Product name as reported
Nefopam: adverse event reports filed with FDA
948 reports list it as a suspect or interacting product, 2005–2026. Also reported as Nefopam /00396102/.
- 948
- reports as suspect product
- 0% of all reports · about 45 a year
- 114
- reports, 12 months to June 2026
- 111 in the 12 months before
- 99.7%
- marked serious by the reporter
- 57.4% across all reports
- 20.8%
- record death among outcomes, as reported
- 197 reports · not verified by FDA
Between July 2005 and June 2026, 948 adverse event reports received by FDA list the product name "Nefopam" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,633) are left out of every figure here.
In the 12 months to June 2026, 114 reports listed it, close to the 111 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 45 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded acute kidney injury (6.3%), death (5.6%) and drug reaction with eosinophilia and systemic symptoms (5.6%). A report can list several reactions, so shares add to more than 100%; 374 different terms appear across these reports. Acute kidney injury is recorded in 6.3% of these reports, against 0.7% of all reports in the database.
99.7% of the reports are marked serious by the reporter; 20.8% record death among the outcomes and 55.9% record hospitalisation, as reported. 39.6% of the reports came from physicians, and the largest patient age group is 18 to 44 (28.3%). 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 Nefopam reports recording the termall reports in the database
- Acute kidney injurysudden loss of kidney function6.3%60
- Deaththe patient died; cause not stated by this term5.6%53
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement5.6%53
- Dyspnoeashortness of breath4.4%42
- Eosinophilia4.4%42
- Drug interactionan interaction between medicines3.7%35
- Somnolencedrowsiness3.6%34
- Sepsisa severe body-wide response to infection3.5%33
- Thrombocytopenialow platelets3.5%33
- Restlessnessrestlessness3.3%31
- Rash maculo-papulara rash of flat and raised spots3.2%30
- Hepatic cytolysis3.1%29
- Eczemaeczema3%28
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor2.7%26
- Confusional stateconfusion2.6%25
- Pyrexiafever2.6%25
- Agitationrestlessness2.5%24
- Hepatic encephalopathy2.5%24
- Tachycardiafast heart rate2.5%24
- Alveolar lung disease2.4%23
- Diffuse alveolar damage2.4%23
- Eosinophilic pneumonia2.4%23
- Falla fall2.4%23
- Generalised oedema2.4%23
- Glomerular filtration rate decreasedreduced kidney filtering2.4%23
- Hyperammonaemia2.4%23
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2.4%23
- Pulmonary interstitial emphysema syndrome2.4%23
- Rectal haemorrhage2.4%23
- Abdominal painstomach or belly pain2.3%22
Top 30 of 374 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 share of all reports in the database; 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 20,646,523 reports. 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. 0.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pain | 308 | 32.5% |
| Analgesic therapy | 53 | 5.6% |
| Procedural pain | 22 | 2.3% |
| Postoperative analgesia | 17 | 1.8% |
| Analgesic intervention supportive therapy | 16 | 1.7% |
| Anaesthesia | 14 | 1.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 948 reports.
In context
| Measure | Nefopam | All reports |
|---|---|---|
| Reports as suspect product | 948 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 114 | 1,332,454 |
| Marked serious | 99.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 208 | 91 |
| Hospitalisation recorded, per 1,000 reports | 559 | 213 |
| Consumer-filed share | 6.6% | 45.8% |
| Top term, share of reports | Acute kidney injury 6.3% | 0.7% |
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."
Questions about Nefopam reports
How many adverse event reports has FDA received for Nefopam?
948 reports list Nefopam as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 114 of them arrived in the latest 12 months. Another 1,633 list it only as a concomitant medication.
What reactions are recorded in Nefopam reports?
acute kidney injury (6.3%), death (5.6%), drug reaction with eosinophilia and systemic symptoms (5.6%), dyspnoea (4.4%) and eosinophilia (4.4%). 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 Nefopam was responsible.
How serious are the reports?
99.7% are marked serious by the reporter. Among the outcomes recorded, 20.8% of reports include death and 55.9% 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 (39.6%), other health professional (34.8%) and pharmacist (17.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Nefopam rising?
114 reports in the 12 months to June 2026, close to the 111 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 Nefopam 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 Nefopam?
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 Nefopam as a suspect or interacting product; reports listing it only as a concomitant medication (1,633) 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.