Reported Reactions

Adverse event reports that FDA received

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Foetal growth restriction adverse event reports that record this term

Kind of term
MedDRA preferred term

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 5,958 adverse event reports that record the MedDRA preferred term Foetal growth restriction. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 423 reports in the 12 months to June 2026 and 380 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 1,065 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, 423 (under 0.1%) record this term. Reports for patients aged 45 to 64 were 0.2% of the reports that record this term and 20% 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.

Data version

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

Drugs in these reports

The table has the 141 drug pages with 25 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 Foetal growth restriction name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic83
Acetaminophen59
Acetylsalicylic Acid138
AlprazolamBenzodiazepine49
Amitriptyline hydrochlorideTricyclic antidepressant54
AmlodipineCalcium channel blocker84
AmoxicillinPenicillin-class antibacterial25
AripiprazoleAtypical antipsychotic29
AspirinNonsteroidal anti-inflammatory drug267
Atarax35
Atenololbeta-Adrenergic blocker30
AzathioprinePurine antimetabolite204
Betamethasone121
Bisoprololbeta-Adrenergic blocker171
Bisoprolol fumaratebeta-Adrenergic blocker42
BleomycinCytoprotective agent27
BuprenorphinePartial opioid agonist46
Calcium28
CarboplatinPlatinum-based drug77
CeftazidimeCephalosporin antibacterial31
CeftriaxoneCephalosporin antibacterial62
CefuroximeCephalosporin antibacterial34
Certolizumab pegolTumor necrosis factor blocker42
Ciclosporin35
CimziaTumor necrosis factor blocker31
CisplatinPlatinum-based drug43
CitalopramSerotonin reuptake inhibitor39
Clexane37
CombivirHepatitis B virus nucleoside analog reverse transcriptase inhibitor41
CyclophosphamideAlkylating drug205
CyclosporineCalcineurin inhibitor immunosuppressant76
CytarabineNucleoside metabolic inhibitor51
Darbepoetin alfaErythropoiesis-stimulating agent37
DarunavirProtease inhibitor41
Daunorubicin26
DexamethasoneCorticosteroid177
DiazepamBenzodiazepine29
DiclofenacNonsteroidal anti-inflammatory drug30
Dolutegravir39
DoxorubicinAnthracycline topoisomerase inhibitor130
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor54
EnbrelTumor necrosis factor blocker25
Enoxaparin70
Enoxaparin sodiumLow molecular weight heparin56
Epzicom32
EscitalopramSerotonin reuptake inhibitor40
EsomeprazoleProton pump inhibitor54
EtoposideTopoisomerase inhibitor94
FentanylOpioid agonist28
FluorouracilNucleoside metabolic inhibitor37
Folic acid102
FurosemideLoop diuretic107
GabapentinAnti-epileptic agent49
Heparin59
Human immunoglobulin gHuman immunoglobulin G60
Humira127
Hydralazine30
HydrocortisoneCorticosteroid46
HydroxychloroquineAntimalarial144
HydroxyureaAntimetabolite31
IbuprofenNonsteroidal anti-inflammatory drug60
IfosfamideAlkylating drug72
InsulinInsulin analog32
Iron34
IsentressHuman immunodeficiency virus integrase strand transfer inhibitor33
KaletraCytochrome P450 3A inhibitor48
Kardegic26
Keppra54
Kivexa38
Labetalolbeta-Adrenergic blocker85
LamictalAnti-epileptic agent40
LamivudineHepatitis B virus nucleoside analog reverse transcriptase inhibitor63
LamotrigineAnti-epileptic agent61
Levetiracetam130
Levothyroxine85
LovenoxLow molecular weight heparin73
Magnesium sulfateCalculi dissolution agent29
Makena70
MesalamineAminosalicylate26
MesnaCytoprotective agent44
MetforminBiguanide52
MethadoneOpioid agonist56
MethotrexateFolate analog metabolic inhibitor88
MethyldopaCentral alpha-2 adrenergic agonist161
MethylprednisoloneCorticosteroid150
MetoclopramideDopamine-2 receptor antagonist36
Metoprololbeta-Adrenergic blocker112
MidazolamBenzodiazepine25
Mirtazapine33
Mycophenolate mofetilAntimetabolite immunosuppressant47
NevirapineHuman immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor34
NifedipineDihydropyridine calcium channel blocker166
NorvirCytochrome P450 3A inhibitor111
Novorapid28
OmeprazoleProton pump inhibitor71
OndansetronSerotonin-3 receptor antagonist76
OxazepamBenzodiazepine82
PaclitaxelMicrotubule inhibitor91
PantoprazoleProton pump inhibitor64
Paracetamol30
PlaquenilAntimalarial32
Potassium chlorideOsmotic laxative32
PrednisoloneCorticosteroid290
PrednisoneCorticosteroid228
PrezcobixCytochrome P450 3A inhibitor28
PrezistaProtease inhibitor77
ProgesteroneProgesterone28
PropofolGeneral anesthetic27
Propranololbeta-Adrenergic blocker80
ProzacSerotonin reuptake inhibitor27
QuetiapineAtypical antipsychotic58
RanitidineHistamine-2 receptor antagonist34
RemicadeTumor necrosis factor blocker32
ReyatazProtease inhibitor64
RitonavirCytochrome P450 3A inhibitor43
RituximabCD20-directed cytolytic antibody127
SeroquelAtypical antipsychotic27
SertralineSerotonin reuptake inhibitor87
SildenafilPhosphodiesterase 5 inhibitor37
SolirisComplement inhibitor37
Subutex33
SumatriptanSerotonin-1b and Serotonin-1d receptor agonist47
TacrolimusCalcineurin inhibitor immunosuppressant190
Tenofovir disoproxil fumarateHepatitis B virus nucleoside analog reverse transcriptase inhibitor54
TivicayHuman immunodeficiency virus integrase strand transfer inhibitor43
Topiramate45
Trandate55
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor89
TysabriIntegrin receptor antagonist43
ValiumBenzodiazepine32
Valproate sodiumAnti-epileptic agent34
ValsartanAngiotensin 2 receptor blocker29
VancomycinGlycopeptide antibacterial36
VenlafaxineSerotonin and norepinephrine reuptake inhibitor57
Venlafaxine hydrochlorideSerotonin and norepinephrine reuptake inhibitor25
Vinblastine35
Vincristine67
ZidovudineHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor51
Zofran32
ZoloftSerotonin reuptake inhibitor30
Zopiclone33

