165
Yasmin101

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 40 pharmacologic classes with 250 or more reports that record this term. The rows are in order of name.

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 .

Pharmacologic classes of the drugs that the reports with the term Abortion spontaneous name, in order of name
ClassReports with this term
Aminoketone346
Anti-epileptic agent1,538
Anti-IgE315
Antimetabolite immunosuppressant404
Atypical antipsychotic1,120
Benzodiazepine451
Calcineurin inhibitor immunosuppressant398
CD20-directed cytolytic antibody538
Copper-containing intrauterine device482
Corticosteroid706
Cytochrome P450 3A inhibitor1,109
Estrogen322
Fluoroquinolone antibacterial564
Folate analog metabolic inhibitor325
GLP-1 receptor agonist372
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor1,248
Histamine-1 receptor antagonist267
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor541
Human immunodeficiency virus integrase strand transfer inhibitor423
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor1,204
Insulin analog420
Integrin receptor antagonist1,650
Interferon beta1,212
Interleukin-23 antagonist296
Interleukin-4 receptor alpha antagonist258
Macrolide antimicrobial362
Mood stabilizer509
Nitroimidazole antimicrobial364
Nonsteroidal anti-inflammatory drug555
Opioid agonist562
Opioid antagonist274
Penicillin-class antibacterial309
Progestin2,145
Protease inhibitor785
Purine antimetabolite250
Retinoid748
Serotonin and norepinephrine reuptake inhibitor341
Serotonin reuptake inhibitor697
Sphingosine 1-phosphate receptor modulator385
Tumor necrosis factor blocker2,559

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Abortion spontaneous, by month, five years to June 2026
025050020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Abortion spontaneous
AgeReportsShareShare as a bar
Under 2890.2%
2 to 112under 0.1%
12 to 172650.7%
18 to 4419,62549.6%
45 to 644121%
65 to 749under 0.1%
75 and over1under 0.1%
Age not given19,19948.5%
Sex of the patient in the reports that record Abortion spontaneous
SexReportsShareShare as a bar
Female37,08393.6%
Male1480.4%
Unknown or not given2,3716%

Age and sex are as the report gives them. 38.5% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

Reported Reactions. Abortion spontaneous: adverse event reports that record this term. https://reportedreactions.com/reaction/abortion-spontaneous/ 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 count has the reports with each spelling of one MedDRA preferred term. 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

What does Abortion spontaneous mean in an adverse event report?

In plain words: miscarriage. It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .