Skip to the answer

Theophylline

Theophylline is a bronchodilator used to treat symptoms and breathing difficulties associated with chronic asthma and other chronic lung diseases such as emphysema and chronic bronchitis.

Brand names UniphylTheolairElixophyllinTheochronQuibron-T +11 more
Drug classes Methylxanthine
Rx Forms 3
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 33 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 8, 2026 🚨Recall on record · 2
Theophylline 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

Theophylline is an older standby for chronic asthma, emphysema and chronic bronchitis that relaxes the muscles around the airways and calms their overreaction to triggers; it has been on the market since the 1940s, is available as a generic, and today is usually added on when inhalers alone are not enough. Many people notice caffeine-like effects, such as nausea, jitteriness or trouble sleeping. The big catch is a narrow margin between a helpful dose and a harmful one, so regular blood level checks are essential, and a seizure, nonstop vomiting or a racing, irregular heartbeat needs urgent care. Illness, fever and new medicines can all push levels up.

Clinical pearls

  • Theophylline will not stop a sudden asthma attack, so keep your rescue inhaler close for quick relief.
  • Take Theo-24 each morning at about the same time so your blood level stays steady.
  • Tell every prescriber you take it, since erythromycin and cimetidine can push levels up and rifampin can drop them.
  • Large diet shifts change your levels, with high-protein or charcoal-broiled foods lowering them and high-carb, low-protein eating raising them.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asExtended-release tablet, Oral solution, Extended-release capsule
Earliest FDA record1947
Companies listing it with the FDA26
FDA label last updatedOct 7, 2024
FDA’s strongest warning (boxed)None on the label

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

What Theophylline is used for

▾

Theophylline is a bronchodilator approved to treat symptoms and reversible airflow obstruction linked to chronic lung conditions. All supported formulations — Theo-24 extended-release capsules, Theophylline extended-release tablets, and Elixophyllin/Theophylline oral solution — share these indications:

  • Chronic asthma — long-term symptom management and breathing improvement
  • Emphysema — a chronic lung disease that traps air and damages air sacs
  • Chronic bronchitis — long-term inflammation and narrowing of the breathing tubes

Theophylline is for ongoing symptoms. It is not for sudden, acute breathing attacks, which need faster-acting treatments.

How Theophylline works

▾

Theophylline opens up narrowed airways by relaxing the smooth muscle wrapped around them — a process called bronchodilation. It also helps calm the airways' oversensitivity to irritants and triggers. On top of that, it strengthens the diaphragm, your main breathing muscle, so each breath takes less effort.

Blood levels matter a great deal with this drug. Bronchodilation occurs within a specific concentration range, and once levels climb too high, the risk of serious side effects rises sharply. This is why regular blood-level monitoring is a core part of theophylline therapy.

Theophylline dosage

▾

Theophylline is taken by mouth in three forms: extended-release capsules (Theo-24), extended-release tablets, and an oral solution (Elixophyllin). Extended-release forms are designed for once- or twice-daily dosing to maintain steady levels throughout the day. Theo-24 is typically taken once each morning; when twice-daily dosing is needed, the second dose should be taken 10–12 hours after the morning dose and before the evening meal — not at night.

  • Theo-24 is not recommended as a once-daily product taken at nighttime due to differences in overnight absorption
  • Food and diet can affect how quickly theophylline is absorbed and cleared — discuss any major diet changes with your provider
  • Never skip or double doses without guidance; blood levels should be checked regularly to keep you in the safe range

Dosing details from the FDA-approved label

From the Theophylline 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.

