Brand name · Ivermectin
Sklice: adverse event reports filed with FDA
516 reports list it as a suspect or interacting product, 2013–2026. Class: Antiparasitic.
- 516
- reports as suspect product
- 0% of all reports · about 40 a year
- 2
- reports, 12 months to June 2026
- 9 in the 12 months before
- 1.4%
- marked serious by the reporter
- 55.8% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
516 adverse event reports received by FDA list the brand name Sklice (ivermectin) as a suspect or interacting product, from August 2013 to March 2026. A further 1 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, 2 reports listed it, down 78% from 9 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 40 reports a year and 0% of the 20,646,523 reports in the database, and 11.4% of the reports for the antiparasitic 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 (50.6%), pruritus (16.3%) and wrong technique in product usage process (6.4%). A report can list several reactions, so shares add to more than 100%; 59 different terms appear across these reports. Drug ineffective is recorded in 50.6% of these reports, a larger share than in the median antiparasitic drug (13.9%).
1.4% of the reports are marked serious by the reporter (55.8% across the class); 0% record death among the outcomes and 0.6% record hospitalisation, as reported. 81.4% of the reports came from consumers, and the largest patient age group is 2 to 11 (9.3%). 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 Sklice reports recording the termmedian drug in antiparasitic
- Drug ineffectivethe medicine did not work as expected50.6%261
- Pruritusitching16.3%84
- Wrong technique in product usage processthe product was used in the wrong way6.4%33
- Product use in unapproved indicationused for a purpose not on the label5.6%29
- Drug administration errora mistake in giving the medicine5%26
- Lice infestation4.3%22
- Product quality issuea problem with the product itself3.7%19
- Formication3.1%16
- Off label useused for a purpose or in a way not on the label2.9%15
- Alopeciahair loss1.2%6
- Hair disorder1.2%6
- Infestation1%5
- Dry skindry skin0.8%4
- Expired product administeredthe product was used past its expiry date0.8%4
- Product use issuea problem in how the product was used0.8%4
- Skin irritationirritated skin0.8%4
- Dandruff0.6%3
- Paraesthesiatingling or pins and needles0.6%3
- Prescribed overdose0.6%3
- Wrong patient received product0.6%3
- Erythemaskin redness0.4%2
- Fatiguetiredness0.4%2
- Feeling abnormalfeeling odd or not right0.4%2
- Ocular hyperaemiaa red eye0.4%2
- Product administration errora mistake in giving the product0.4%2
Top 30 of 59 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 4 drugs in the antiparasitic 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 4,517 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. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Lice infestation | 345 | 66.9% |
| Prophylaxis | 16 | 3.1% |
| Infection parasitic | 4 | 0.8% |
| Acarodermatitis | 2 | 0.4% |
| Hair disorder | 2 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 516 reports.
In context
| Measure | Sklice | Antiparasitic | All reports |
|---|---|---|---|
| Reports as suspect product | 516 | 4,517 | 20,646,523 |
| Share of that pool | — | 11.4% | 0% |
| Reports, latest 12 months | 2 | — | 1,332,454 |
| Marked serious | 1.4% | 55.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 87 | 91 |
| Hospitalisation recorded, per 1,000 reports | 6 | 364 | 213 |
| Consumer-filed share | 81.4% | 33.7% | 45.8% |
| Top term, share of reports | Drug ineffective 50.6% | median 13.9% | 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 antiparasitic class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Stromectol | brand | 1,767 | 19 | 81.3% |
| Ivermectin | generic | 1,577 | 337 | 64% |
| Soolantra | brand | 657 | 5 | 10% |
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 Sklice reports
How many adverse event reports has FDA received for Sklice?
516 reports list Sklice as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 2 of them arrived in the latest 12 months. Another 1 list it only as a concomitant medication.
What reactions are recorded in Sklice reports?
drug ineffective (50.6%), pruritus (16.3%), wrong technique in product usage process (6.4%), product use in unapproved indication (5.6%) and drug administration error (5%). 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 Sklice was responsible.
How serious are the reports?
1.4% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0.6% 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?
consumer or non-health professional (81.4%), other health professional (10.7%) and physician (4.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sklice rising?
2 reports in the 12 months to June 2026, down 78% from 9 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 Sklice 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 Sklice?
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 Sklice as a suspect or interacting product; reports listing it only as a concomitant medication (1) 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.