{
 "query": "telmisartan",
 "ingredient": "telmisartan",
 "slug": "telmisartan",
 "rxcui": "73494",
 "brands": [
  "Micardis"
 ],
 "names": [
  "telmisartan"
 ],
 "classes": [
  {
   "id": "C09CA",
   "name": "Angiotensin II receptor blockers (ARBs), plain"
  }
 ],
 "alternatives": [
  "azilsartan medoxomil",
  "candesartan",
  "eprosartan",
  "irbesartan",
  "losartan",
  "olmesartan medoxomil",
  "valsartan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 50
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue telmisartan as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 )",
  "indications_and_usage": "Telmisartan tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors ( 1.2 ) 1.1 Hypertension Telmisartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the...",
  "contraindications": "Telmisartan is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions (6.2) ]. Do not co-administer aliskiren with telmisartan in patients with diabetes. [see Drug interactions(7) ]. Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product ( 4 ) Do not co-administer aliskiren with telmisartan in patients with diabetes ( 4 )",
  "warnings_and_cautions": "Avoid fetal or neonatal exposure ( 5.1 ) Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension ( 5.2 ) Monitor carefully in patients with impaired hepatic ( 5.4 ) or renal function ( 5.5 ) Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker ( 5.6) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue telmisartan as soon as possible [see Use in Specific Populations (8.1) ]. 5.2 Hypotension In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with telmisartan. Either correct this condition prior to administration of telmisartan, or start t...",
  "warnings": "",
  "adverse_reactions": "The following adverse reaction is described elsewhere in labeling: Renal dysfunction upon use with ramipril [see Warnings and Precautions (5.6) ] Hypertension: The most common adverse events (\u22651%) reported in hypertension trials are back pain, sinusitis, and diarrhea ( 6.1 ) Cardiovascular risk reduction: The serious adverse events (\u22651%) reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Hypertension Telmisartan has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy. In placebo-controlled trials...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information) Pregnancy Advise female patients of childbearing age about the consequences of exposure to telmisartan during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Lactation Advise nursing women not to breastfeed during treatment with telmisartan [see Use in Specific Populations (8.2) ] . Symptomatic Hypotension and Syncope Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Advise patients to contact their healthcare provider if syncope occurs [see Warnings and Precautions (5.2) ] . Potassium Supplements Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healt...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension The antihypertensive effects of telmisartan have been demonstrated in six principal placebo controlled clinical trials, studying a range of 20 to 160 mg; one of these examined the antihypertensive effects of telmisartan and hydrochlorothiazide in combination. The studies involved a total of 1773 patients with mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1031 of whom were treated with telmisartan. Following once daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure. Upon initiation of antihypertensive treatment with telmisartan, blood pressure was reduced after the first dose, with a maximal reduction by about 4 weeks. With cessation of treatment with telmisartan tablets, blood pressure gradually returned to baseline values over a period of several days to one week. During long-term studies (without placebo control) the effect of telmisartan appeared to be maintained for up to at ...",
  "brand_name": "telmisartan",
  "manufacturer": "REMEDYREPACK INC.",
  "application_number": "ANDA205150",
  "pharm_class_epc": [
   "Angiotensin 2 Receptor Blocker [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260605",
  "set_id": "09d31eee-cd22-4918-a889-3eb4d2969525",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25288,
  "serious": 21582,
  "death": 2404,
  "hospitalization": 11260,
  "primary_suspect": 25127,
  "top_reactions": [
   [
    "Fatigue",
    1793
   ],
   [
    "Nausea",
    1740
   ],
   [
    "Drug Ineffective",
    1671
   ],
   [
    "Diarrhoea",
    1573
   ],
   [
    "Headache",
    1510
   ],
   [
    "Dyspnoea",
    1466
   ],
   [
    "Fall",
    1433
   ],
   [
    "Off Label Use",
    1424
   ],
   [
    "Dizziness",
    1331
   ],
   [
    "Blood Pressure Increased",
    1312
   ],
   [
    "Arthralgia",
    1309
   ],
   [
    "Malaise",
    1300
   ],
   [
    "Hypertension",
    1258
   ],
   [
    "Asthenia",
    1240
   ],
   [
    "Vomiting",
    1168
   ]
  ],
  "by_year": {
   "2019": 2476,
   "2020": 2487,
   "2021": 2232,
   "2022": 2230,
   "2023": 2028,
   "2024": 2181,
   "2025": 2052,
   "2026": 1090
  },
  "by_year_primary": {
   "2019": 2475,
   "2020": 2480,
   "2021": 2213,
   "2022": 2198,
   "2023": 2009,
   "2024": 2152,
   "2025": 2020,
   "2026": 1070
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20210317",
   "reason": "Labeling: Label-mixup",
   "firm": "Alembic Pharmaceuticals Limited",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 19,
  "nda": 1,
  "anda": 18,
  "first_approval": "19981110",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 1,
  "sponsors": [
   "ADAPTIS",
   "ALEMBIC",
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA",
   "BOEHRINGER INGELHEIM",
   "CADILA PHARMS LTD",
   "CHARTWELL RX",
   "GLENMARK PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/10/1998"
 },
 "trials": {
  "total": 349,
  "completed": 278,
  "terminated": 26,
  "with_results": 65,
  "industry": 257,
  "phase3": 81,
  "results_share": 0.23381294964028776,
  "terminated_share": 0.07449856733524356
 },
 "pubmed": {
  "rct": 289,
  "meta": 31,
  "recent_rct": 27,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "telmisartan",
   "Micardis"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1297548,
  "beneficiaries": 336854,
  "spend": 39420833.160000004,
  "by_brand": [
   {
    "brand": "Telmisartan",
    "claims": 1293200,
    "per_claim": 29.385371327,
    "is_generic": true
   },
   {
    "brand": "Micardis",
    "claims": 4348,
    "per_claim": 326.51126035,
    "is_generic": false
   }
  ],
  "per_claim": 30.38102109517336
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "telmisartan + amlodipine",
  "matched": "telmisartan",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5242,
  "fills": 1297548,
  "per_million": 4039.9276173212857,
  "ratio": 1.4590108079032462,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 57,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "4,040 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 55,
   "letter": "D",
   "why": [
    "289 randomized trials and 31 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 23% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 18 generic makers (-15)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (18 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 71,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, diarrhoea. How would we recognize and handle those?",
  "Why this one over azilsartan medoxomil, candesartan, eprosartan? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}