  • Children 12-15 years of age with risk factors for reduced theophylline clearance, or when it is not feasible to monitor serum theophylline concentrations
    • The theophylline dose should not exceed 16 mg/kg/day
    • Maximum: 400 mg/day
    • Applies in the presence of risk factors for reduced theophylline clearance or if serum theophylline concentrations cannot be monitored
  • Adolescents ≥16 years and adults, including the elderly, with risk factors for reduced theophylline clearance, or when it is not feasible to monitor serum theophylline concentrations
    • The theophylline dose should not exceed 400 mg/day
    • Maximum: 400 mg/day
    • Applies in the presence of risk factors for reduced theophylline clearance or if serum theophylline concentrations cannot be monitored
  • Patients requiring a relatively high dose (equal to or greater than 900 mg or 13 mg/kg, whichever is less)
    • Should not take Theo-24 less than 1 hour before a high-fat-content meal
    • A high-fat meal may significantly increase peak serum level and extent of absorption compared to the fasted state
  • Twice-daily dosing with Theo-24 (when two doses per day are prescribed)
    • The second dose should be given 10 to 12 hours after the morning dose and before the evening meal
    • Once-a-day Theo-24 is taken each morning at approximately the same time and is not recommended at night
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Taking theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher C max and delayed T max and somewhat greater extent of absorption. However, the differences are usually not great and this product may normally be administered without regard to meals (see CLINICAL PHARMACOLOGY , Drug interactions , Drug-Food Interactions ). Theophylline extended-release tablets are recommended for chronic or long-term management and prevention of symptoms, and not for use in treating acute symptoms of asthma and reversible bronchospasm. General considerations: The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400- 1600 mg/day in adults <60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated , in small increments (see Table V).

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Theophylline side effects

▾

Most side effects are mild when theophylline blood levels stay within the recommended range, and often resemble caffeine-related effects:

Common side effects

  • Nausea and vomiting
  • Headache
  • Trouble sleeping (insomnia)
  • Restlessness or irritability
  • Tremors (shakiness)
  • Rapid heartbeat (sinus tachycardia)
  • Diarrhea or stomach upset
  • Dizziness
  • Stomach upset, diarrhea, or abdominal pain

When to get medical help

  • Seek emergency care if you have a seizure — this is a sign of dangerously high theophylline levels
  • Call your doctor right away if you have a fast or irregular heartbeat or palpitations
  • Get help immediately for persistent or severe vomiting that won't stop
  • Call your doctor if you notice confusion, disorientation, or unusual nervousness
  • Seek care for signs of a severe allergic reaction: rash, hives, or difficulty breathing
  • Call your doctor if side effects persist even when blood levels are in the normal range

If levels rise too high, serious reactions can occur — including persistent vomiting, dangerous heart rhythms (cardiac arrhythmias), and seizures. These are emergencies: seek immediate medical attention if any of these develop.

Theophylline warnings and precautions

▾
  • Narrow safety margin: The gap between an effective blood level and a toxic one is small. Levels must be monitored regularly — more often during illness or when other drugs are added or stopped.
  • Seizure risk: High theophylline levels can cause seizures that are difficult to treat and may cause permanent brain injury. Patients with existing seizure disorders face heightened risk.
  • Heart rhythm problems: Elevated levels can trigger serious cardiac arrhythmias, especially in patients with underlying heart disease.
  • Existing conditions: Theophylline must be used with extreme caution in people with active peptic ulcer disease, seizure disorders, or certain heart rhythm problems — it can worsen all of these.
  • Reduced clearance: Liver disease, heart failure, acute illness, and older age all slow how the body removes theophylline. Dose adjustments are essential in these situations.
  • Older adults (over 60): At greatest risk for severe toxicity and death from chronic overdosage.

Theophylline interactions

▾

Theophylline interacts with a wide range of drugs, foods, and health conditions. Adding or stopping any of these while on theophylline can push blood levels dangerously high or make the drug less effective:

  • Cimetidine (heartburn medication) — slows theophylline clearance, raising blood levels and toxicity risk
  • Erythromycin (antibiotic) — slows theophylline clearance, increasing levels
  • Rifampin (antibiotic) — speeds up clearance, potentially reducing theophylline's effectiveness
  • Many other prescription and over-the-counter drugs — can raise or lower levels significantly; always tell every provider and pharmacist you take theophylline
  • Low-carb / high-protein diets and charcoal-broiled foods — speed up clearance, potentially lowering effectiveness
  • High-carb / low-protein diets — slow clearance, potentially raising levels
  • Stopping an interacting drug — can cause theophylline to accumulate to toxic levels if the dose isn't adjusted promptly

