Skip to the answer

Terbutaline

Terbutaline is a bronchodilator (airway-opener) used to prevent and relieve bronchospasm in people with asthma, bronchitis, and emphysema.

Brand names BrethineBricanyl
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 7 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 →

✓No current FDA shortage listed · checked Oct 7, 2026
Other forms & routes:
Terbutaline at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Terbutaline is an airway-opener that relaxes the muscles around the airways, used to prevent and reverse bronchospasm (sudden airway tightening) in people 12 and older with asthma, bronchitis or emphysema; on the market since about 1974 and available generically, the tablets are now an older standby, usually a backup to inhaled airway-openers, while the faster injection is given by a healthcare provider. Taken by mouth it reaches the whole body, so shakiness, nervousness and a fast or pounding heartbeat are common. Its boxed warning says never use it to stop or prevent preterm labor, especially at home, because pregnant women have had serious heart and lung problems, including deaths.

Clinical pearls

  • If it seems weaker or you need it more often, that signals worsening asthma that may need a steroid controller inhaler.
  • Beta-blockers such as propranolol can cancel terbutaline’s effect and trigger severe bronchospasm, so remind any new prescriber you have asthma.
  • Water pills like furosemide or hydrochlorothiazide can drop potassium further with terbutaline, so your prescriber may check your potassium.
  • Avoid stimulant-type cold medicines such as pseudoephedrine decongestants, which add to terbutaline’s strain on the heart.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Terbutaline must NOT be used to stop preterm labor for more than 48–72 hours, and should never be used at home or on an ongoing basis to prevent preterm labor. This use is not approved and has caused serious harm, including death, in pregnant women. Risks to the mother include a dangerously fast heart rate, low potassium, abnormal heart rhythms, fluid in the lungs, and reduced blood flow to the heart. The baby's heart rate can also increase, and the newborn may have low blood sugar. If you are pregnant and have been given terbutaline for any reason, talk to your doctor about the risks right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Injection
Earliest FDA record1974
Companies listing it with the FDA10
FDA label last updatedNov 15, 2019
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Terbutaline, written from its FDA label.

What Terbutaline is used for

▾

Terbutaline is a bronchodilator approved to prevent and reverse bronchospasm (sudden airway tightening) in patients 12 years and older. It is available as both a tablet and a subcutaneous injection under the Terbutaline Sulfate brand.

  • Asthma — prevention and reversal of bronchospasm (both tablet and injection forms)
  • Bronchitis — reversible bronchospasm associated with chronic bronchitis (both forms)
  • Emphysema — reversible bronchospasm associated with emphysema (both forms)

How Terbutaline works

▾

Terbutaline is a beta-2 adrenergic receptor agonist — meaning it latches on to beta-2 receptors, which are found mainly in the smooth muscle that wraps around your airways. When it activates these receptors, it raises levels of a signaling molecule called cAMP inside the muscle cells. Higher cAMP tells those muscles to relax, which widens the airways and makes breathing easier. It also helps stop airway-irritating substances (like those released from mast cells during an allergic response) from being released.

Because beta-2 receptors also exist in small numbers in the heart, terbutaline can have some cardiovascular effects — particularly at higher doses or with the injection form — so heart rate and blood pressure need to be kept in mind.

Terbutaline dosage

▾

Terbutaline Sulfate Tablets are taken by mouth roughly three times a day during waking hours, spaced about six hours apart. Terbutaline Sulfate Injection is given under the skin (subcutaneous) into the upper arm by a healthcare provider; a second dose may be given if there is no improvement within 15–30 minutes, but the total within 4 hours is capped. There are no food-timing restrictions noted in the labeling for either form.

  • Always follow your prescriber's exact instructions — do not adjust your dose on your own
  • If your medication stops working as well as it used to, call your doctor right away rather than taking extra doses

Dosing details from the FDA-approved label

From the Terbutaline prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults (oral tablets)
    • 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake
    • If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily
    • Maximum: The total dose within 24 hours should not exceed 15 mg
    • Reduced 2.5 mg three times daily dose if side effects are particularly disturbing
  • Children 12 to 15 years of age (oral tablets)
    • 2.5 mg three times daily
    • Maximum: The total dose within 24 hours should not exceed 7.5 mg
    • Not recommended for children below the age of 12 years
  • Subcutaneous injection (usual dose)
    • 0.25 mg injected into the lateral deltoid area
    • If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered
    • If the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered
    • Maximum: The total dose within 4 hours should not exceed 0.5 mg
    • For subcutaneous use only, not intravenous infusion; discard unused portion after single patient use
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Adults The usual oral dose of terbutaline sulfate tablets for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg. Children Terbutaline sulfate tablets are not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12 to 15 years of age. The total dose within 24 hours should not exceed 7.5 mg. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.

