FDA-filed SPL labeling · retrieved through openFDA

Benztropine

Benztropine is a prescription medication used to help manage parkinsonism and to control drug-induced movement side effects (extrapyramidal disorders) caused by certain antipsychotic medications.

Brand name Cogentin
Drug classes ⓘ Anticholinergic
Rx Forms 2 Routes Oral · Intramuscular; Intravenous · Intramuscular, Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 1, 2020
Clinical labels in scope ⓘ31
AvailabilityRx
Earliest approval/marketing year ⓘ1954
FDA-listed product records ⓘ151
Boxed warningNone found in compared labels
How we combine label and product data →
⭐ Benztropine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Benztropine mesylate helps control the tremors and stiffness of parkinsonism and can also calm the abnormal movements that some antipsychotic drugs cause. It works best at the lowest effective dose, adjusted slowly under your doctor's guidance. The most important thing to watch for is overheating — if you stop sweating or feel unusually hot, contact your healthcare provider right away.
How we write & review this content — our editorial policy →

📖 Benztropine: Patient Information Guide

A plain-language walkthrough of Benztropine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Benztropine mesylate is used to help manage movement problems in two main situations:

  • Parkinsonism: Benztropine Mesylate tablets and Benztropine Mesylate injection are both approved as part of the treatment for all forms of parkinsonism — including idiopathic (the most common type), postencephalitic (following a brain infection), and drug-induced parkinsonism.
  • Drug-induced extrapyramidal disorders: Both the tablet and injection forms are used to control abnormal involuntary muscle movements and stiffness triggered by antipsychotic drugs such as phenothiazines. This includes acute reactions that may require rapid treatment.
  • Not for tardive dyskinesia: Benztropine is specifically not approved to treat tardive dyskinesia (the uncontrolled repetitive movements that can develop after long-term antipsychotic use).
⚙️How it works▾

Benztropine works mainly by blocking acetylcholine — a chemical messenger in the brain and nervous system. In parkinsonism, there is an imbalance between acetylcholine and dopamine in the parts of the brain that control movement. By blocking acetylcholine's effects (anticholinergic action), benztropine helps restore that balance and ease symptoms like stiffness and tremor. It also has antihistamine properties similar to older antihistamines, but this effect is not what makes it helpful for parkinsonism.

💊How it's taken▾

Benztropine mesylate is available as an oral tablet and as an injection. The tablet is taken by mouth — once daily (often at bedtime, since its effects last through the night) or in divided doses, depending on what works best for you. The injection is given by a healthcare provider into a muscle or vein and is reserved for situations where oral medication isn't possible or when fast relief is needed.

  • Dosing always starts low and is increased gradually over several days — never jump to a higher dose quickly.
  • Do not stop other Parkinson's medications suddenly when starting benztropine; your doctor will reduce them slowly.
  • Benztropine can be taken with other Parkinson's drugs like levodopa or carbidopa-levodopa — your prescriber will adjust doses as needed.
🤒Side effects — in detail▾

The most common side effects of benztropine are related to its anticholinergic (acetylcholine-blocking) action:

  • Dry mouth — if severe enough to make swallowing or speaking difficult, contact your doctor
  • Constipation
  • Nausea or vomiting
  • Blurred vision and dilated pupils
  • Difficulty urinating
  • Rapid heartbeat (tachycardia)
  • Numbness of fingers
  • Confusion, memory problems, or hallucinations — especially at higher doses

Serious reactions that need prompt medical attention include signs of overheating (hot, dry skin; no sweating; high body temperature), paralytic ileus (gut stops moving), heat stroke, and toxic psychosis (severe confusion or hallucinations).