Interactions listed in the FDA-approved label

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

  • Cimetidine, erythromycin (drugs that inhibit theophylline clearance): If theophylline is started in a patient already taking such a drug, the dose required to reach a therapeutic serum concentration will be smaller. Discontinuing such a drug will decrease serum theophylline concentrations unless the theophylline dose is appropriately increased.
  • Rifampin (drugs that enhance theophylline clearance): If theophylline is started in a patient already taking such a drug, the dose required to reach a therapeutic serum concentration will be larger. Discontinuing a drug that increases theophylline clearance will cause accumulation to potentially toxic levels unless the theophylline dose is appropriately reduced.
  • Drugs listed in Table II: They have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with theophylline. The Table II effects assume the interacting drug is added to a steady-state theophylline regimen.
  • Drugs listed in Table III: They have either been documented not to interact with theophylline or do not produce a clinically significant interaction.
Read the label’s full interactions text

Drug Interactions Drug-Drug Interactions : Theophylline interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to theophylline or another drug or occurrence of adverse effects without a change in serum theophylline concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of theophylline clearance is altered by another drug resulting in increased or decreased serum theophylline concentrations. Theophylline only rarely alters the pharmacokinetics of other drugs. The drugs listed in Table II have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with theophylline. The information in the “Effect” column of Table II assumes that the interacting drug is being added to a steady-state theophylline regimen. If theophylline is being initiated in a patient who is already taking a drug that inhibits theophylline clearance (e.g., cimetidine, erythromycin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be smaller. Conversely, if theophylline is being initiated in a patient who is already taking a drug that enhances theophylline clearance (e.g., rifampin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be larger. Discontinuation of a concomitant drug that increases theophylline clearance will result in accumulation of theophylline to potentially toxic levels, unless the theophylline dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits theophylline clearance will result in decreased serum theophylline concentrations, unless the theophylline dose is appropriately increased. The drugs listed in Table III have either been documented not to interact with theophylline or do not produce a clinically significant interaction (i.e., <15% change in theophylline clearance).

Excerpted — the section continues on the label. 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.

🌿126 supplements and herbs with documented Theophylline interactions, ranked by severity Check Theophylline against a supplement or herb →

Before taking Theophylline

▾
  • Allergy: Do not take theophylline if you have ever had an allergic reaction to it or any ingredient in the product.
  • Seizure disorders: Tell your doctor — theophylline must be used with extreme caution and close monitoring.
  • Active peptic ulcer disease: Theophylline can worsen this condition; discuss risks with your doctor.
  • Cardiac arrhythmias: Certain heart rhythm disorders increase the risk of serious complications with theophylline.
  • Liver disease: Significantly slows theophylline clearance — dose adjustment and frequent monitoring are required.
  • Heart failure or other serious illnesses: Reduce how quickly the body clears theophylline, raising toxicity risk.
  • Older adults (over 60): Face a higher risk of severe toxicity; require more frequent blood level checks.
  • Newborns and premature infants: Process theophylline very slowly; careful dosing and frequent monitoring are critical.
  • Pregnancy: Theophylline clearance changes at each trimester — inform your prescriber if you are pregnant or become pregnant.
  • Smokers and young patients: Often clear theophylline faster, which may affect dosing schedules.

Theophylline overdose

▾

Too much theophylline — whether from a single large dose or from taking slightly too much over time — can cause serious harm, including persistent vomiting, dangerous heart rhythms, and seizures that are hard to control and can be fatal. If you suspect a theophylline overdose, call poison control or go to an emergency room immediately. Older adults (over 60) and those with existing neurological or heart conditions face the greatest risk of life-threatening outcomes from overdosage.

What Theophylline does in the body

▾

Theophylline relaxes the smooth muscle around the airways (bronchodilation) and reduces the airways' sensitivity to triggers. It also increases the strength of the diaphragm contractions. Its effects are closely tied to blood concentration: meaningful symptom improvement generally requires levels above a certain threshold, while levels that climb too high significantly increase the risk and severity of adverse reactions — including heart rhythm problems and seizures.

