Drug level below therapeutic 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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 5,402 adverse event reports that record the MedDRA preferred term Drug level below therapeutic. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 346 reports in the 12 months to June 2026 and 275 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 1,173 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, 346 (under 0.1%) record this term. Reports for female patients were 32.6% 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.

Data version

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

Drugs in these reports

The table has the 110 drug pages with 10 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Drug level below therapeutic name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify Maintena		18
Abrilada		27
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	10
Adalimumab	Tumor necrosis factor blocker	54
Afinitor	Kinase inhibitor	26
Alprazolam	Benzodiazepine	14
Amphotericin b	Lipid-based polyene antifungal	18
Aripiprazole	Atypical antipsychotic	26
Azathioprine	Purine antimetabolite	43
Benztropine mesylate	Anticholinergic	17
Brivaracetam		14
Carbamazepine	Mood stabilizer	84
Ciprofloxacin	Fluoroquinolone antibacterial	15
Clobazam	Benzodiazepine	20
Clonazepam	Benzodiazepine	26
Clozapine	Atypical antipsychotic	38
Clozaril	Atypical antipsychotic	10
Cyclosporine	Calcineurin inhibitor immunosuppressant	27
Depakene		33
Depakote	Anti-epileptic agent	51
Dexamethasone	Corticosteroid	12
Diazepam	Benzodiazepine	67
Digoxin	Cardiac glycoside	30
Dilantin	Anti-epileptic agent	63
Divalproex sodium	Anti-epileptic agent	10
Dolutegravir		21
Efavirenz	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	14
Entyvio	Integrin receptor antagonist	16
Everolimus	Kinase inhibitor	12
Fentanyl	Opioid agonist	21
Flucloxacillin		23
Fluconazole	Azole antifungal	14
Fluvoxamine		34
Gabapentin	Anti-epileptic agent	13
Heparin		12
Human immunoglobulin g	Human immunoglobulin G	11
Humira		138
Inflectra	Tumor necrosis factor blocker	1,170
Infliximab	Tumor necrosis factor blocker	1,032
Infliximab Recombinant		59
Infliximab-dyyb	Tumor necrosis factor blocker	16
Isavuconazole		21
Itraconazole	Azole antifungal	30
Ixifi		18
Lacosamide		21
Lamictal	Anti-epileptic agent	11
Lamotrigine	Anti-epileptic agent	47
Levetiracetam		54
Linezolid	Oxazolidinone antibacterial	35
Lithium	Mood stabilizer	12
Lithium carbonate	Mood stabilizer	14
Lorazepam	Benzodiazepine	31
Loxapine succinate		14
Meperidine		12
Meropenem	Penem antibacterial	23
Metformin hydrochloride	Biguanide	15
Methotrexate	Folate analog metabolic inhibitor	33
Methotrexate sodium	Folate analog metabolic inhibitor	15
Methylene blue		19
Methylprednisolone	Corticosteroid	47
Midazolam	Benzodiazepine	23
Midazolam hydrochloride	Benzodiazepine	20
Mycophenolate mofetil	Antimetabolite immunosuppressant	31
Nordazepam		16
Norepinephrine	Catecholamine	15
Noxafil	Azole antifungal	66
Olanzapine	Atypical antipsychotic	54
Omeprazole	Proton pump inhibitor	22
Oxcarbazepine	Anti-epileptic agent	29
Paliperidone	Atypical antipsychotic	22
Pantoprazole	Proton pump inhibitor	16
Paroxetine hydrochloride	Serotonin reuptake inhibitor	13
Phenobarbital		14
Phenytoin	Anti-epileptic agent	106
Phenytoin sodium	Anti-epileptic agent	15
Posaconazole	Azole antifungal	37
Prednisolone	Corticosteroid	23
Prednisone	Corticosteroid	58
Prograf	Calcineurin inhibitor immunosuppressant	52
Propofol	General anesthetic	36
Propranolol	beta-Adrenergic blocker	13
Quetiapine	Atypical antipsychotic	37
Quetiapine fumarate	Atypical antipsychotic	57
Rapamune		26
Remicade	Tumor necrosis factor blocker	489
Rifampicin		19
Rifampin	Rifamycin antibacterial	34
Risperidone	Atypical antipsychotic	14
Ritonavir	Cytochrome P450 3A inhibitor	11
Rivaroxaban	Factor Xa inhibitor	10
Rocuronium	Nondepolarizing neuromuscular blocker	16
Saquinavir		10
Sevoflurane	General anesthetic	19
Simlandi		16
Sirolimus	Kinase inhibitor	15
Soliris	Complement inhibitor	10
Stelara	Interleukin-12 antagonist	143
Tacrolimus	Calcineurin inhibitor immunosuppressant	139
Tirosint	l-Thyroxine	69
Topiramate		17
Uzedy	Atypical antipsychotic	14
Valproate sodium	Anti-epileptic agent	22
Valproic acid	Anti-epileptic agent	107
Vancomycin	Glycopeptide antibacterial	21
Vedolizumab	Integrin receptor antagonist	76
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	10
Vfend	Azole antifungal	32
Voriconazole	Azole antifungal	162
Warfarin sodium	Vitamin K antagonist	15
Xarelto	Factor Xa inhibitor	12

