Drugs › Standardized chemical allergen
Generic name
Isopropyl alcohol: adverse event reports filed with FDA
2,966 reports list it as a suspect or interacting product, 2005–2026. Class: Standardized chemical allergen.
- 2,966
- reports as suspect product
- 0% of all reports · about 143 a year
- 645
- reports, 12 months to June 2026
- 1,177 in the 12 months before
- 99.3%
- marked serious by the reporter
- 98.7% across the class
- 71%
- record death among outcomes, as reported
- 2,105 reports · not verified by FDA
Between October 2005 and March 2026, 2,966 adverse event reports received by FDA list isopropyl alcohol, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (574) are left out of every figure here.
In the 12 months to June 2026, 645 reports listed it, down 45% from 1,177 in 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 143 reports a year and 0% of the 20,646,523 reports in the database, and 40.6% of the reports for the standardized chemical allergen class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are pemphigus (45.9%), glossodynia (45.6%) and hand deformity (45.1%). A report can list several reactions, so shares add to more than 100%; 382 different terms appear across these reports. Pemphigus is recorded in 45.9% of these reports, a larger share than in the median standardized chemical allergen drug (28.9%).
99.3% of the reports are marked serious by the reporter (98.7% across the class); 71% record death among the outcomes and 72.8% record hospitalisation, as reported. 85.8% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (54.1%). 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 Isopropyl alcohol reports recording the termmedian drug in standardized chemical allergen
- Pemphigus45.9%1,360
- Glossodynia45.6%1,352
- Hand deformity45.1%1,337
- Helicobacter infection45%1,335
- Joint swellinga swollen joint44.9%1,331
- Infusion related reactiona reaction during or soon after an infusion44.7%1,325
- Systemic lupus erythematosuslupus, an autoimmune disease44.7%1,325
- Impaired healingslow healing44.6%1,322
- Pericarditisinflammation of the sac around the heart44.6%1,322
- Irritable bowel syndrome44.5%1,320
- Folliculitis44%1,306
- Rashskin rash43.8%1,299
- Hypersensitivityan allergic-type reaction43.8%1,298
- Painpain, site not specified43.6%1,293
- Wound43.6%1,293
- Hepatic enzyme increasedraised liver enzymes43.5%1,289
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease42.1%1,250
- Swellingswelling42.1%1,250
- Fatiguetiredness42%1,247
- Synovitis41.9%1,244
- Confusional stateconfusion41.9%1,243
- Duodenal ulcer perforation41.4%1,229
- Injurya physical injury40.9%1,213
- Alopeciahair loss40.4%1,197
- Abdominal discomfortstomach discomfort39.3%1,167
- Nasopharyngitisa cold39.3%1,166
- Weight increasedweight gain39.2%1,162
- Blistera blister38.9%1,153
- Ill-defined disordera condition that was not clearly described38.7%1,149
- Dyspnoeashortness of breath38.5%1,142
Top 30 of 382 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 2 drugs in the standardized chemical allergen 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 7,314 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. 2.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Rheumatoid arthritis | 181 | 6.1% |
| Foetal exposure during pregnancy | 58 | 2% |
| Infection prophylaxis | 4 | 0.1% |
| Psoriasis | 4 | 0.1% |
| Constipation | 3 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,966 reports.
In context
| Measure | Isopropyl alcohol | Standardized chemical allergen | All reports |
|---|---|---|---|
| Reports as suspect product | 2,966 | 7,314 | 20,646,523 |
| Share of that pool | — | 40.6% | 0% |
| Reports, latest 12 months | 645 | — | 1,332,454 |
| Marked serious | 99.3% | 98.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 710 | 438 | 91 |
| Hospitalisation recorded, per 1,000 reports | 728 | 554 | 213 |
| Consumer-filed share | 3.1% | 12.4% | 45.8% |
| Top term, share of reports | Pemphigus 45.9% | median 28.9% | 0.1% |
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 standardized chemical allergen class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Gold | generic | 4,348 | 325 | 98.3% |
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 Isopropyl alcohol reports
How many adverse event reports has FDA received for Isopropyl alcohol?
2,966 reports list Isopropyl alcohol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 645 of them arrived in the latest 12 months. Another 574 list it only as a concomitant medication.
What reactions are recorded in Isopropyl alcohol reports?
pemphigus (45.9%), glossodynia (45.6%), hand deformity (45.1%), helicobacter infection (45%) and joint swelling (44.9%). 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 Isopropyl alcohol was responsible.
How serious are the reports?
99.3% are marked serious by the reporter. Among the outcomes recorded, 71% of reports include death and 72.8% 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?
other health professional (85.8%), physician (10.5%) and consumer or non-health professional (3.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Isopropyl alcohol rising?
645 reports in the 12 months to June 2026, down 45% from 1,177 in 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 Isopropyl alcohol 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 Isopropyl alcohol?
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 Isopropyl alcohol as a suspect or interacting product; reports listing it only as a concomitant medication (574) 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.