How your body processes Theophylline

▾

Theophylline is rapidly and completely absorbed when taken by mouth as a solution or immediate-release form, and it distributes freely throughout the body's non-fat tissues. It is extensively broken down by the liver, and how quickly this happens varies enormously from person to person — age, smoking status, diet, and concurrent illnesses all play a role. Because individual variation is so wide and unpredictable, regular blood level monitoring is essential, especially during illness or when other medications are added or changed.

How to store Theophylline

▾

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Dispense in a tight, light-resistant container.

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

126

Supplements & herbs that interact with Theophylline

126 supplements and herbal products have documented interactions with Theophylline 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 · 89
  • Minor · 34
ACTIVATED CHARCOAL Major EPHEDRA Major SIDA CORDIFOLIA Major ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ASHITABA Moderate BACOPA Moderate BAIKAL SKULLCAP Moderate +118 more
Every supplement checked against Theophylline — ranked by severity The full interaction hub: 3 major · 89 moderate · 34 minor · every one linked to its full report. Check Theophylline 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

Theophylline 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.

POTASSIUM Moderate Depletion VITAMIN B6 Moderate Depletion
See the full Theophylline 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.

Theophylline: pharmacist answers to common questions

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

What exactly is theophylline supposed to do for me?

▾
Theophylline is a long-term controller medicine for chronic asthma, emphysema, and chronic bronchitis. It works by relaxing the muscles around your airways so they stay more open, and by calming your airways' tendency to overreact to things like dust or cold air. It's meant to be taken every day to keep symptoms under control — it's not a rescue inhaler for sudden attacks.

How should I take my theophylline, and does it matter when I take it?

▾
Yes, timing matters. If you're on Theo-24 extended-release capsules once a day, take it every morning at roughly the same time — taking it at night is not recommended because your body absorbs it differently overnight. If you're on twice-daily dosing, the second dose should come 10–12 hours after the morning dose and before the evening meal. For the oral solution, follow your prescriber's exact schedule. Always take it as directed and never skip a dose or double up without checking with your provider first.

What side effects should I expect, and which ones should I actually worry about?

▾
Early on, you might notice nausea, headache, trouble sleeping, or feeling restless — these are often described as caffeine-like effects, and they tend to improve as your body adjusts. Those are annoying but not dangerous at normal levels. What you do need to act on right away: persistent vomiting that won't stop, a racing or irregular heartbeat, shaking or tremors that get worse, seizures, or confusion. Those are signs your levels may be too high, and you need emergency care immediately.

Why do I need blood tests while taking this medication?

▾
Theophylline has a narrow safety window — the amount that works well and the amount that causes serious harm are not far apart. Blood tests check that your level stays in the safe zone. Many things can shift your levels without you realizing it: getting sick, starting a new medication, or even changing your diet significantly. Your provider will schedule these tests regularly, and more often if something in your health changes.

Are there any foods, drinks, or other medicines I should avoid?

▾
Quite a few things can affect theophylline levels. Eating a lot of charcoal-broiled meats or following a high-protein, low-carb diet can lower your theophylline levels. A high-carb, low-protein diet can raise them. Many common drugs — including certain antibiotics like erythromycin and rifampin, and heartburn medications like cimetidine — can push your levels too high or too low. Always tell every doctor, dentist, and pharmacist that you take theophylline before starting anything new.

Is there anything special I should know if I'm older, pregnant, or have other health conditions?

▾
Yes — and it's important. If you're over 60, your body clears theophylline more slowly, which means you're at higher risk for side effects and toxicity, so your levels will be checked more often. If you're pregnant, theophylline clearance changes with each trimester, so your dose may need to be adjusted. If you have liver disease, heart failure, or a seizure disorder, theophylline requires extra caution and close monitoring. Always keep your full medical history up to date with your prescriber.