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 60 pharmacologic classes with 5 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Drug level below therapeutic name, in order of name
Class	Reports with this term
Aldosterone antagonist	6
Alkylating drug	8
Allylamine antifungal	5
Aminosalicylate	16
Angiotensin converting enzyme inhibitor	5
Anti-coagulant	9
Anti-epileptic agent	503
Anticholinergic	23
Antimetabolite immunosuppressant	31
Antimycobacterial	8
Asparagine-specific enzyme	9
Atypical antipsychotic	288
Azole antifungal	348
Benzodiazepine	203
beta-Adrenergic blocker	31
Biguanide	15
Calcineurin inhibitor immunosuppressant	222
Cardiac glycoside	30
Catecholamine	17
CD20-directed cytolytic antibody	5
Complement inhibitor	10
Corticosteroid	164
Cytochrome P450 3A inhibitor	11
Dihydropyridine calcium channel blocker	13
Estrogen	8
Factor Xa inhibitor	26
Fluoroquinolone antibacterial	17
Folate analog metabolic inhibitor	48
gamma-Aminobutyric acid A receptor positive modulator	8
General anesthetic	59
Glycopeptide antibacterial	30
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	10
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	10
Histamine-1 receptor antagonist	7
HMG-CoA reductase inhibitor	12
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	16
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	6
Human immunoglobulin G	14
Integrin receptor antagonist	92
Interleukin-12 antagonist	145
Kinase inhibitor	67
l-Thyroxine	82
Lipid-based polyene antifungal	21
Loop diuretic	9
Mood stabilizer	117
Nondepolarizing neuromuscular blocker	18
Nonsteroidal anti-inflammatory drug	14
Opioid agonist	31
Opioid antagonist	9
Osmotic laxative	5
Oxazolidinone antibacterial	35
Penem antibacterial	27
Proton pump inhibitor	46
Purine antimetabolite	50
Rifamycin antibacterial	34
Serotonin and norepinephrine reuptake inhibitor	19
Serotonin reuptake inhibitor	41
Tumor necrosis factor blocker	2,790
Typical antipsychotic	7
Vitamin K antagonist	15

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

Reports by month

Reports that record Drug level below therapeutic, by month, five years to June 2026

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 Drug level below therapeutic
Age	Reports	Share
Under 2	41	0.8%
2 to 11	146	2.7%
12 to 17	189	3.5%
18 to 44	1,203	22.3%
45 to 64	993	18.4%
65 to 74	372	6.9%
75 and over	194	3.6%
Age not given	2,264	41.9%

Sex of the patient in the reports that record Drug level below therapeutic
Sex	Reports	Share
Female	1,761	32.6%
Male	1,908	35.3%
Unknown or not given	1,733	32.1%

Age and sex are as the report gives them. 29.3% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Drug level below therapeutic: adverse event reports that record this term. https://reportedreactions.com/reaction/drug-level-below-therapeutic/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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 Drug level below therapeutic 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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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