⚠️Warnings & precautions▾
  • Reduced sweating and overheating: Benztropine can stop you from sweating normally (anhidrosis), which makes it impossible for your body to cool down. This can lead to dangerous overheating (hyperthermia) or fatal heat stroke — especially in hot weather, during physical activity, or if you take other anticholinergic drugs. If you notice you've stopped sweating, seek medical help right away.
  • Serious drug combinations: Taking benztropine with antipsychotics (phenothiazines, haloperidol) or tricyclic antidepressants greatly increases the risk of heat stroke, paralytic ileus, and other life-threatening anticholinergic effects. Report any stomach pain, fever, or heat intolerance to your doctor immediately.
  • Driving and machinery: Benztropine can impair your thinking and physical reactions. Avoid driving or operating dangerous equipment until you know how it affects you.
  • Pregnancy: The safety of benztropine during pregnancy has not been established. Talk to your doctor if you are pregnant or planning to become pregnant.
🔀What it interacts with▾

Benztropine can interact with other medications in ways that increase the risk of serious side effects:

  • Phenothiazines and haloperidol (antipsychotics): Combining these with benztropine raises the risk of heat stroke, paralytic ileus (gut stoppage), and severe anticholinergic toxicity — some cases have been fatal.
  • Tricyclic antidepressants: These also have anticholinergic properties; using them with benztropine amplifies the risk of dangerous overheating, gut problems, and other serious effects.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Children under 3: Benztropine is contraindicated (must not be used) in children younger than 3 years old. It should be used cautiously in older children.
  • Older adults and people with low body weight: These patients tend to be more sensitive and generally cannot tolerate higher doses safely.
  • Hot environments and physical labor: If you work outdoors in heat or do heavy physical work, you face a higher risk of dangerous overheating because benztropine reduces sweating.
  • Chronic illness, alcohol use, or CNS disease: These conditions increase sensitivity to the drug's anticholinergic effects and the risk of overheating.
  • Pregnancy: Safe use during pregnancy has not been established — discuss the risks and benefits with your prescriber.
  • Poor mental outlook or significant psychiatric illness: Patients with these conditions may be poor candidates for benztropine therapy; the drug can worsen confusion and psychotic symptoms.
🚑If you take too much▾

Taking too much benztropine can cause a wide range of serious symptoms, including confusion, hallucinations, agitation, dizziness, muscle weakness, rapid heartbeat, high blood pressure, severe dry mouth, difficulty swallowing, inability to urinate, hot and flushed skin, and in severe cases, seizures, coma, or respiratory arrest. If you suspect an overdose, call emergency services or Poison Control immediately. Medical treatment may include a medication called physostigmine salicylate to reverse anticholinergic effects, along with supportive care tailored to the specific symptoms.

📡Pharmacodynamics — effects in the body▾

Benztropine blocks the action of acetylcholine (an anticholinergic effect), which helps rebalance the brain chemistry disrupted in parkinsonism. This leads to reduced muscle stiffness, tremors, and involuntary movements. It also has antihistamine effects similar to older antihistamine drugs, though this property is not considered clinically meaningful for treating parkinsonism.

📦How to store it▾

Dispense in a well-closed container as defined in the USP. Store at 20° to 25°C (68° to 77°F) .

