Pet Drug Reports

Ingredients

Active ingredient · pooled across combinations

Levamisole Hydrochloride: adverse event reports, pooled

2 ingredient sets in reports · 19 FDA-approved applications in the Green Book

245reports naming the ingredient, 1987–20260% of all reports · about 6 a year
64reports, 12 months to March 202663 in the 12 months before
46.2%classed serious, as reportedall reports: 38.6%
38%of reports concern cattlesheep 13.9%

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 drugReportsShare of this page's reportsLatest 12 months
Doramectin + Levamisole Hydrochloride14760%61
Levamisole Hydrochloride9840%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

  1. Death29.8%73
  2. Hypersalivation[drooling]10.2%25
  3. Closure, Abnormal[a product quality report, not a sign in an animal]7.8%19
  4. Injection site swelling[swelling where the injection was given]7.8%19
  5. Inappropriate packaging or design6.1%15
  6. Lack of efficacy - NOS[the product did not have the expected effect]6.1%15
  7. Product defect NOS[a product quality report, not a sign in an animal]6.1%15
  8. Closure, Missing[a product quality report, not a sign in an animal]5.7%14
  9. Ataxia[unsteady, uncoordinated movement]5.3%13
  10. Depression[dull, quiet or withdrawn]5.3%13
  11. Containers, Damaged[a product quality report, not a sign in an animal]4.9%12
  12. Trembling4.9%12
  13. Recumbency[lying down and unable or unwilling to rise]4.5%11
  14. Accidental exposure[exposure that was not intended]2.9%7
  15. Containers, Abnormal[a product quality report, not a sign in an animal]2.9%7
  16. Convulsion[seizure]2.9%7
  17. Dyspnoea[difficulty breathing]2.9%7
  18. Injection site abscess[abscess where the injection was given]2.9%7
  19. Intentional misuse[use that was knowingly different from the label]2.4%6
  20. Administration device NOS, damaged2%5
  21. Anaphylaxis[sudden severe allergic-type reaction]2%5
  22. Containers, Leaking[a product quality report, not a sign in an animal]2%5
  23. Injection site lump[lump where the injection was given]2%5
  24. Lack of efficacy (endoparasite) - NOS[the product did not have the expected effect: target not specified]2%5
  25. 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

Dog0 · peak 1
2022202320242025
Cat0 · peak 1
2022202320242025
Horse0 · peak 1
2022202320242025
Other156 · peak 13
Nov 2021: 2Dec 2021: 1Apr 2022: 1May 2022: 1Sep 2022: 1Aug 2023: 4Sep 2023: 2Oct 2023: 4Nov 2023: 4Dec 2023: 1Jan 2024: 3Feb 2024: 3Mar 2024: 2Apr 2024: 9May 2024: 5Jun 2024: 1Jul 2024: 4Aug 2024: 6Sep 2024: 10Oct 2024: 10Nov 2024: 4Dec 2024: 3Jan 2025: 5Feb 2025: 3Mar 2025: 3Apr 2025: 4May 2025: 9Jun 2025: 3Jul 2025: 6Aug 2025: 4Sep 2025: 6Oct 2025: 13Nov 2025: 3Dec 2025: 7Jan 2026: 3Feb 2026: 3Mar 2026: 32022202320242025

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.

033661987: 719871988: 11989: 51990: 1119901991: 41992: 21993: 619931994: 61995: 21996: 1019961997: 11998: 21999: 119992000: 32001: 72003: 220032004: 22005: 32006: 220062007: 52008: 42012: 120122014: 12020: 12021: 320212022: 32023: 152024: 6020242025: 662026: 9

Outcomes, report types and ages

Outcome recorded in the report

Recovered/Normal6.9%17
Recovered with Sequela0%0
Ongoing3.7%9
Died33.5%82
Euthanized0.4%1
Outcome Unknown20.4%50

What kind of report it was

Safety issue62.9%154
Lack of expected effectiveness8.2%20
Both safety and lack of expected effectiveness0.8%2
Manufacturing or product defect28.2%69
Other0%0

Species

Cattle38%93
Sheep13.9%34
Dog6.5%16
Human exposure5.7%14
Goat4.5%11
Pig3.3%8

Age of the animal

Under 1 year13.5%33
1 to 3 years10.6%26
4 to 7 years3.7%9
8 to 11 years0.4%1
12 years and over2.4%6
Age not given69.4%170

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

MeasureLevamisole HydrochlorideAll reports
Reports2451,357,245
Latest 12 months against the 12 before+2%-5%
Classed serious, of reports stating it46.2%38.6%
Death or euthanasia recorded, per 1,000 reports338.863.8
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 nameActive ingredientsSponsorApproved forApplication
Ripercol L Bolus; Tramisol Cattle Wormer BolusLevamisole HydrochlorideZoetis Inc.CattleNADA 039-356
Ripercol L Soluble Drench PowderLevamisole HydrochlorideZoetis Inc.CattleNADA 039-357
Ripercol L; Tramisol Soluble Drench Powder for SheepLevamisole HydrochlorideZoetis Inc.SheepNADA 042-740
Ripercol L Wormer Oblets; Tramisol Sheep Wormer ObletsLevamisole HydrochlorideZoetis Inc.SheepNADA 042-837
Ripercol LLevamisole HydrochlorideZoetis Inc.SwineNADA 045-513
Levasole Cattle Wormer BolusLevamisole HydrochlorideIntervet, Inc.CattleNADA 091-826
Ripercol L-Piperazine SolubleLevamisole Hydrochloride, Piperazine DihydrochlorideZoetis Inc.HorsesNADA 092-237
Ripercol L-PiperazineLevamisole Hydrochloride, Piperazine DihydrochlorideZoetis Inc.HorsesNADA 093-688
TramisolLevamisole HydrochlorideZoetis Inc.SwineNADA 107-085
Levasole Soluble Pig WormerLevamisole HydrochlorideIntervet, Inc.SwineNADA 112-049
LevasoleLevamisole HydrochlorideIntervet, Inc.SheepNADA 112-050
Levamisole Soluble Drench Powder; Levasole; Levasole Soluble Drench Powder; Tramisol Soluble Drench PowderLevamisole HydrochlorideIntervet, Inc.Cattle, SheepNADA 112-051
Levasole Sheep Wormer Bolus; Tramisole Sheep Wormer Oblets TabletsLevamisole HydrochlorideIntervet, Inc.SheepNADA 112-052
Tramisol GelLevamisole HydrochlorideZoetis Inc.CattleNADA 126-237
ProhibitLevamisole HydrochlorideHuvepharma EOODCattle, SheepANADA 200-225
LevaMedLevamisole HydrochlorideBimeda Animal Health Ltd.SwineANADA 200-313
LevaMed Soluble Drench PowderLevamisole HydrochlorideBimeda Animal Health Ltd.Cattle, SheepANADA 200-386
Tramisol Type A Medicated Articleapproval voluntarily withdrawnLevamisole HydrochlorideFort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc.CattleNADA 044-015
Tramisol Type A Medicated Articleapproval voluntarily withdrawnLevamisole HydrochlorideFort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc.SwineNADA 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.