Is Theophylline available over the counter?

▾
No. Theophylline is a prescription medicine: every Theophylline 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 Theophylline first available?

▾
The earliest FDA record we hold for Theophylline is from 1947: 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 Theophylline was first used.

Who makes Theophylline?

▾
26 companies currently list Theophylline products in the FDA's NDC Directory, including ENDO USA, Inc., Glenmark Pharmaceuticals Inc., USA, Ajanta Pharma USA Inc.. 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 Theophylline on HelloPharmacist

📊Theophylline supplement interactions126 checked — ranked by severity 🌿Drug & Supplement CheckerTheophylline vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Theophylline NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Theophylline 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.

Theophylline forms and strengths (how it comes)

Theophylline is available in 3 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 Theophylline inactive ingredients by manufacturer.

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Theophylline extended-release tablets are used to treat symptoms and reversible airflow obstruction associated with chronic asthma
  • Theophylline extended-release tablets are used for chronic lung diseases such as emphysema and chronic bronchitis
Important instructions
  • Theophylline extended-release tablets are taken by mouth and designed for steady, long-term symptom control
  • Follow your prescriber's dosing schedule and do not crush or chew extended-release tablets unless instructed
Available strengths 4 strengths
300 mg 400 mg 450 mg 600 mg
67 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Elixophyllin
How this form is used
What it may be used for
  • Elixophyllin oral solution is used to treat symptoms and reversible airflow obstruction in chronic asthma
  • Elixophyllin oral solution is used for chronic lung diseases including emphysema and chronic bronchitis
  • Theophylline oral solution is indicated for the same chronic asthma and chronic lung disease indications
Important instructions
  • Elixophyllin is a liquid taken by mouth; follow your prescriber's instructions for timing and frequency
  • Dose requirements can vary widely between patients — regular blood level monitoring is essential
  • Follow your prescriber's instructions exactly and do not adjust your dose without guidance
Available strengths 1 strength
80 mg/15 mL
17 FDA-listed product records ⓘ

Extended-release capsule

By mouth
Brands Theo-24
How this form is used
What it may be used for
  • Theo-24 is used to treat symptoms and reversible airflow obstruction in chronic asthma
  • Theo-24 is used for chronic lung diseases including emphysema and chronic bronchitis
  • Theo-24 is intended for patients with continuous or recurring symptoms needing steady theophylline levels — not for acute breathing attacks
Important instructions
  • Theo-24 is generally taken once each morning at approximately the same time every day
  • Theo-24 is not recommended as a once-daily product taken at night
  • Theo-24 may be taken twice daily for some patients; when two doses are prescribed, the second dose should be taken 10–12 hours after the morning dose and before the evening meal
  • Follow your prescriber's instructions exactly — do not exceed your prescribed dose
Available strengths 4 strengths
100 mg 200 mg 300 mg 400 mg
8 FDA-listed product records ⓘ

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

How Theophylline 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.

26 companies list 51 Theophylline product records with the FDA, mostly as extended-release tablet, oral solution, extended-release capsule; the earliest marketing or approval year on record is 1947. Brand names on the directory include Uniphyl, Theolair, Elixophyllin and 13 more; the rest are generics.

3
Dose forms ⓘ
26
Labelers (makers, repackagers, distributors)
3
Brand names
51
FDA-listed product records ⓘ
1947
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 (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

ENDO USA, Inc.8%
Glenmark Pharmaceuticals Inc., USA8%
Ajanta Pharma USA Inc.4%
Alembic Pharmaceuticals Inc.4%
Alembic Pharmaceuticals Limited4%
Amneal Pharmaceuticals NY LLC4%
Other makers69%

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

How widely Theophylline is used (Medicaid data)

A general measure of how commonly Theophylline 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 Theophylline 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.

16,886
Medicaid prescriptions filled (Q1–Q4 2025)
$1.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Theophylline prescribed? Of the 1,601 medications we measure, Theophylline ranks #830 by Medicaid prescriptions — more than 48% of them.

