Teralithe adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Teralithe
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From March 2004 to June 2026, FDA received 1,806 adverse event reports that name Teralithe. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 639 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 167 reports in the 12 months to June 2026 and 203 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 167 (under 0.1%) name Teralithe. Reports from consumers or other non-health professionals were 8.4% of the reports that name Teralithe and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
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.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Teralithe is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

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

Since the last update

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 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 39 reports that name Teralithe.
In January to March 2026, FDA received 43.
In April to June 2025, FDA received 49.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 213 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,764 of the 1,806 reports (97.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 213 terms.

Reaction terms in the reports that name Teralithe, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,806 reports
Confusional stateconfusion	234	13%
Coma	210	11.6%
Acute kidney injurysudden loss of kidney function	195	10.8%
Drug interactionan interaction between medicines	182	10.1%
Somnolencedrowsiness	181	10%
Antipsychotic drug level increased	180	10%
Tremorshaking	155	8.6%
Toxicity to various agentspoisoning or toxic effect of one or more substances	149	8.3%
Poisoning deliberate	144	8%
Extrapyramidal disordermovement problems such as stiffness or tremor	127	7%
Encephalopathy	90	5%
Vomitingbeing sick	84	4.7%
Overdosea dose above the recommended amount	82	4.5%
Dysarthria	73	4%
Electrocardiogram QT prolongeda QT prolongation on the ECG	69	3.8%
Intentional overdosea deliberate overdose	66	3.7%
Diarrhoealoose or frequent stools	61	3.4%
Falla fall	61	3.4%
Antipsychotic drug level above therapeutic	54	3%
Disorientation	52	2.9%
Hypotensionlow blood pressure	51	2.8%
Renal failurekidney failure	51	2.8%
Cerebellar syndrome	41	2.3%
Tachycardiafast heart rate	40	2.2%
Altered state of consciousness	39	2.2%
Hypernatraemia	38	2.1%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	38	2.1%
Disturbance in attentiondifficulty concentrating	37	2%
Hypercalcaemiahigh blood calcium	37	2%
Pneumonia aspirationlung infection from breathing in material	36	2%
Gait disturbancedifficulty walking	35	1.9%
Cardio-respiratory arrestthe heart and breathing stopped	34	1.9%
Muscle rigidity	34	1.9%
Rhabdomyolysismuscle breakdown	34	1.9%
Miosis	32	1.8%
Speech disordera speech problem	32	1.8%
Toxic encephalopathy	32	1.8%
Balance disorderproblems with balance	30	1.7%
Depressed level of consciousness	28	1.6%
Urinary retentionbeing unable to empty the bladder	28	1.6%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	27	1.5%
Tubulointerstitial nephritis	27	1.5%
Psychomotor skills impaired	26	1.4%
Bradycardiaslow heart rate	24	1.3%
Dehydration	24	1.3%
Drug abusemisuse of a medicine	24	1.3%
Oxygen saturation decreased	24	1.3%
Suicide attempta suicide attempt	24	1.3%
Dyskinesiainvoluntary movements	23	1.3%
Agitationrestlessness	22	1.2%

Download all 213 terms of Teralithe (CSV)

The counts add to more than 1,806 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Teralithe, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	8	8	1	0	6	0	0	1	0
2005	12	12	2	1	9	1	0	0	0
2006	12	12	1	1	9	0	0	1	0
2007	6	6	0	1	5	0	0	0	0
2008	9	9	1	2	9	0	0	0	0
2009	16	16	2	2	9	0	0	6	0
2010	20	20	0	4	15	1	0	7	0
2011	10	10	3	0	6	0	1	5	0
2012	9	9	5	1	6	1	0	1	0
2013	32	32	2	8	21	0	1	10	0
2014	34	34	0	10	31	2	0	12	0
2015	31	31	2	4	24	3	0	11	0
2016	44	44	1	5	36	1	0	20	0
2017	75	75	6	10	48	1	9	32	0
2018	153	153	4	30	109	0	4	56	0
2019	211	211	23	51	130	2	2	57	0
2020	200	200	0	25	136	0	0	84	0
2021	146	146	5	30	94	0	0	55	0
2022	108	106	6	18	65	1	2	48	2
2023	174	174	12	43	113	1	1	73	0
2024	206	205	11	15	133	0	1	99	1
2025	202	202	4	29	119	1	0	102	0
2026	88	88	1	27	61	0	0	33	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

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.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Teralithe, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Teralithe, by the year in which FDA received them
Year	Reports
2004	8
2005	12
2006	12
2007	5
2008	10
2009	15
2010	20
2011	13
2012	12
2013	33
2014	39
2015	32
2016	44
2017	78
2018	154
2019	213
2020	195
2021	145
2022	114
2023	171
2024	208
2025	191
2026	82

Reports that name Teralithe, 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.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Teralithe
Age	Reports	Share
Under 2	20	1.1%
2 to 11	0	0%
12 to 17	12	0.7%
18 to 44	514	28.5%
45 to 64	553	30.6%
65 to 74	304	16.8%
75 and over	188	10.4%
Age not given	215	11.9%

Sex of the patient in the reports that name Teralithe
Sex	Reports	Share
Female	1,109	61.4%
Male	540	29.9%
Unknown or not given	157	8.7%

Type of reporter in the reports that name Teralithe
Reporter	Reports	Share
Physician	747	41.4%
Pharmacist	552	30.6%
Other health professional	338	18.7%
Lawyer	0	0%
Consumer or non-health professional	152	8.4%
Not given	17	0.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Teralithe record
Indication as recorded (MedDRA)	Reports	Share
Bipolar disorder	710	39.3%
Bipolar i disorder	88	4.9%
Schizophrenia	68	3.8%
Toxicity to various agents	53	2.9%
Poisoning deliberate	51	2.8%
Depression	48	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,806 reports.

Drugs in the same reports

Other drugs that the reports of Teralithe name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	111
Clozapine	137
Diazepam	188
Lamotrigine	116
Lorazepam	112
Olanzapine	237
Oxazepam	113
Quetiapine	270
Valium	116
Zopiclone	183

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for TeralitheThe labels (prescribing information) that have this name, at the National Library of Medicine.
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. Teralithe: adverse event reports that FDA received. https://reportedreactions.com/drug/teralithe/ 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.

A report is in the count when it names Teralithe as a suspect or interacting product. The 639 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Teralithe was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
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.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Teralithe?

No. It is a count of what people reported to FDA: 1,806 reports from March 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (41.4%), pharmacist (30.6%) and other health professional (18.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

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