📄 Written from Benztropine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

46

Supplements & herbs that interact with Benztropine

46 supplements and herbal products have documented interactions with Benztropine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 32
  • Minor · 11
ACTIVATED CHARCOAL Major HENBANE Major SCOPOLIA Major ANGEL'S TRUMPET Moderate BACOPA Moderate BELLADONNA Moderate BETEL NUT Moderate BOXWOOD Moderate +38 more
Every supplement checked against Benztropine — ranked by severity The full interaction hub: 3 major · 32 moderate · 11 minor · every one linked to its full report. Check Benztropine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Benztropine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is benztropine supposed to do for me? ▾
Benztropine helps reduce the stiffness, tremors, and movement problems that come with parkinsonism. It works by blocking certain chemical signals in the brain that are out of balance in that condition. It's used alongside other treatments — it's not a standalone cure, but it can make daily life a lot more manageable. It's also used when certain antipsychotic medications cause unwanted muscle side effects.
Should I take my tablet in the morning or at night? ▾
This medication has a long-lasting effect, so many people do best taking their full dose at bedtime — it can help you move more comfortably during the night and make it easier to get up in the morning. That said, some people feel better splitting it into smaller doses two to four times a day. Your prescriber will work with you to find the timing that gives you the best relief, so stick with the schedule they recommend.
What side effects should I actually expect — and which ones should make me call my doctor? ▾
The most common ones are dry mouth, constipation, blurred vision, and sometimes nausea — these are related to how the drug works and are usually manageable. The ones you should call your doctor about right away are stopping sweating (that's a red flag for dangerous overheating), signs of heat stroke like hot dry skin or confusion, severe belly pain that could mean your gut has stopped working, or new confusion and hallucinations. Don't wait on those — they need prompt attention.
Can I stop taking my other Parkinson's medications now that I'm starting benztropine? ▾
No — please don't stop them abruptly. Stopping other Parkinson's medications suddenly can cause a significant worsening of your symptoms. If your doctor wants to reduce or stop them, that has to be done gradually and under their supervision. Benztropine is often used alongside other Parkinson's drugs, like levodopa, and your doctor will adjust everything together.
Is it safe to be outside in the heat while taking this medication? ▾
You need to be careful. Benztropine can reduce your ability to sweat, which means your body has a harder time cooling itself down in hot weather. Heat stroke — which can be serious or even fatal — is a real risk, especially if you're also taking antipsychotics or antidepressants. Try to stay cool, avoid strenuous outdoor activity on hot days, and if you notice you've stopped sweating or feel unusually hot and flushed, get medical help right away.
Is this medication safe to take during pregnancy? ▾
The safety of benztropine during pregnancy hasn't been established, so this is an important conversation to have with your prescriber. They'll weigh the benefits against the potential risks for you and your baby. Don't stop or start anything on your own — your doctor needs to be part of that decision.
Is Benztropine available over the counter? ▾
Benztropine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Benztropine first available? ▾
Benztropine has been available in the United States since at least 1954, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Benztropine? ▾
Benztropine is supplied by 36 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack, American Health Packaging.

💬 Answers drafted from Benztropine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Benztropine supplement interactions46 checked — ranked by severity 🌿Drug & Supplement CheckerBenztropine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Benztropine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Benztropine comes

Benztropine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Benztropine Mesylate tablets are used as part of the treatment for all forms of parkinsonism
  • Benztropine Mesylate tablets are used to control drug-induced extrapyramidal disorders (abnormal muscle movements) caused by antipsychotics such as phenothiazines — but not tardive dyskinesia
Important instructions
  • Benztropine Mesylate tablets should be used when a patient is able to swallow oral medication
  • The dose is started low and increased slowly every five to six days until the best response is reached — follow your prescriber's schedule exactly
  • Some patients do best taking the full daily dose at bedtime; others do better with doses split two to four times a day — your prescriber will advise which works for you
  • Do not stop other Parkinson's medications abruptly when starting Benztropine Mesylate tablets — any changes must be made gradually under your doctor's guidance
Available strengths 3 strengths
0.5 mg 1 mg 2 mg
131 FDA-listed product records ⓘ

Injection

Into a muscle · Into a vein
How this form is used
What it may be used for
  • Benztropine Mesylate injection is used as part of the treatment for all forms of parkinsonism
  • Benztropine Mesylate injection is used to control drug-induced extrapyramidal disorders caused by antipsychotics — but not tardive dyskinesia
  • Benztropine Mesylate injection is used in emergency situations when rapid relief of severe parkinsonian symptoms is needed
Important instructions
  • Benztropine Mesylate injection is given by a healthcare provider into a muscle (intramuscular) or into a vein (intravenous); improvement can be noticeable within a few minutes
  • There is no meaningful difference in how fast the intramuscular and intravenous routes work, so the intravenous route is not usually necessary
  • Benztropine Mesylate tablets should be used in place of the injection as soon as the patient is able to take oral medication
  • Dosing is started low and increased gradually every five to six days — the prescriber determines the right amount based on the patient's age, weight, and type of parkinsonism
Available strengths 1 strength
1 mg/mL
13 FDA-listed product records ⓘ

📊 Benztropine across the U.S. market

How Benztropine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
36
Manufacturers
1
Brand names
151
FDA-listed product records ⓘ
1954
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.15%
Bryant Ranch Prepack10%
American Health Packaging9%
Par Pharmaceutical, Inc.6%
Major Pharmaceuticals6%
Chartwell RX, LLC.5%
Other makers50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Benztropine is used

A general measure of how commonly Benztropine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Benztropine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,314,428
Medicaid prescriptions filled (Q1–Q4 2025)
$15.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Benztropine prescribed? Of the 1,596 medications we measure, Benztropine ranks #141 by Medicaid prescriptions — more than 91% of them.

