Adalat adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Adalat
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 January 2004 to June 2026, FDA received 980 adverse event reports that name Adalat. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 6,612 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 13 reports in the 12 months to June 2026 and 4 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, 13 (under 0.1%) name Adalat. Reports from consumers or other non-health professionals were 20.1% of the reports that name Adalat 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 Adalat 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 7 reports that name Adalat.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 2.

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 135 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 964 of the 980 reports (98.4%).

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 135 terms.

Reaction terms in the reports that name Adalat, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 980 reports
Hypotensionlow blood pressure	57	5.8%
Drug interactionan interaction between medicines	39	4%
Blood pressure increaseda raised blood pressure reading	36	3.7%
Hypertensionhigh blood pressure	35	3.6%
Pyrexiafever	33	3.4%
Dyspnoeashortness of breath	30	3.1%
Headachehead pain	27	2.8%
Dizzinesslight-headedness or unsteadiness	26	2.7%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	26	2.7%
Oedema peripheralswelling of the legs, ankles or hands	25	2.6%
Blood pressure decreaseda low blood pressure reading	24	2.4%
Drug ineffectivethe medicine did not work as expected	24	2.4%
Fatiguetiredness	24	2.4%
Shockshock, a collapse of the circulation	23	2.3%
Pruritusitching	22	2.2%
Exposure during pregnancythe medicine was taken during pregnancy	21	2.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	20	2%
Drug exposure during pregnancythe medicine was taken during pregnancy	19	1.9%
Bradycardiaslow heart rate	18	1.8%
Falla fall	17	1.7%
Cheilitis	16	1.6%
Premature babya baby born early	16	1.6%
Caesarean section	15	1.5%
Toxic epidermal necrolysisa severe skin reaction with peeling	15	1.5%
Erythemaskin redness	14	1.4%
Malaisegeneral feeling of being unwell	14	1.4%
Atrioventricular block first degree	13	1.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	13	1.3%
Toxic skin eruption	13	1.3%
Hepatic function abnormal	12	1.2%
Inflammation	12	1.2%
Overdosea dose above the recommended amount	12	1.2%
Product use issuea problem in how the product was used	12	1.2%
Renal failurekidney failure	12	1.2%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	12	1.2%
Acute coronary syndrome	11	1.1%
Acute kidney injurysudden loss of kidney function	11	1.1%
Angina unstable	11	1.1%
Palpitationsawareness of the heartbeat	11	1.1%
Tachycardiafast heart rate	11	1.1%
Abdominal distensiona bloated abdomen	10	1%
Asthma	10	1%
Cerebral infarction	10	1%
Chest pain	10	1%
Exposure via breast milk	10	1%
Liver disorder	10	1%
Loss of consciousnesspassing out	10	1%
Pulmonary oedemafluid in the lungs	10	1%
Rashskin rash	10	1%
Troponin increased	10	1%

Download all 135 terms of Adalat (CSV)

The counts add to more than 980 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 Adalat, 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	46	44	5	6	21	4	0	21	2
2005	52	50	4	11	30	0	0	13	2
2006	75	73	6	7	41	4	0	29	2
2007	84	82	6	23	53	4	0	25	2
2008	65	59	2	15	39	0	1	18	6
2009	53	50	6	2	25	6	1	23	3
2010	44	41	5	4	24	2	0	20	3
2011	23	22	2	4	15	0	0	11	1
2012	39	38	1	2	22	4	0	18	1
2013	32	29	1	3	13	0	1	20	3
2014	47	44	1	6	21	0	1	33	3
2015	78	75	11	8	23	0	0	50	3
2016	81	74	4	15	45	1	1	39	7
2017	47	33	1	1	24	7	0	15	14
2018	65	62	1	8	27	0	0	39	3
2019	40	34	1	4	19	2	0	28	6
2020	18	17	0	2	6	2	0	15	1
2021	17	16	4	1	10	0	0	10	1
2022	14	13	1	0	4	0	0	11	1
2023	30	28	3	6	15	1	0	19	2
2024	10	9	0	2	4	0	0	9	1
2025	6	6	0	1	1	0	0	6	0
2026	14	10	0	1	1	0	0	9	4

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 Adalat, 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 Adalat, by the year in which FDA received them
Year	Reports
2004	41
2005	53
2006	73
2007	85
2008	65
2009	55
2010	47
2011	27
2012	41
2013	32
2014	49
2015	87
2016	76
2017	44
2018	74
2019	38
2020	13
2021	18
2022	10
2023	27
2024	9
2025	6
2026	10

Reports that name Adalat, 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 Adalat
Age	Reports	Share
Under 2	28	2.9%
2 to 11	12	1.2%
12 to 17	6	0.6%
18 to 44	111	11.3%
45 to 64	201	20.5%
65 to 74	195	19.9%
75 and over	201	20.5%
Age not given	226	23.1%

Sex of the patient in the reports that name Adalat
Sex	Reports	Share
Female	494	50.4%
Male	421	43%
Unknown or not given	65	6.6%

Type of reporter in the reports that name Adalat
Reporter	Reports	Share
Physician	364	37.1%
Pharmacist	123	12.6%
Other health professional	208	21.2%
Lawyer	0	0%
Consumer or non-health professional	197	20.1%
Not given	88	9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 8.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Adalat record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	374	38.2%
Essential hypertension	23	2.3%
Raynaud's phenomenon	21	2.1%
Threatened labour	20	2%
Tocolysis	8	0.8%
Arrhythmia	7	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 980 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for AdalatThe 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. Adalat: adverse event reports that FDA received. https://reportedreactions.com/drug/adalat/ 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 Adalat as a suspect or interacting product. The 6,612 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 Adalat 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 Adalat?

No. It is a count of what people reported to FDA: 980 reports from January 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 (37.1%), other health professional (21.2%) and consumer or non-health professional (20.1%). 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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