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 49 pharmacologic classes with 50 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 Foetal growth restriction name, in order of name
ClassReports with this term
Alkylating drug305
Angiotensin 2 receptor blocker103
Angiotensin converting enzyme inhibitor51
Anthracycline topoisomerase inhibitor197
Anti-epileptic agent239
Antimalarial199
Antimetabolite immunosuppressant52
Atypical antipsychotic273
Benzodiazepine278
beta-Adrenergic blocker616
Biguanide73
Calcineurin inhibitor immunosuppressant294
Calcium channel blocker95
CD20-directed cytolytic antibody135
Central alpha-2 adrenergic agonist169
Cephalosporin antibacterial171
Corticosteroid975
Cytochrome P450 3A inhibitor235
Cytoprotective agent73
Dihydropyridine calcium channel blocker209
Erythropoiesis-stimulating agent81
Factor Xa inhibitor52
Folate analog metabolic inhibitor99
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor196
Histamine-2 receptor antagonist52
Human immunodeficiency virus integrase strand transfer inhibitor78
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor261
Human immunoglobulin G92
Insulin analog93
Integrin receptor antagonist60
Loop diuretic110
Low molecular weight heparin129
Microtubule inhibitor105
Nonsteroidal anti-inflammatory drug375
Nucleoside metabolic inhibitor111
Opioid agonist166
Osmotic laxative52
Partial opioid agonist50
Platinum-based drug137
Protease inhibitor198
Proton pump inhibitor245
Purine antimetabolite218
Serotonin and norepinephrine reuptake inhibitor109
Serotonin reuptake inhibitor298
Serotonin-1b and Serotonin-1d receptor agonist57
Serotonin-3 receptor antagonist82
Topoisomerase inhibitor101
Tricyclic antidepressant54
Tumor necrosis factor blocker185

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

Reports by month

Reports that record Foetal growth restriction, by month, five years to June 2026
05010020222023202420252026

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 Foetal growth restriction
AgeReportsShareShare as a bar
Under 294315.8%
2 to 11220.4%
12 to 1750.1%
18 to 4465511%
45 to 6490.2%
65 to 7400%
75 and over00%
Age not given4,32472.6%
Sex of the patient in the reports that record Foetal growth restriction
SexReportsShareShare as a bar
Female2,56543.1%
Male1,41223.7%
Unknown or not given1,98133.2%

Age and sex are as the report gives them. 20.5% 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

Reported Reactions. Foetal growth restriction: adverse event reports that record this term. https://reportedreactions.com/reaction/foetal-growth-restriction/ 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 Foetal growth restriction mean in an adverse event report?

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 .