This page reprints a manufacturer label. Everything below in quotation marks is copied from Semintra® (telmisartan oral solution) 10 mg/mL, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for Semintra® (telmisartan oral solution) 10 mg/mL by Boehringer Ingelheim Animal Health USA Inc, a telmisartan product labelled for cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.
The label
Product: Semintra® (telmisartan oral solution) 10 mg/mL. Manufacturer: Boehringer Ingelheim Animal Health USA Inc. FDA Structured Product Label set id f436a826-9f5b-4269-b4ec-97d5522eaca6. Label effective 2021-08-25. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
SEMINTRA is indicated for the control of systemic hypertension in cats.
Dosage and Administration
Always provide the Client Information Sheet with each prescription. The initial dose of SEMINTRA is 1.5 mg/kg (0.68 mg/lb) orally twice daily for 14 days, followed by 2 mg/kg (0.91 mg/lb) orally once daily. The dose may be reduced by 0.5 mg/kg (0.23 mg/lb) increments to a minimum of 0.5 mg/kg (0.23 mg/lb) orally once daily to manage SEMINTRA-induced hypotension. SEMINTRA can be administered directly into the mouth, or next to or on top of a small amount of food. Do not mix into food. SEMINTRA should be administered using the dosing syringe provided in the package. The dosing syringe fits onto the bottle and has 0.1 mL incremental marks. The dose should be rounded to the nearest 0.1 mL. After administration close the bottle tightly with the cap. Rinse the dosing syringe with water and let air dry. If the cat vomits within 30 minutes of dosing, the cat may be re-dosed.
Contraindications
Do not use in cats with a hypersensitivity to telmisartan. Human Warnings: Not for human use. Keep out of reach of children. SEMINTRA is an angiotensin II antagonist/angiotensin receptor blocker (ARB). Pregnant women should avoid contact with SEMINTRA because substances that act on the renin-angiotensin-aldosterone system (RAAS) such as angiotensin receptor blockers (ARBs) can cause fetal and neonatal morbidity and death during pregnancy in humans.
Precautions
SEMINTRA has not been evaluated in cats with systolic blood pressure >200 mm Hg. SEMINTRA can cause mild anemia or non-regenerative anemia. Cats should be monitored for anemia when initiating treatment with SEMINTRA. SEMINTRA may cause inappetence and weight loss in some cats. Cats should be monitored for weight loss when initiating treatment with SEMINTRA. Use with caution in cats with a history of vomiting, inappetence or weight loss. The safe use of SEMINTRA in cats with hepatic disease has not been evaluated. SEMINTRA is metabolized by the liver. The safe use of SEMINTRA has not been evaluated in cats less than 9 months of age. The safe use of SEMINTRA has not been evaluated in cats that are pregnant, lactating, or intended for breeding. See Human Warnings . The safe use with other anti-hypertensive medications has not been evaluated.