Where Theophylline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #830 of 1,601
#825 Oxymetazoline Nasal Sp... 17,358 Rx #826 Arformoterol Oral Inha... 17,345 Rx #827 Colesevelam 17,250 Rx #828 Itraconazole 17,092 Rx #829 Potassium Acetate 16,989 Rx #830 Theophylline 16,886 Rx #831 Raltegravir 16,834 Rx #832 Glyburide and Metformi... 16,761 Rx #833 Travoprost Ophthalmic 16,632 Rx #834 Bromocriptine 16,540 Rx #835 Ketoprofen 16,480 Rx

Utilization by Theophylline 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 300 mg extended release oral tablet is the most-dispensed Theophylline product — about 65% of these Medicaid prescriptions.

theophylline 300 MG Extended Release Oral Tablet Most dispensed

11,032 Medicaid prescriptions (Q1–Q4 2025) 65% of Theophylline prescriptions shown $716,708 gross reimbursement (before rebates) ≈ $65 per prescription (gross)

Summed across the 9 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 317769

theophylline 400 MG Extended Release Oral Tablet

2,775 Medicaid prescriptions (Q1–Q4 2025) 16% of Theophylline prescriptions shown $92,940 gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313291

theophylline 300 MG Extended Release Oral Capsule

784 Medicaid prescriptions (Q1–Q4 2025) 5% of Theophylline prescriptions shown $208,865 gross reimbursement (before rebates) ≈ $266 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313310

theophylline 200 MG Extended Release Oral Capsule

756 Medicaid prescriptions (Q1–Q4 2025) 4% of Theophylline prescriptions shown $184,991 gross reimbursement (before rebates) ≈ $245 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313272

theophylline 100 MG Extended Release Oral Capsule

603 Medicaid prescriptions (Q1–Q4 2025) 4% of Theophylline prescriptions shown $113,805 gross reimbursement (before rebates) ≈ $189 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 701712

theophylline 400 MG Extended Release Oral Capsule

470 Medicaid prescriptions (Q1–Q4 2025) 3% of Theophylline prescriptions shown $192,275 gross reimbursement (before rebates) ≈ $409 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198264

theophylline 5.33 MG/ML Oral Solution

298 Medicaid prescriptions (Q1–Q4 2025) 2% of Theophylline prescriptions shown $21,655 gross reimbursement (before rebates) ≈ $73 per prescription (gross)

Summed across the 2 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313306

theophylline 600 MG Extended Release Oral Tablet

168 Medicaid prescriptions (Q1–Q4 2025) <1% of Theophylline prescriptions shown $8,171 gross reimbursement (before rebates) ≈ $49 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 348472

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 Theophylline, 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 17 of 74 listed Theophylline NDCs with Medicaid activity.

Compare Theophylline products

A representative set of FDA-listed product records for Theophylline — 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 51 of 51 products — FDA National Drug Code Directory. See every product, package size and price: browse all 51 Theophylline NDCs →

Theophylline 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 2 Theophylline recalls since July 2021. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Aug 8, 2025 · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution c…
  • Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceutical… Lots: Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026 FDA record D-0583-2025 →
Ongoing Class II May 15, 2025 · Glenmark Pharmaceuticals Inc., USA
OOS results reported for the Dissolution (by UV) test.
  • Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: G… Lots: Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26 FDA record D-0452-2025 →