Read the full Dosage and Administration section on DailyMed →

Terbutaline side effects

▾

Most side effects of terbutaline are related to its stimulant action and are usually temporary:

Common side effects

  • Tremor (shakiness)
  • Nervousness or anxiety
  • Headache
  • Dizziness
  • Drowsiness
  • Fast or pounding heartbeat (palpitations/tachycardia)
  • Nausea
  • Muscle cramps
  • Palpitations (noticeable heartbeat) or fast heart rate
  • Nausea or vomiting
  • Muscle cramps, dry mouth, or flushing

When to get medical help

  • Call your doctor if you need to use terbutaline more often than usual — this may mean your asthma is getting worse
  • Seek medical help right away if you have chest pain, a very fast or irregular heartbeat, or feel like your heart is pounding hard
  • Tell your doctor if you experience seizures (uncontrolled shaking or loss of consciousness)
  • Get emergency help if you have severe shortness of breath that does not improve after a dose
  • Contact your doctor if you notice significant changes in blood pressure, feel faint, or have unusual sweating with chest discomfort

More serious reactions — including significant changes in heart rate or rhythm, chest discomfort, seizures, or severe shortness of breath — require prompt medical attention. If your usual dose stops relieving symptoms, that is a sign your condition may be worsening and you should call your doctor immediately.

Terbutaline warnings and precautions

▾
  • Worsening asthma: Needing terbutaline more often than usual is a warning sign. Your asthma may be deteriorating and may need a different or additional treatment such as a corticosteroid — don't just take more terbutaline.
  • Heart effects: Terbutaline can raise heart rate, affect blood pressure, and cause ECG (heart tracing) changes. People with coronary artery disease, irregular heart rhythms, or high blood pressure need extra caution.
  • Seizures: Rare cases of seizures have been reported. They stopped when the drug was discontinued.
  • Bronchodilators alone may not be enough: Many asthma patients also need anti-inflammatory therapy (such as inhaled corticosteroids). Talk to your doctor if you rely on terbutaline frequently.
  • Pregnancy — prolonged tocolysis (preterm labor): Terbutaline must never be used to stop preterm labor for more than 48–72 hours or in a home/outpatient setting. Serious risks, including death, have occurred in pregnant women when used this way.

Terbutaline interactions

▾

Terbutaline can interact with several types of medicines — tell your prescriber and pharmacist about everything you take:

  • Other sympathomimetic (stimulant-type) drugs: Combined heart effects can be harmful — avoid using them together
  • MAO inhibitors and tricyclic antidepressants: These can amplify terbutaline's effects on blood vessels; do not use terbutaline within 2 weeks of stopping an MAO inhibitor
  • Beta-blockers (e.g., propranolol, atenolol): These block terbutaline's airway-opening action and can trigger severe bronchospasm in asthma patients — generally should not be combined
  • Non-potassium-sparing diuretics (water pills such as furosemide or hydrochlorothiazide): Can worsen low potassium levels and heart rhythm changes when combined with terbutaline
  • Methylxanthines (e.g., theophylline): Animal studies found a risk of heart arrhythmias and sudden death when combined with beta-agonists — clinical significance in humans is not established, but caution is warranted

Interactions listed in the FDA-approved label

From the Terbutaline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Other sympathomimetic agents: The combined effect on the cardiovascular system may be deleterious to the patient. Concomitant use with terbutaline sulfate injection is not recommended.
  • Monoamine oxidase inhibitors or tricyclic antidepressants: The action of terbutaline on the vascular system may be potentiated. Administer with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of such agents.
  • Beta-blockers (beta-adrenergic receptor blocking agents): They block the pulmonary effect of beta-agonists such as terbutaline and may produce severe bronchospasm in asthmatic patients. Patients with asthma should not normally be treated with beta-blockers; if there is no acceptable alternative, cardioselective beta-blockers could be considered, administered with caution.
  • Nonpotassium-sparing diuretics (such as loop or thiazide diuretics): ECG changes and/or hypokalemia that may result from these diuretics can be acutely worsened by beta-agonists, especially when the recommended beta-agonist dose is exceeded. The clinical significance is not known; caution is advised in coadministration.
Read the label’s full interactions text

Drug Interactions The concomitant use of terbutaline sulfate tablets with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. However, this does not preclude the use of an aerosol bronchodilator of the adrenergic-stimulant type for the relief of an acute bronchospasm in patients receiving chronic oral therapy with terbutaline sulfate tablets.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Terbutaline

