Active ingredient · pooled across combinations
Levamisole Hydrochloride: adverse event reports, pooled
2 ingredient sets in reports · 19 FDA-approved applications in the Green Book
Levamisole Hydrochloride appears, alone or combined with other ingredients, in 245 reports in FDA's animal adverse event database (February 1987 to March 2026). The figures here pool all 2 ingredient sets that include it.
The Green Book lists 19 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
64 reports arrived in the 12 months to March 2026, close to the 63 of the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. That is about 6 reports a year over its reporting history and 0% of all reports.
Pooled across every set, the terms listed most often are death (29.8%), hypersalivation (10.2%) and closure, Abnormal (7.8%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.
Of reports that state seriousness, 46.2% were classed as serious (38.6% across the whole database); 33.9% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.
Ingredient sets that include levamisole hydrochloride
| Active ingredients recorded for the drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Doramectin + Levamisole Hydrochloride | 147 | 60% | 61 |
| Levamisole Hydrochloride | 98 | 40% | 3 |
Ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.
Signs listed in reports, pooled
share of levamisole hydrochloride reports listing the termall reports in the database
- Death29.8%73
- Hypersalivation[drooling]10.2%25
- Closure, Abnormal[a product quality report, not a sign in an animal]7.8%19
- Injection site swelling[swelling where the injection was given]7.8%19
- Inappropriate packaging or design6.1%15
- Lack of efficacy - NOS[the product did not have the expected effect]6.1%15
- Product defect NOS[a product quality report, not a sign in an animal]6.1%15
- Closure, Missing[a product quality report, not a sign in an animal]5.7%14
- Ataxia[unsteady, uncoordinated movement]5.3%13
- Depression[dull, quiet or withdrawn]5.3%13
- Containers, Damaged[a product quality report, not a sign in an animal]4.9%12
- Trembling4.9%12
- Recumbency[lying down and unable or unwilling to rise]4.5%11
- Abortion2.9%7
- Accidental exposure[exposure that was not intended]2.9%7
- Containers, Abnormal[a product quality report, not a sign in an animal]2.9%7
- Convulsion[seizure]2.9%7
- Dyspnoea[difficulty breathing]2.9%7
- Injection site abscess[abscess where the injection was given]2.9%7
- Vomiting2.9%7
- Weakness2.9%7
- Intentional misuse[use that was knowingly different from the label]2.4%6
- Necropsy performed2.4%6
- Administration device NOS, damaged2%5
- Anaphylaxis[sudden severe allergic-type reaction]2%5
- Containers, Leaking[a product quality report, not a sign in an animal]2%5
- Cough2%5
- Injection site lump[lump where the injection was given]2%5
- Lack of efficacy (endoparasite) - NOS[the product did not have the expected effect: target not specified]2%5
- Lack of efficacy (endoparasite) - roundworm NOS[the product did not have the expected effect: roundworms]2%5
Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.
Monthly reports by species, five years
By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcomes, report types and ages
Outcome recorded in the report
What kind of report it was
Age of the animal
Coloured bar: reports naming levamisole hydrochloride. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.
In context
| Measure | Levamisole Hydrochloride | All reports |
|---|---|---|
| Reports | 245 | 1,357,245 |
| Latest 12 months against the 12 before | +2% | -5% |
| Classed serious, of reports stating it | 46.2% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 338.8 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 9% | 23% |
Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.
FDA-approved products containing levamisole hydrochloride (Green Book)
Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.
| Trade name | Active ingredients | Sponsor | Approved for | Application |
|---|---|---|---|---|
| Ripercol L Bolus; Tramisol Cattle Wormer Bolus | Levamisole Hydrochloride | Zoetis Inc. | Cattle | NADA 039-356 |
| Ripercol L Soluble Drench Powder | Levamisole Hydrochloride | Zoetis Inc. | Cattle | NADA 039-357 |
| Ripercol L; Tramisol Soluble Drench Powder for Sheep | Levamisole Hydrochloride | Zoetis Inc. | Sheep | NADA 042-740 |
| Ripercol L Wormer Oblets; Tramisol Sheep Wormer Oblets | Levamisole Hydrochloride | Zoetis Inc. | Sheep | NADA 042-837 |
| Ripercol L | Levamisole Hydrochloride | Zoetis Inc. | Swine | NADA 045-513 |
| Levasole Cattle Wormer Bolus | Levamisole Hydrochloride | Intervet, Inc. | Cattle | NADA 091-826 |
| Ripercol L-Piperazine Soluble | Levamisole Hydrochloride, Piperazine Dihydrochloride | Zoetis Inc. | Horses | NADA 092-237 |
| Ripercol L-Piperazine | Levamisole Hydrochloride, Piperazine Dihydrochloride | Zoetis Inc. | Horses | NADA 093-688 |
| Tramisol | Levamisole Hydrochloride | Zoetis Inc. | Swine | NADA 107-085 |
| Levasole Soluble Pig Wormer | Levamisole Hydrochloride | Intervet, Inc. | Swine | NADA 112-049 |
| Levasole | Levamisole Hydrochloride | Intervet, Inc. | Sheep | NADA 112-050 |
| Levamisole Soluble Drench Powder; Levasole; Levasole Soluble Drench Powder; Tramisol Soluble Drench Powder | Levamisole Hydrochloride | Intervet, Inc. | Cattle, Sheep | NADA 112-051 |
| Levasole Sheep Wormer Bolus; Tramisole Sheep Wormer Oblets Tablets | Levamisole Hydrochloride | Intervet, Inc. | Sheep | NADA 112-052 |
| Tramisol Gel | Levamisole Hydrochloride | Zoetis Inc. | Cattle | NADA 126-237 |
| Prohibit | Levamisole Hydrochloride | Huvepharma EOOD | Cattle, Sheep | ANADA 200-225 |
| LevaMed | Levamisole Hydrochloride | Bimeda Animal Health Ltd. | Swine | ANADA 200-313 |
| LevaMed Soluble Drench Powder | Levamisole Hydrochloride | Bimeda Animal Health Ltd. | Cattle, Sheep | ANADA 200-386 |
| Tramisol Type A Medicated Articleapproval voluntarily withdrawn | Levamisole Hydrochloride | Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc. | Cattle | NADA 044-015 |
| Tramisol Type A Medicated Articleapproval voluntarily withdrawn | Levamisole Hydrochloride | Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc. | Swine | NADA 045-455 |
Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).
Questions about levamisole hydrochloride reports
How many FDA adverse event reports mention levamisole hydrochloride?
245 reports through March 2026, 64 of them in the latest 12 months, counting levamisole hydrochloride alone and in combinations.
Which brands do these reports concern?
That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book reference list on this page names approved products containing levamisole hydrochloride without any counts.
In which combinations is levamisole hydrochloride reported?
Doramectin + Levamisole Hydrochloride (60% of these reports) and Levamisole Hydrochloride (40% of these reports).
What reactions are reported for levamisole hydrochloride?
death (29.8%), hypersalivation (10.2%), closure, Abnormal (7.8%), injection site swelling (7.8%) and inappropriate packaging or design (6.1%). Shares are of reports naming the ingredient; one report can list several terms.
Which animals are these reports about?
cattle (38%), sheep (13.9%) and dog (6.5%).
Does a high count mean levamisole hydrochloride is a problem ingredient?
A count cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." Widely used ingredients collect more reports because more animals receive them.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.