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) Theophylline RxCUI 10438 6 dose forms · 29 strengths
  1. Dose form (SCDF) Extended Release Oral Capsule RxCUI 374075 In current FDA listings
    Clinical drug / strength (SCD) 60 MG RxCUI 313312 100 MG RxCUI 701712 125 MG RxCUI 198257 200 MG RxCUI 313272 250 MG RxCUI 317869 300 MG RxCUI 313310 400 MG RxCUI 198264
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 374080 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 237178 175 MG RxCUI 199809 200 MG RxCUI 346574 250 MG RxCUI 314240 300 MG RxCUI 317769 400 MG RxCUI 313291 450 MG RxCUI 314241 600 MG RxCUI 348472
  3. Dose form (SCDF) Injection RxCUI 1860415 No current FDA listing
    Clinical drug / strength (SCD) 500 ML theophylline 0.8 MG/ML RxCUI 313263
  4. Dose form (SCDF) Oral Capsule RxCUI 374074 No current FDA listing
    Clinical drug / strength (SCD) 50 MG RxCUI 411090 100 MG RxCUI 198255 200 MG RxCUI 198259 300 MG RxCUI 198262
  5. Dose form (SCDF) Oral Solution RxCUI 374077 In current FDA listings
    Clinical drug / strength (SCD) 2 MG/ML RxCUI 108870 5.33 MG/ML RxCUI 313306 10 MG/ML RxCUI 425539
  6. Dose form (SCDF) Oral Tablet RxCUI 374073 No current FDA listing
    Clinical drug / strength (SCD) 100 MG RxCUI 198256 125 MG RxCUI 198258 200 MG RxCUI 198260 250 MG RxCUI 198261 300 MG RxCUI 198263 400 MG RxCUI 252482

Look up RxCUI 10438 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 Theophylline 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, Extended Release · Oral 300 mg $0.330 per tablet NDC details & price history
Tablet, Extended Release · Oral 450 mg $1.10 per tablet NDC details & price history
Capsule, Extended Release · Oral 400 mg $9.79 per capsule NDC details & price history
Capsule, Extended Release · Oral 200 mg $5.67 per capsule NDC details & price history
Capsule, Extended Release · Oral 100 mg $3.82 per capsule NDC details & price history
Capsule, Extended Release · Oral 300 mg $6.95 per capsule 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.

Theophylline brand names

Theophylline is sold under 16 brand names in the FDA directory — Uniphyl, Theolair, Elixophyllin, Theochron and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Uniphyl Theolair Elixophyllin Theochron Quibron-T Theo-24 Somophyllin Uni-dur Theovent Theophyl Theolixir Theoclear Theobid Theo-Dur T-Phyll Synophylate

Who makes Theophylline: manufacturers and labelers

26 companies list Theophylline products with the FDA. By number of product records, the largest are ENDO USA, Inc., Glenmark Pharmaceuticals Inc., USA, Ajanta Pharma USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

ENDO USA, Inc. 4 Glenmark Pharmaceuticals Inc., USA 4 Ajanta Pharma USA Inc. 2 Alembic Pharmaceuticals Inc. 2 Alembic Pharmaceuticals Limited 2 Amneal Pharmaceuticals NY LLC 2 Bryant Ranch Prepack 2 Camber Pharmaceuticals, Inc. 2 Chartwell RX, LLC 2 Golden State Medical Supply, Inc. 2 Harman Finochem Limited 2 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2 Leading Pharma, LLC 2 PAI Holdings, LLC dba PAI Pharma 2 PD-Rx Pharmaceuticals, Inc. 2 Proficient Rx LP 2 Strides Pharma Science Limited 2 Teva Pharmaceuticals, Inc. 2 Viona Pharmaceuticals Inc 2 Westminster Pharmaceuticals, LLC 2 Zydus Lifesciences Limited 2 Atlantic Biologicals Corp. 1 AvKARE 1 Bionpharma Inc., 1

…and 2 more on the FDA NDC directory.

Theophylline drug class (RxNorm)

Theophylline belongs to the Methylxanthine class.

Pharmacologic class Methylxanthine
Drug family (ATC) Xanthines

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 Theophylline 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 Oct 7, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Theophylline.
📈
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 Theophylline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
33
Finished products in the current FDA directory
51
Companies listing them (makers, repackagers, distributors)
26
FDA labeler codes behind them ⓘ
27
Linked representative label ⓘ
Leading Pharma, LLC
Linked label effective
Oct 7, 2024
Composite sections available
20
Linked SPL Set ID
ac490ebf-24e1-47c4-a932-ad4dcafe7aad
Linked SPL Document ID
a7dacdee-6f6b-4b85-b051-7779258a6971
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. Leading Pharma, LLC 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 →