▾
  • Tell your doctor if you have any heart condition — including coronary artery disease, irregular heartbeat (arrhythmia), or high blood pressure
  • Tell your doctor if you have a history of seizures
  • Tell your doctor about all medicines you take, especially antidepressants (MAO inhibitors or tricyclics), beta-blockers, or diuretics
  • Pregnant women: terbutaline is not approved for stopping preterm labor and carries serious risks during pregnancy — discuss any use with your doctor immediately
  • Terbutaline tablets and injection are not recommended for children younger than 12 years old
  • Tell your doctor if you are allergic to terbutaline or similar stimulant medicines (sympathomimetic amines)

Terbutaline overdose

▾

Too much terbutaline can cause an exaggerated version of its usual side effects — including a very fast heart rate (up to 200 beats per minute), seizures, chest pain, high or low blood pressure, irregular heart rhythm, severe tremor, nausea, dizziness, and low potassium levels. There is no specific antidote. If an overdose is suspected, seek emergency medical care immediately — treatment focuses on stopping the medication and providing supportive care, including cardiac and respiratory monitoring.

What Terbutaline does in the body

▾

Terbutaline relaxes the smooth muscle around the airways, leading to measurable improvements in airflow. After a subcutaneous injection, a noticeable change in how easily air moves out of the lungs can occur within 5 minutes, with a clinically significant improvement within 15 minutes and the peak effect at 30 to 60 minutes. The bronchodilating benefit from a subcutaneous dose can last between 1.5 and 4 hours. At recommended doses, cardiovascular effects such as increased heart rate can also occur, since beta-2 receptors exist in small numbers in the heart as well.

How your body processes Terbutaline

▾

When taken as a tablet, terbutaline is absorbed over about 1 to 3 hours and has an elimination half-life (the time for the body to clear half the drug) of roughly 3.4 hours in asthma patients. When given as a subcutaneous injection, it is absorbed much faster — peak blood levels occur within about 30 minutes. After injection, about 90% of the drug is eventually excreted in the urine, with the majority leaving the body unchanged. The main metabolite (breakdown product) is a sulfate conjugate. The tablet form shows incomplete absorption in some people, with a portion of the dose eliminated via the stool.

How to store Terbutaline

▾

Store at 20° to 25°C (68° to 77°F) . Dispense in tightly-closed, light-resistant container (USP).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

32

Supplements & herbs that interact with Terbutaline

32 supplements and herbal products have documented interactions with Terbutaline 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 · 1
  • Moderate · 22
  • Minor · 9
Every supplement checked against Terbutaline — ranked by severity The full interaction hub: 1 major · 22 moderate · 9 minor · every one linked to its full report. Check Terbutaline 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.

2

Nutrient depletion considerations

Terbutaline has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 1
See the full Terbutaline nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Terbutaline: pharmacist answers to common questions

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

What is terbutaline actually used for?

▾
Terbutaline is a bronchodilator — it relaxes and opens up the airways in your lungs. It's approved to prevent and relieve bronchospasm (that tight, wheezy feeling when your airways clamp down) in people 12 and older with asthma, chronic bronchitis, or emphysema. It comes as a tablet you take by mouth or an injection that a healthcare provider gives you under the skin.

How quickly does terbutaline work?

▾
The injection form works quite fast — you can notice an improvement in airflow within about 5 minutes, with a more significant benefit kicking in within 15 minutes. The tablet form takes longer, since it's absorbed through your digestive system. If the injection doesn't help within 15 to 30 minutes, a second dose may be given, but if there's still no response after that, your medical team will consider other treatments.

What side effects should I expect — and which ones should make me call my doctor?

▾
The most common things people notice are shakiness (tremor), nervousness, headache, dizziness, and a faster or pounding heartbeat. These are usually temporary and tend to settle down. What you should call your doctor about right away: chest pain or discomfort, a very rapid or irregular heartbeat, a seizure, or shortness of breath that doesn't improve after a dose. And if you find yourself needing terbutaline more often than usual, that's a red flag — call your doctor, because your asthma may be getting worse.

Are there medicines I should avoid while taking terbutaline?

▾
Yes — a few important ones. Beta-blockers (often used for heart conditions or blood pressure, like propranolol) can block terbutaline's effect on your airways and may actually cause severe bronchospasm, so they generally shouldn't be combined. MAO inhibitors and tricyclic antidepressants can amplify terbutaline's effects on your blood vessels — don't use terbutaline within 2 weeks of stopping those. Some water pills (diuretics) can worsen potassium loss and heart rhythm effects when combined with terbutaline. Always tell your prescriber and pharmacist every medicine you take.

