Naropin (ropivacaine hydrochloride) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Ropivacaine hydrochloride
Class: Amide local anesthetic
Also reported as: Naropin Injection

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 February 2004 to March 2026, FDA received 706 adverse event reports that name Naropin. In these reports the drug is a suspect or interacting product.

In the same period, 104 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 12 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 Naropin. Reports from consumers or other non-health professionals were 7.4% of the reports that name Naropin 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 Naropin 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 0 reports that name Naropin.
In January to March 2026, FDA received 7.
In April to June 2025, FDA received 8.

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 74 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 667 of the 706 reports (94.5%).

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 74 terms.

Reaction terms in the reports that name Naropin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 706 reports
Drug ineffectivethe medicine did not work as expected	77	10.9%
Convulsion	38	5.4%
Dyspnoeashortness of breath	32	4.5%
Hypotensionlow blood pressure	28	4%
Renal failure acute	28	4%
Cardiac arrestthe heart stopped	27	3.8%
Anaesthetic complication	25	3.5%
Grand mal convulsion	23	3.3%
Musculoskeletal painpain in muscles or bones	23	3.3%
Loss of consciousnesspassing out	22	3.1%
Haematuriablood in the urine	21	3%
Oliguria	21	3%
Dysphagiadifficulty swallowing	20	2.8%
Hypoaesthesianumbness	20	2.8%
Staphylococcal infection	19	2.7%
Somnolencedrowsiness	18	2.5%
Anaphylactic shocka severe allergic reaction with collapse	16	2.3%
Cerebral haemorrhage	16	2.3%
Epilepsy	16	2.3%
Gamma-glutamyltransferase increased	16	2.3%
Headachehead pain	16	2.3%
Overdosea dose above the recommended amount	16	2.3%
Platelet count decreasedlow platelet count	16	2.3%
Sopor	16	2.3%
Medication errora mistake in prescribing, dispensing or taking a medicine	15	2.1%
Muscular weaknessmuscle weakness	15	2.1%
Bradycardiaslow heart rate	14	2%
Drug toxicity	14	2%
Lymphopenia	13	1.8%
Post procedural complicationa complication after a procedure	13	1.8%
Pyrexiafever	12	1.7%
Tachycardiafast heart rate	12	1.7%
Drug exposure during pregnancythe medicine was taken during pregnancy	11	1.6%
Joint injury	11	1.6%
Asthma	10	1.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	10	1.4%
Oedemaswelling from fluid	10	1.4%
Paraplegia	10	1.4%
Pneumonialung infection	10	1.4%
Vomitingbeing sick	10	1.4%
Wheezing	10	1.4%
Drug effect decreasedthe medicine had less effect	9	1.3%
Paraesthesiatingling or pins and needles	9	1.3%
Acute pulmonary oedema	8	1.1%
Agitationrestlessness	8	1.1%
Chondrolysis	8	1.1%
Erythemaskin redness	8	1.1%
Painpain, site not specified	8	1.1%
Product quality issuea problem with the product itself	8	1.1%
Blood pressure decreaseda low blood pressure reading	7	1%

Download all 74 terms of Naropin (CSV)

The counts add to more than 706 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Ropivacaine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ropivacaine	Generic name	1,687
Ropivacaine hydrochloride	Generic name	1,388
Naropin (this page)	Brand name	706

Sum of the separately reported names: 3,781. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Naropin, 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	45	32	6	7	13	14	0	1	13
2005	45	37	3	10	15	7	0	10	8
2006	35	33	1	6	14	9	0	12	2
2007	34	34	2	13	9	7	0	7	0
2008	87	86	7	10	43	12	1	31	1
2009	65	63	3	12	11	18	1	25	2
2010	65	65	2	14	37	8	0	13	0
2011	44	44	3	14	17	2	0	20	0
2012	38	35	2	10	11	4	0	16	3
2013	27	19	1	1	6	4	0	13	8
2014	29	28	3	6	6	2	0	17	1
2015	47	11	4	3	4	0	0	3	36
2016	24	5	1	0	3	0	0	3	19
2017	9	3	0	0	1	0	0	3	6
2018	26	16	0	0	14	0	0	16	10
2019	18	17	0	0	6	0	0	17	1
2020	12	0	0	0	0	0	0	0	12
2021	8	4	0	0	0	0	0	4	4
2022	2	2	0	0	2	0	0	2	0
2023	17	8	0	0	2	0	0	6	9
2024	4	1	0	0	0	0	0	1	3
2025	16	11	0	0	0	0	0	11	5
2026	9	9	0	0	0	0	0	9	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 Naropin, 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 Naropin, by the year in which FDA received them
Year	Reports
2004	42
2005	46
2006	33
2007	37
2008	88
2009	64
2010	66
2011	43
2012	42
2013	26
2014	28
2015	48
2016	22
2017	9
2018	26
2019	18
2020	12
2021	8
2022	4
2023	18
2024	5
2025	14
2026	7

Reports that name Naropin, 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 Naropin
Age	Reports	Share
Under 2	10	1.4%
2 to 11	2	0.3%
12 to 17	7	1%
18 to 44	142	20.1%
45 to 64	148	21%
65 to 74	85	12%
75 and over	67	9.5%
Age not given	245	34.7%

Sex of the patient in the reports that name Naropin
Sex	Reports	Share
Female	377	53.4%
Male	179	25.4%
Unknown or not given	150	21.2%

Type of reporter in the reports that name Naropin
Reporter	Reports	Share
Physician	262	37.1%
Pharmacist	93	13.2%
Other health professional	241	34.1%
Lawyer	14	2%
Consumer or non-health professional	52	7.4%
Not given	44	6.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 36.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Naropin record
Indication as recorded (MedDRA)	Reports	Share
Nerve block	91	12.9%
Epidural anaesthesia	57	8.1%
Local anaesthesia	54	7.6%
Anaesthesia	47	6.7%
Postoperative analgesia	19	2.7%
Musculoskeletal pain	17	2.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 706 reports.

Pages near this one

Ropivacaine same ingredient
Ropivacaine hydrochloride same ingredient
Mepivacaine same class
Menthol same class
Sensorcaine(r) (bupivacaine hci and epinephrine) same class
Marcaine same class
Septocaine and Epinephrine same class
Nardil next in the A to Z list
Nasacort next in the A to Z list
Narcan next in the A to Z list
Nasacort Allergy 24HR next in the A to Z list
Naratriptan next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for NaropinThe 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. Naropin: adverse event reports that FDA received. https://reportedreactions.com/drug/naropin/ 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 Naropin as a suspect or interacting product. The 104 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 Naropin 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 Naropin?

No. It is a count of what people reported to FDA: 706 reports from February 2004 to March 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 (34.1%) and pharmacist (13.2%). 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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