Adverse Reactions
28-day Field Effectiveness Study Safety was evaluated in a 28-day field study in 288 cats (192 SEMINTRA group cats, 96 control group cats) that received at least one dose of study drug. The control product was a vehicle control without telmisartan. Cats enrolled in the study had a median age of 14 years (7-20 years), and weighed 1.93-11.4 kg. SEMINTRA was administered orally at 1.5 mg/kg twice daily for 14 days, then 2 mg/kg once daily until study end; the control was administered at a volume equivalent to SEMINTRA. One hundred fourteen (59.4%) SEMINTRA group cats and 42 (43.8%) control group cats had at least one adverse reaction. Adverse reactions that occurred in at least 5% of either treatment group are presented in Table 1 below. Table 1 Adverse Reactions in the 28-Day Field Study Clinical Sign SEMINTRA N=192 Control N=96 Vomiting 46 (24.0%) 14 (14.6%) Diarrhea 18 (9.4%) 4 (4.2%) Lethargy 13 (6.8%) 3 (3.1%) Weight loss 13 (6.8%) 5 (5.2%) Decreased appetite/inappetence 13 (6.8%) 7 (7.3%) Non-regenerative anemia 11 (5.7%) 2 (2.1%) Dehydration 10 (5.2%) 4 (4.2%) Retinal lesions (target organ damage) 4 (2.1%) 6 (6.3%) Additional adverse reactions that occurred in <5% of the SEMINTRA group included (in order of decreasing frequency): anorexia, gagging, arrhythmia, cough, heart murmur, and regenerative anemia. Additional adverse reactions representing 2-5% of the control group included azotemia, not drinking and renal failure. Seven cats (five SEMINTRA and two control) either died or were euthanized during the study. None of the SEMINTRA group deaths were considered related to treatment. 5-month Field Effectiveness and Safety Study The long-term safety of SEMINTRA was evaluated in an open label, 5 month field effectiveness and safety study in 107 cats that received at least one dose of SEMINTRA. Cats enrolled in the study had a mean age of 14.1 years (7-20 years) and weighed 1.92-11.4 kg. SEMINTRA was administered orally at 2 mg/kg once daily. Ninety-four cats (87.9%) had at least one adverse reaction during the study. Adverse reactions that occurred in at least 5% of cats are presented in Table 2 below. Table 2 Adverse Reactions in the 5-Month Study Clinical Sign SEMINTRA N=107 Weight loss 37 (34.6%) Vomiting 32 (29.9%) Dehydration 18 (16.8%) Non-regenerative anemia 17 (15.8%) Anorexia 14 (13.1%) Diarrhea 12 (11.2%) Lethargy 12 (11.2%) Decreased appetite/inappetence 11 (10.3%) Heart murmur 10 (9.3%) Death, Euthanasia, Found dead 9 (8.4%) Cough 8 (7.5%) Retinal lesions (target organ damage) 6 (5.6%) Adverse reactions representing <5% of the study population were (in order of decreasing frequency): elevated liver enzymes, renal failure, tachycardia, arrhythmia, azotemia, depression, loose stool, constipation, gagging, hypotension, regenerative anemia, renal insufficiency, and vocalization. Nine cats died or were euthanized during the study. Three cats had progressive chronic kidney disease that may have been affected by telmisartan treatment, concurrent disease, or inadequate control of hypertension. The other six cats died of causes unrelated to treatment (e.g. neoplasia). To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
Description
SEMINTRA (telmisartan oral solution) is a clear, colorless to yellowish viscous solution containing 10 mg/mL telmisartan. Telmisartan is an orally active, non-peptide, selective angiotensin II subtype 1 (AT1) receptor blocker. The chemical name of telmisartan is 4'-[(1,4’-dimethyl-2'propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Image of Structural Formula
Information for Owners
Always provide the Client Information Sheet with each prescription and review it with the cat owner. Advise cat owners that adverse reactions can occur with use of SEMINTRA. The most common adverse reactions reported during the field studies included vomiting, diarrhea, lethargy, weight loss, anemia and dehydration.
Storage
Store at or below 25°C (77°F) with excursions permitted up to 40°C (104°F). Once the bottle is opened, use the contents within six months.
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming telmisartan as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Cats: 420 reports
| VeDDRA reaction term | Reports |
|---|---|
| Lack of efficacy - NOS | 106 |
| Vomiting | 99 |
| Weight loss | 45 |
| Decreased appetite | 32 |
| Elevated creatinine | 30 |
| Death by euthanasia | 28 |
| Dehydration | 27 |
| Diarrhoea | 25 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 24 |
| Inappetence | 19 |
| Anaemia NOS | 18 |
| Heart murmur | 17 |
| Urinary tract infection | 17 |
| Constipation | 16 |
| Dental disease | 14 |
Outcome as recorded by the reporter: Outcome Unknown 254; Recovered/Normal 85; Ongoing 44; Euthanized 30; Died 7.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Semintra® (telmisartan oral solution) 10 mg/mLFDA · retrieved 2026-09-16
“Always provide the Client Information Sheet with each prescription.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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