I heard terbutaline is used to stop preterm labor. Is that safe?

▾
This is really important: terbutaline is NOT approved for stopping preterm labor, and it should never be used at home or on a long-term basis to prevent it. Using it that way has caused serious harm, including death, in pregnant women — risks include a dangerously fast heart rate, abnormal heart rhythms, low potassium, and fluid on the lungs. Newborns can also be affected. If you're pregnant and have been prescribed terbutaline for any reason, talk to your doctor about the risks right away.

What should I do if my terbutaline tablets stop working as well as they used to?

▾
Don't just take more — contact your doctor right away. If your regular dose isn't giving you the relief it used to, that's often a sign your asthma is getting worse and may need a different or additional treatment, like an anti-inflammatory medicine. Terbutaline alone isn't always enough to control asthma long-term, and your doctor may need to reassess your whole treatment plan.

Is Terbutaline available over the counter?

▾
No. Terbutaline is a prescription medicine: every Terbutaline product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Terbutaline first available?

▾
The earliest FDA record we hold for Terbutaline is from 1974: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Terbutaline was first used.

Who makes Terbutaline?

▾
10 companies currently list Terbutaline products in the FDA's NDC Directory, including ANI Pharmaceuticals, Inc., Amneal Pharmaceuticals of New York LLC, Chartwell RX, LLC.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Terbutaline on HelloPharmacist

Detailed data & references for Terbutaline Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Terbutaline forms and strengths (how it comes)

Terbutaline 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Terbutaline inactive ingredients by manufacturer.

Tablet

By mouth
How this form is used
What it may be used for
  • Terbutaline Sulfate Tablets are used to prevent and reverse bronchospasm in people 12 and older with asthma
  • Terbutaline Sulfate Tablets are used for reversible bronchospasm associated with bronchitis and emphysema
Important instructions
  • Terbutaline Sulfate Tablets are taken by mouth, generally three times daily during waking hours, spaced about six hours apart
  • Terbutaline Sulfate Tablets: the total daily dose should not exceed the amount your prescriber specifies — do not take more than prescribed in any 24-hour period
  • Terbutaline Sulfate Tablets: if side effects are bothersome, your doctor may adjust your dose — never adjust it on your own
  • If Terbutaline Sulfate Tablets stop providing their usual relief, contact your doctor right away — do not simply take more
Available strengths 2 strengths
22 FDA-listed product records ⓘ

Injection

Under the skin
How this form is used
What it may be used for
  • Terbutaline Sulfate Injection is used to prevent and reverse bronchospasm in people 12 and older with asthma
  • Terbutaline Sulfate Injection is used for reversible bronchospasm associated with bronchitis and emphysema
Important instructions
  • Terbutaline Sulfate Injection is given only as a subcutaneous (under-the-skin) injection — it must not be given intravenously (into a vein)
  • Terbutaline Sulfate Injection is injected into the lateral deltoid (upper outer arm) area by a healthcare provider
  • If a meaningful improvement does not occur within 15 to 30 minutes after a Terbutaline Sulfate Injection dose, a second dose may be given — but if there is still no response, other treatments should be considered
  • Terbutaline Sulfate Injection vials are for single patient use — any unused portion should be discarded
Available strengths 1 strength
9 FDA-listed product records ⓘ

Terbutaline on the U.S. market: products, makers and brands

How Terbutaline 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.

10 companies list 17 Terbutaline product records with the FDA, mostly as tablet, injection; the earliest marketing or approval year on record is 1974. Brand names on the directory include Brethine, Bricanyl; the rest are generics.

2
Dose forms ⓘ
10
Labelers (makers, repackagers, distributors)
1
Brand names
17
FDA-listed product records ⓘ
1974
Earliest FDA record ⓘ

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 (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

ANI Pharmaceuticals, Inc.12%
Amneal Pharmaceuticals of New York LLC12%
Chartwell RX, LLC.12%
Hikma Pharmaceuticals USA Inc.12%
Lannett Company, Inc.12%
Proficient Rx LP12%
Other makers29%

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

How widely Terbutaline is used (Medicaid data)

A general measure of how commonly Terbutaline 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 Terbutaline 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.

4,509
Medicaid prescriptions filled (Q1–Q4 2025)
$102,154 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Terbutaline prescribed? Of the 1,601 medications we measure, Terbutaline ranks #1,061 by Medicaid prescriptions — more than 34% of them.