Where Benztropine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #141 of 1,596
#136 Chlorhexidine 1,373,852 Rx #137 Simvastatin 1,357,663 Rx #138 Tretinoin 1,345,058 Rx #139 Tretinoin Topical 1,344,781 Rx #140 Dapagliflozin 1,339,664 Rx #141 Benztropine 1,314,428 Rx #142 Diphenhydramine 1,303,409 Rx #143 Dexamethasone Injectio... 1,290,031 Rx #144 Ketorolac Injection 1,259,288 Rx #145 Dicyclomine 1,233,412 Rx #146 Albuterol and Ipratrop... 1,217,671 Rx

Utilization by Benztropine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg oral tablet is the most-dispensed Benztropine product — about 54% of these Medicaid prescriptions.

benztropine mesylate 1 MG Oral Tablet Most dispensed

704,240 Medicaid prescriptions (Q1–Q4 2025) 54% of Benztropine prescriptions shown $8.2M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 14 of 74 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 885213

benztropine mesylate 0.5 MG Oral Tablet

403,546 Medicaid prescriptions (Q1–Q4 2025) 31% of Benztropine prescriptions shown $4.6M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 11 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 885219

benztropine mesylate 2 MG Oral Tablet

205,972 Medicaid prescriptions (Q1–Q4 2025) 16% of Benztropine prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 13 of 58 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 885209

2 ML benztropine mesylate 1 MG/ML Injection

670 Medicaid prescriptions (Q1–Q4 2025) <1% of Benztropine prescriptions shown $78,175 gross reimbursement (before rebates) ≈ $117 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 885205

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Benztropine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 40 of 195 listed Benztropine NDCs with Medicaid activity.

🔍 Compare Benztropine products

A representative set of FDA-listed product records for Benztropine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 151 of 151 products — FDA National Drug Code Directory. See every product, package size and price: browse all 151 Benztropine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Benztropine RxCUI 1424 2 dose forms · 4 strengths

Look up RxCUI 1424 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Cogentin

🏭 Manufacturers & labelers

Remedyrepack Inc. 22 Bryant Ranch Prepack 15 American Health Packaging 13 Par Pharmaceutical, Inc. 9 Major Pharmaceuticals 9 Chartwell RX, LLC. 8 NCS HealthCare of KY, LLC dba Vangard Labs 6 A-S Medication Solutions 6 Hikma Pharmaceuticals USA Inc. 5 Coupler LLC 5 Navinta LLC 3 Zydus Pharmaceuticals USA Inc. 3 Sunrise Pharmaceutical, Inc 3 ScieGen Pharmaceuticals Inc 3 Quagen Pharmaceuticals Llc 3 Aphena Pharma Solutions - Tennnessee, LLC 3 NCS HealthCare of KY, Inc dba Vangard Labs 3 Marlex PHARMACEUTICAL, INC 3 Bayshore Pharmaceuticals LLC (NJ) 3 Leading Pharma, LLC 3 Endo USA, Inc. 3 Cipla USA Inc. 3 Fresenius Kabi USA, LLC 2 Direct Rx 2

…and 12 more on the FDA NDC directory.

RxNorm drug class

Benztropine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic, Antihistamine
Drug family (ATC) Ethers of tropine or tropine derivatives
How it works Histamine Receptor Antagonists, Cholinergic Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 1, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Benztropine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Benztropine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
31
NDC products indexed
151
Distinct labelers/manufacturers represented
36
Linked representative label ⓘ
Cipla USA Inc.
Linked label effective
May 1, 2020
Composite sections available
13
Linked SPL Set ID
3d2732f9-b8a9-4e83-91e7-da616ddcb786
Linked SPL Document ID
3d362141-de53-4949-b9a5-34f2b7bb0e75
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 31 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.