Drugs › Amide local anesthetic
Brand name · Ropivacaine hydrochloride
Naropin: adverse event reports filed with FDA
706 reports list it as a suspect or interacting product, 2004–2026. Class: Amide local anesthetic. Also reported as Naropin Injection.
- 706
- reports as suspect product
- 0% of all reports · about 32 a year
- 13
- reports, 12 months to June 2026
- 12 in the 12 months before
- 79.7%
- marked serious by the reporter
- 65.1% across the class
- 5.4%
- record death among outcomes, as reported
- 38 reports · not verified by FDA
706 adverse event reports received by FDA list the brand name Naropin (ropivacaine hydrochloride) as a suspect or interacting product, from February 2004 to March 2026. A further 104 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 13 reports listed it, close to the 12 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 32 reports a year and 0% of the 20,646,523 reports in the database, and 1.7% of the reports for the amide local anesthetic class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (10.9%), convulsion (5.4%) and dyspnoea (4.5%). A report can list several reactions, so shares add to more than 100%; 220 different terms appear across these reports. Drug ineffective is recorded in 10.9% of these reports, about the same share as in the median amide local anesthetic drug (11%).
79.7% of the reports are marked serious by the reporter (65.1% across the class); 5.4% record death among the outcomes and 30.3% record hospitalisation, as reported. 37.1% of the reports came from physicians, and the largest patient age group is 45 to 64 (21%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Naropin reports recording the termmedian drug in amide local anesthetic
- Drug ineffectivethe medicine did not work as expected10.9%77
- Convulsion5.4%38
- Dyspnoeashortness of breath4.5%32
- Hypotensionlow blood pressure4%28
- Cardiac arrestthe heart stopped3.8%27
- Anaesthetic complication3.5%25
- Grand mal convulsion3.3%23
- Musculoskeletal painpain in muscles or bones3.3%23
- Loss of consciousnesspassing out3.1%22
- Haematuriablood in the urine3%21
- Oliguria3%21
- Dysphagiadifficulty swallowing2.8%20
- Hypoaesthesianumbness2.8%20
- Staphylococcal infection2.7%19
- Somnolencedrowsiness2.5%18
- Anaphylactic shocka severe allergic reaction with collapse2.3%16
- Cerebral haemorrhage2.3%16
- Epilepsy2.3%16
- Headachehead pain2.3%16
- Overdosea dose above the recommended amount2.3%16
- Platelet count decreasedlow platelet count2.3%16
- Sopor2.3%16
- Medication errora mistake in prescribing, dispensing or taking a medicine2.1%15
- Muscular weaknessmuscle weakness2.1%15
- Bradycardiaslow heart rate2%14
- Drug toxicity2%14
- Lymphopenia1.8%13
- Post procedural complicationa complication after a procedure1.8%13
Top 30 of 220 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the amide local anesthetic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 41,804 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| 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 indication field is filled in by the reporter and is often blank; shares are of all 706 reports.
In context
| Measure | Naropin | Amide local anesthetic | All reports |
|---|---|---|---|
| Reports as suspect product | 706 | 41,804 | 20,646,523 |
| Share of that pool | — | 1.7% | 0% |
| Reports, latest 12 months | 13 | — | 1,332,454 |
| Marked serious | 79.7% | 65.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 54 | 77 | 91 |
| Hospitalisation recorded, per 1,000 reports | 303 | 250 | 213 |
| Consumer-filed share | 7.4% | 27% | 45.8% |
| Top term, share of reports | Drug ineffective 10.9% | median 11% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the amide local anesthetic class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Lidocaine | generic | 13,993 | 1,469 | 80% |
| Bupivacaine | generic | 5,447 | 310 | 83.3% |
| Lidocaine patch | generic | 4,474 | 113 | 4.3% |
| Lidocaine hydrochloride | generic | 3,047 | 314 | 80.7% |
| Exparel | brand | 2,157 | 217 | 42.4% |
| Marcaine | brand | 2,089 | 50 | 44.1% |
| Xylocaine (lidocaine hcl ) | generic | 2,015 | 109 | 89.9% |
| Bupivacaine hcl | generic | 1,870 | 0 | 45.3% |
| Lidocaine hcl | generic | 1,854 | 0 | 49.5% |
| Bupivacaine hydrochloride | generic | 1,797 | 251 | 62.3% |
| Ropivacaine hydrochloride | generic | 1,388 | 300 | 94.2% |
| Lidoderm | brand | 967 | 7 | 45% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Naropin reports
How many adverse event reports has FDA received for Naropin?
706 reports list Naropin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 13 of them arrived in the latest 12 months. Another 104 list it only as a concomitant medication.
What reactions are recorded in Naropin reports?
drug ineffective (10.9%), convulsion (5.4%), dyspnoea (4.5%), hypotension (4%) and renal failure acute (4%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Naropin was responsible.
How serious are the reports?
79.7% are marked serious by the reporter. Among the outcomes recorded, 5.4% of reports include death and 30.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (37.1%), other health professional (34.1%) and pharmacist (13.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Naropin rising?
13 reports in the 12 months to June 2026, close to the 12 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Naropin was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Naropin?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Naropin as a suspect or interacting product; reports listing it only as a concomitant medication (104) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.