Dafalgan adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Dafalgan /00020001/

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 February 2004 to June 2026, FDA received 1,835 adverse event reports that name Dafalgan. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 7,822 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 66 reports in the 12 months to June 2026 and 64 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Dafalgan 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 15 reports that name Dafalgan.
In January to March 2026, FDA received 13.
In April to June 2025, FDA received 19.

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 275 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 1,819 of the 1,835 reports (99.1%).

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 275 terms.

Reaction terms in the reports that name Dafalgan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,835 reports
Hepatocellular injury	121	6.6%
Agranulocytosis	115	6.3%
Cholestasis	83	4.5%
Somnolencedrowsiness	80	4.4%
Thrombocytopenialow platelets	79	4.3%
Vomitingbeing sick	77	4.2%
Pyrexiafever	71	3.9%
Hepatitis	69	3.8%
Intentional overdosea deliberate overdose	66	3.6%
Drug interactionan interaction between medicines	65	3.5%
Acute kidney injurysudden loss of kidney function	63	3.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	59	3.2%
Nauseafeeling sick	52	2.8%
Suicide attempta suicide attempt	52	2.8%
Gait disturbancedifficulty walking	51	2.8%
Neutropenialow neutrophils, a type of white blood cell	51	2.8%
Falla fall	49	2.7%
Cholestatic liver injury	45	2.5%
Abdominal painstomach or belly pain	44	2.4%
Coma	44	2.4%
Hypotensionlow blood pressure	43	2.3%
Pancytopenialow counts of all blood cells	43	2.3%
Diarrhoealoose or frequent stools	42	2.3%
Leukopenialow white blood cells	39	2.1%
Rash maculo-papulara rash of flat and raised spots	39	2.1%
Anaemialow red blood cells	37	2%
Mixed liver injury	37	2%
Lactic acidosisa build-up of lactic acid in the blood	35	1.9%
Astheniaweakness or lack of energy	34	1.9%
Hepatitis cholestatic	32	1.7%
Jaundiceyellowing of the skin or eyes	32	1.7%
Alanine aminotransferase increasedraised liver enzyme (ALT)	31	1.7%
Confusional stateconfusion	31	1.7%
Decreased appetitereduced appetite	31	1.7%
Drug-induced liver injury	31	1.7%
Transaminases increased	31	1.7%
Bradycardiaslow heart rate	30	1.6%
Analgesic drug level increased	28	1.5%
Aspartate aminotransferase increasedraised liver enzyme (AST)	28	1.5%
Renal failurekidney failure	28	1.5%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	27	1.5%
Eosinophilia	27	1.5%
Overdosea dose above the recommended amount	26	1.4%
Headachehead pain	25	1.4%
Hepatic enzyme increasedraised liver enzymes	25	1.4%
Rhabdomyolysismuscle breakdown	25	1.4%
Condition aggravatedthe condition being treated got worse	24	1.3%
Dyspnoeashortness of breath	24	1.3%
Liver function test abnormal	24	1.3%
Malaisegeneral feeling of being unwell	24	1.3%

Download all 275 terms of Dafalgan (CSV)

The counts add to more than 1,835 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 Dafalgan, 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	20	19	3	1	19	0	0	1	1
2005	23	23	2	0	21	0	0	2	0
2006	20	20	5	1	15	1	0	2	0
2007	22	22	2	2	19	0	0	1	0
2008	37	37	2	5	30	0	0	11	0
2009	80	80	16	3	58	0	0	16	0
2010	60	60	4	3	52	0	1	10	0
2011	33	33	5	4	25	0	0	6	0
2012	21	21	2	0	11	1	0	14	0
2013	116	115	12	11	95	3	0	25	1
2014	78	77	7	9	54	1	1	28	1
2015	112	111	20	4	76	2	9	37	1
2016	91	91	17	19	64	1	0	43	0
2017	101	101	14	6	80	1	2	50	0
2018	177	177	14	22	115	2	0	80	0
2019	173	173	22	10	102	1	2	113	0
2020	134	134	17	29	96	2	0	74	0
2021	96	96	9	19	58	1	0	50	0
2022	122	122	15	9	71	7	0	81	0
2023	104	104	9	9	51	0	0	73	0
2024	99	99	3	15	68	3	0	66	0
2025	76	76	23	13	40	5	0	55	0
2026	40	40	7	7	28	7	2	36	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 Dafalgan, 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 Dafalgan, by the year in which FDA received them
Year	Reports
2004	18
2005	25
2006	20
2007	22
2008	38
2009	80
2010	64
2011	38
2012	37
2013	110
2014	72
2015	121
2016	94
2017	124
2018	184
2019	180
2020	136
2021	94
2022	98
2023	96
2024	85
2025	71
2026	28

Reports that name Dafalgan, 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 Dafalgan
Age	Reports	Share
Under 2	22	1.2%
2 to 11	13	0.7%
12 to 17	64	3.5%
18 to 44	325	17.7%
45 to 64	440	24%
65 to 74	244	13.3%
75 and over	507	27.6%
Age not given	220	12%

Sex of the patient in the reports that name Dafalgan
Sex	Reports	Share
Female	1,003	54.7%
Male	731	39.8%
Unknown or not given	101	5.5%

Type of reporter in the reports that name Dafalgan
Reporter	Reports	Share
Physician	833	45.4%
Pharmacist	215	11.7%
Other health professional	549	29.9%
Lawyer	4	0.2%
Consumer or non-health professional	179	9.8%
Not given	55	3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dafalgan record
Indication as recorded (MedDRA)	Reports	Share
Pain	345	18.8%
Analgesic therapy	35	1.9%
Suicide attempt	32	1.7%
Arthralgia	25	1.4%
Headache	15	0.8%
Back pain	13	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,835 reports.

Drugs in the same reports

Other drugs that the reports of Dafalgan name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	123
Clexane	90
Ibuprofen	130
Kardegic	92
Lyrica	76
Movicol	81
Nexium	176
Novalgin	121
Pantoprazole	127
Xarelto	131

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.

Pages near this one

Dactinomycin next in the A to Z list
Dafalgan Codeine next in the A to Z list
Dacomitinib next in the A to Z list
Daivobet next in the A to Z list
Dacogen next in the A to Z list
Daklinza next in the A to Z list
Daclizumab next in the A to Z list
Daktarin next in the A to Z list
Daclatasvir dihydrochloride next in the A to Z list
Dalacin next in the A to Z list
Daclatasvir next in the A to Z list
Dalacine next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for DafalganThe 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. Dafalgan: adverse event reports that FDA received. https://reportedreactions.com/drug/dafalgan/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Dafalgan as a suspect or interacting product. The 7,822 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 Dafalgan 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 Dafalgan?

No. It is a count of what people reported to FDA: 1,835 reports from February 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 (45.4%), other health professional (29.9%) and pharmacist (11.7%). 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.

To the top of the page