Where Terbutaline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Terbutaline 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 mL / 1 mg/mL injection is the most-dispensed Terbutaline product — about 98% of these Medicaid prescriptions.

1 ML terbutaline sulfate 1 MG/ML Injection Most dispensed

4,399 Medicaid prescriptions (Q1–Q4 2025) 98% of Terbutaline prescriptions shown $98,352 gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857635

terbutaline sulfate 2.5 MG Oral Tablet

75 Medicaid prescriptions (Q1–Q4 2025) 2% of Terbutaline prescriptions shown $1,814 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

Summed across the 2 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857677

terbutaline sulfate 5 MG Oral Tablet

35 Medicaid prescriptions (Q1–Q4 2025) <1% of Terbutaline prescriptions shown $1,989 gross reimbursement (before rebates) ≈ $57 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857683

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 Terbutaline, 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 7 of 50 listed Terbutaline NDCs with Medicaid activity.

Compare Terbutaline products

A representative set of FDA-listed product records for Terbutaline — 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 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Terbutaline NDCs →

Terbutaline side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Terbutaline — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Terbutaline are dyspnoea, asthma, wheezing; about 96% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

1,823
Reports mentioning it
96%
Reported as serious
12
Distinct effects shown
Most reported effects
Dyspnoea
423
Asthma
378
Wheezing
256
Pneumonia
206
Cough
204
Fatigue
148
Loss Of Personal Independence In Daily Activities
140
Therapeutic Product Effect Incomplete
124
Sleep Disorder Due To A General Medical Condition
118
Nasopharyngitis
109
Age groups
Elderly · 123Adult · 120Child · 5Adolescent · 5Infant · 2Neonate · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Terbutaline in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Terbutaline FDA approval history

How Terbutaline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Terbutaline was first approved by the FDA in 1974 (Brand: BRICANYL · Sanofi Aventis Us); the first generic version was approved in 2001. It remains available in U.S. pharmacies today.

1974
Brand approved
Brand: BRICANYL · Sanofi Aventis Us
2001
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Terbutaline recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Terbutaline recalls since July 2021.

✅No Terbutaline recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

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) Terbutaline RxCUI 10368 5 dose forms · 6 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 374041 No current FDA listing
    Clinical drug / strength (SCD) 12 HR terbutaline sulfate 7.5 MG RxCUI 865204
  2. Dose form (SCDF) Injectable Solution RxCUI 374038 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.5 MG/ML RxCUI 857664
  3. Dose form (SCDF) Oral Solution RxCUI 374039 No current FDA listing
    Clinical drug / strength (SCD) sulfate 0.3 MG/ML RxCUI 857660
  4. Dose form (SCDF) Oral Tablet RxCUI 374040 In current FDA listings
    Clinical drug / strength (SCD) sulfate 2.5 MG RxCUI 857677 sulfate 5 MG RxCUI 857683

Look up RxCUI 10368 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.

💵 What Terbutaline costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 2.5 mg $0.947 per tablet NDC details & price history
Tablet · Oral 5 mg $0.638 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Terbutaline brand names

Terbutaline is sold under 2 brand names in the FDA directory — Brethine, Bricanyl. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Brethine Bricanyl

Who makes Terbutaline: manufacturers and labelers

10 companies list Terbutaline products with the FDA. By number of product records, the largest are ANI Pharmaceuticals, Inc., Amneal Pharmaceuticals of New York LLC, Chartwell RX, LLC.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

ANI Pharmaceuticals, Inc. 2 Amneal Pharmaceuticals of New York LLC 2 Chartwell RX, LLC. 2 Hikma Pharmaceuticals USA Inc. 2 Lannett Company, Inc. 2 Proficient Rx LP 2 Upsher-Smith Laboratories, LLC 2 Fresenius Kabi USA, LLC 1 Henry Schein, Inc. 1 Medical Purchasing Solutions. LLC 1

Terbutaline drug class (RxNorm)

Terbutaline belongs to the Selective beta-2-adrenoreceptor agonists class.

Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor agonists

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.

Sources for this Terbutaline page

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 Nov 15, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Terbutaline.
📈
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 Terbutaline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
7
Finished products in the current FDA directory
17
Companies listing them (makers, repackagers, distributors)
10
FDA labeler codes behind them ⓘ
10
Linked representative label ⓘ
ANI Pharmaceuticals, Inc.
Linked label effective
Nov 15, 2019
Composite sections available
18
Linked SPL Set ID
d810a15b-3e10-4f6c-a36e-8ddecbaba9c3
Linked SPL Document ID
ee722f8c-05d6-43bc-825d-9496579032c4
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. ANI Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →