FDA-filed SPL labeling · retrieved through openFDA

Aminophylline

Aminophylline is a bronchodilator (airway-opening) medicine used to treat acute flare-ups of asthma and other chronic lung diseases such as emphysema and chronic bronchitis.

Brand names Phyllocontin TabletsSomophyllin Oral SolutionTruphylline Suppositories
Drug classes ⓘ Methylxanthine
Rx Form 1 Route 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 9 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 effectiveJan 24, 2020
Clinical labels in scope ⓘ9
AvailabilityRx
Earliest approval/marketing year ⓘ1940
FDA-listed product records ⓘ28
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Aminophylline at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Aminophylline Injection is a hospital-based IV treatment that helps open airways during acute asthma attacks and flare-ups of chronic lung diseases like emphysema and chronic bronchitis. Because the safe and effective blood level range is narrow and varies widely between patients, your care team will monitor your theophylline levels closely throughout treatment. Always share your full medication list and medical history with your providers before starting this drug.

📖 Aminophylline: Patient Information Guide

A plain-language walkthrough of Aminophylline — 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▾

Aminophylline Injection is given intravenously to help manage acute respiratory crises. Here is what it is approved for:

  • Aminophylline Injection is indicated for acute exacerbations of asthma — used as an add-on to inhaled beta-2 agonist bronchodilators and systemic corticosteroids
  • Aminophylline Injection treats acute worsening of reversible airflow obstruction associated with emphysema
  • Aminophylline Injection treats acute flare-ups of chronic bronchitis
⚙️How it works▾

Aminophylline works by releasing theophylline in the body, which acts on the airways in two key ways. First, it relaxes the smooth muscle wrapped around the airways (bronchodilation), which widens them so air passes through more easily. Second, it dampens the airways' overreaction to irritants and triggers. Theophylline also strengthens the diaphragm — the main breathing muscle — helping it contract more forcefully. Blood levels must stay within a specific range: high enough to open airways but not so high that harmful effects kick in.

💊How it's taken▾

Aminophylline Injection is given only by IV in a healthcare setting — never self-administered. Treatment typically starts with a loading dose to quickly reach an effective blood level, then shifts to a continuous infusion to maintain it. Because the right dose varies dramatically between patients based on age, weight, other illnesses, and other medications, blood theophylline levels are checked frequently throughout treatment — sometimes as often as every few hours when first starting. Your care team will adjust the rate based on those levels. Do not adjust anything yourself.

🤒Side effects — in detail▾

Side effects are generally milder when theophylline blood levels stay in the recommended range, but become more frequent and severe as levels rise. Common side effects include:

  • Nausea and vomiting
  • Headache
  • Fast heartbeat (tachycardia)
  • Low blood pressure (hypotension)
  • Restlessness or irritability
  • Trouble sleeping
  • Tremor (shakiness)

At high theophylline levels, serious reactions — including seizures, life-threatening heart arrhythmias, and death — can occur. Tell your care team immediately if you feel your heart racing, feel confused, or experience severe nausea or vomiting.

⚠️Warnings & precautions▾
  • Narrow safety margin: The gap between a helpful and a toxic theophylline level is small. Levels must be monitored closely, especially in acutely ill patients.
  • Seizures: High theophylline levels can trigger seizures that are difficult to stop and can cause permanent brain injury or death if not treated rapidly.
  • Heart arrhythmias: Toxic levels can cause dangerous, potentially fatal abnormal heart rhythms.
  • Certain conditions increase risk: Active peptic ulcer disease, seizure disorders, and certain heart arrhythmias all require extra caution.
  • Slower clearance raises risk: Liver disease, heart failure, cor pulmonale, fever, hypothyroidism, and reduced kidney function in infants all slow the body's ability to clear theophylline — increasing the chance of toxicity at standard doses.
  • Age matters: Adults over 60 and newborns (including premature infants) are at significantly higher risk for serious toxicity.
🔀What it interacts with▾

Theophylline interacts with a wide range of drugs and some dietary factors. These interactions can raise theophylline to toxic levels or drop it below the effective range:

  • Cimetidine (acid-reducer) — slows theophylline clearance, raising blood levels
  • Erythromycin (antibiotic) — reduces theophylline clearance, raising blood levels
  • Rifampin (antibiotic) — speeds up theophylline clearance, potentially making it less effective
  • Stopping an interacting drug mid-treatment — can cause dangerous swings in theophylline levels in either direction
  • High-carbohydrate, low-protein diet — slows clearance, prolongs theophylline's stay in the body
  • Low-carbohydrate, high-protein diet or daily charcoal-broiled beef — speeds clearance, potentially reducing effectiveness
  • Many other drugs can interact — always give your full medication list to your care team

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▾
  • Do not use Aminophylline if you have had an allergic reaction to theophylline or ethylenediamine (a component of the product)
  • Tell your doctor if you have a seizure disorder — theophylline can make seizures harder to treat
  • Tell your doctor if you have a peptic ulcer — theophylline can worsen it
  • Tell your doctor if you have heart arrhythmias — theophylline can aggravate certain types
  • Tell your doctor about liver disease, heart failure, cor pulmonale, or thyroid problems — these reduce theophylline clearance and increase the risk of toxicity
  • Older adults (over 60) are at the greatest risk for serious toxicity and need closer monitoring
  • Newborns and premature infants clear theophylline very slowly and require especially careful dosing
  • Theophylline crosses the placenta and passes into breast milk — discuss the risks and benefits with your doctor if you are pregnant or breastfeeding
🚑If you take too much▾

Too much theophylline — whether from too high a dose or from a drug interaction that slows clearance — can be life-threatening. Signs of serious overdose include seizures, dangerous heart arrhythmias, and loss of consciousness; at very high blood levels, these can lead to death. If overdose is suspected, the infusion is stopped immediately, poison control is contacted, and supportive care is started right away — including seizure management, heart monitoring, and repeated blood-level checks until levels are clearly falling.

📡Pharmacodynamics — effects in the body▾

Theophylline relaxes the smooth muscle around the airways, widening them to reduce airflow resistance — this is called bronchodilation. It also blunts the airways' response to triggers that cause tightening and inflammation. Additionally, theophylline increases the strength of diaphragm muscle contractions, supporting more effective breathing. The beneficial effects on airflow occur within a specific blood concentration range; above that range, side effects become more frequent and severe.

🔬Pharmacokinetics — how your body processes it▾

Once given by IV, theophylline distributes throughout body water but not into fat — so doses are calculated on ideal body weight. About 40% binds to plasma proteins; the rest is the active, unbound drug. The liver metabolizes roughly 90% of the dose (in adults and children over one year), mainly through the CYP1A2 enzyme pathway. How quickly the body clears theophylline varies dramatically between patients and is heavily influenced by age, other illnesses (especially liver disease and heart failure), diet, and interacting drugs — which is why blood level monitoring is essential throughout treatment.

📦How to store it▾

Store at 20 to 25°C (68 to 77°F). PROTECT FROM LIGHT. Store in carton until time of use.

📄 Written from Aminophylline’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 →

22

Supplements & herbs that interact with Aminophylline

22 supplements and herbal products have documented interactions with Aminophylline 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 · 9
  • Minor · 10
Every supplement checked against Aminophylline — ranked by severity The full interaction hub: 3 major · 9 moderate · 10 minor · every one linked to its full report. Check Aminophylline 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.

1

Nutrient depletion considerations

Aminophylline has been associated with lower levels of 1 nutrient 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.

See the full Aminophylline 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.

🩺 Pharmacist Counseling Corner

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

Why am I getting aminophylline through an IV instead of just using my inhaler? ▾
Aminophylline injection is used when your breathing problem is serious enough to need hospital treatment. During a severe asthma attack or a bad flare of a chronic lung condition, your doctors use it as an extra tool alongside your inhaled medications and steroids to help open your airways faster. Think of it as a backup when inhalers alone aren't enough to get things under control quickly.
Why do the nurses keep checking my blood levels while I'm on this medication? ▾
Theophylline — the active drug aminophylline releases — has a narrow window between working well and causing serious problems. What's a safe dose for one person can be too much or too little for another, depending on your age, other health conditions, and other medications. Checking your blood levels frequently lets the team fine-tune your dose to keep you in the safe zone. This isn't unusual — it's just how this particular medicine has to be managed.
What side effects should I watch out for and tell the nurse about right away? ▾
Milder effects like headache, nausea, feeling jittery, or a faster heartbeat can happen and are worth mentioning to your care team. But you should tell them immediately — or call for help — if you feel your heart racing or beating irregularly in a way that concerns you, if you feel confused or unusually agitated, or if nausea becomes severe. Seizures are a rare but serious risk if levels get too high, so your team monitors carefully to prevent that.
I take other medications at home — does that matter? ▾
Yes, it really does. Aminophylline interacts with a surprisingly long list of drugs. Some — like the antibiotic erythromycin or the acid-reducer cimetidine — can cause theophylline to build up to potentially harmful levels. Others, like the antibiotic rifampin, can make the drug work less well. Make sure your care team has a complete list of everything you take, including over-the-counter drugs and supplements, so they can watch for any interactions.
I'm pregnant — is it safe for me to have this? ▾
Your doctors will weigh the risks and benefits carefully before using aminophylline during pregnancy. What the label tells us is that theophylline crosses the placenta and enters breast milk, so your baby is exposed to it. It's also worth knowing that theophylline clears more slowly in the third trimester, which changes how the dose needs to be managed. If you're pregnant or breastfeeding, make sure your care team knows so they can make the safest plan for you and your baby.
Are older adults at extra risk from this medicine? ▾
Yes — if you're over 60, the body tends to clear theophylline more slowly, which means it can build up to higher levels more easily. That raises the risk of serious side effects like seizures and heart rhythm problems, even at doses that would be fine for a younger person. This doesn't mean the medicine can't be used, but it does mean your care team will monitor your levels especially closely and be more conservative with dosing.
Is Aminophylline available over the counter? ▾
Aminophylline 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 Aminophylline first available? ▾
Aminophylline has been available in the United States since at least 1940, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Aminophylline? ▾
Aminophylline is supplied by 11 manufacturers listed in the FDA NDC Directory, including Henry Schein, Inc., Hospira, Inc., HF Acquisition Co LLC, DBA HealthFirst.

💬 Answers drafted from Aminophylline’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

💊 How Aminophylline comes

Aminophylline is available in 1 form. 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.

Injection

Into a vein
How this form is used
What it may be used for
  • Aminophylline Injection is used intravenously to treat acute worsening of asthma symptoms and reversible airflow obstruction
  • Aminophylline Injection is used alongside inhaled beta-2 agonists and corticosteroids — not alone
  • Aminophylline Injection is used for acute exacerbations of emphysema and chronic bronchitis
Important instructions
  • Aminophylline Injection is given only by a healthcare professional through an IV line in a clinical setting
  • Aminophylline Injection dosing begins with a loading dose when rapid effect is needed, followed by a continuous infusion — both adjusted to each patient
  • Aminophylline Injection requires regular blood level monitoring to keep theophylline in the safe therapeutic range
  • Aminophylline Injection dose must be based on ideal body weight for obese patients, as theophylline distributes poorly into body fat
Available strengths 1 strength
23 FDA-listed product records ⓘ

📊 Aminophylline across the U.S. market

How Aminophylline 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.

1
Dose forms ⓘ
11
Manufacturers
1
Brand names
28
FDA-listed product records ⓘ
1940
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Henry Schein, Inc.21%
Hospira, Inc.21%
HF Acquisition Co LLC, DBA HealthFirst14%
Medical Purchasing Solutions, LLC14%
Siegfried PharmaChemikalien Minden GmbH7%
General Injectables & Vaccines, Inc4%
Other makers18%

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

📈 How widely Aminophylline is used

A general measure of how commonly Aminophylline 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 Aminophylline 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.

9,002
Medicaid prescriptions filled (Q1–Q4 2025)
$272,857 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Aminophylline prescribed? Of the 1,597 medications we measure, Aminophylline ranks #945 by Medicaid prescriptions — more than 41% of them.

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

Utilization by Aminophylline 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 10 mL / 25 mg/mL injection is the most-dispensed Aminophylline product — about 64% of these Medicaid prescriptions.

10 ML aminophylline 25 MG/ML Injection Most dispensed

5,744 Medicaid prescriptions (Q1–Q4 2025) 64% of Aminophylline prescriptions shown $197,791 gross reimbursement (before rebates) ≈ $34 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 1724668

20 ML aminophylline 25 MG/ML Injection

3,258 Medicaid prescriptions (Q1–Q4 2025) 36% of Aminophylline prescriptions shown $75,066 gross reimbursement (before rebates) ≈ $23 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 1724666

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 Aminophylline, 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 2 of 15 listed Aminophylline NDCs with Medicaid activity.

🔍 Compare Aminophylline products

A representative set of FDA-listed product records for Aminophylline — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
25 mg/mL Intravenous General Injectables & Vaccines, Inc ANDA Find on DailyMed ↗
25 mg/mL Intravenous General Injectables & Vaccines, Inc. ANDA View NDC →
25 mg/mL Intravenous Henry Schein, Inc. × 6 listings ANDA View NDC →
25 mg/mL Intravenous HF Acquisition Co LLC, DBA HealthFirst × 4 listings ANDA View NDC →
25 mg/mL Intravenous Hospira, Inc. × 6 listings ANDA View NDC →
25 mg/mL Intravenous Medical Purchasing Solutions, LLC × 4 listings ANDA View NDC →
25 mg/mL Intravenous ProPharma Distribution ANDA View NDC →
💊Bulk drug substance
1 g/g — Qingdao Biopeptek Co., Ltd. BULK INGREDIENT View NDC →
1 g/g — Qingdao Qinzeyuan Biotechnology Co., Ltd BULK INGREDIENT View NDC →
1 kg/kg — Shandong Xinhua Pharmaceutical Company Limited BULK INGREDIENT View NDC →
1 kg/kg — Siegfried PharmaChemikalien Minden GmbH × 2 listings BULK INGREDIENT View NDC →

Showing 28 of 28 products — FDA National Drug Code Directory. See every product, package size and price: browse all 28 Aminophylline 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) Aminophylline RxCUI 689 6 dose forms · 7 strengths
  1. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 378388 No current FDA listing
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 378373 No current FDA listing
    Clinical drug / strength (SCD) 350 MG RxCUI 245318
  3. Dose form (SCDF) Oral Solution RxCUI 378316 No current FDA listing
  4. Dose form (SCDF) Oral Tablet RxCUI 378154 No current FDA listing
    Clinical drug / strength (SCD) 100 MG RxCUI 313794 200 MG RxCUI 308119
  5. Dose form (SCDF) Rectal Suppository RxCUI 378166 No current FDA listing
    Clinical drug / strength (SCD) 250 MG RxCUI 197354 500 MG RxCUI 308121

Look up RxCUI 689 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

Phyllocontin Tablets Somophyllin Oral Solution Truphylline Suppositories

🏭 Manufacturers & labelers

Henry Schein, Inc. 6 Hospira, Inc. 6 HF Acquisition Co LLC, DBA HealthFirst 4 Medical Purchasing Solutions, LLC 4 Siegfried PharmaChemikalien Minden GmbH 2 General Injectables & Vaccines, Inc 1 General Injectables & Vaccines, Inc. 1 ProPharma Distribution 1 Qingdao Biopeptek Co., Ltd. 1 Qingdao Qinzeyuan Biotechnology Co., Ltd 1 Shandong Xinhua Pharmaceutical Company Limited 1

RxNorm drug class

Aminophylline belongs to the Xanthines class.

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.

🔬 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 Jan 24, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Aminophylline.
📈
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 Aminophylline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
28
Distinct labelers/manufacturers represented
11
Linked representative label ⓘ
Medical Purchasing Solutions, LLC
Linked label effective
Jan 24, 2020
Composite sections available
17
Linked SPL Set ID
6936595d-255f-0321-e053-2a91aa0a15f7
Linked SPL Document ID
9ce56894-7463-c9d5-e053-2a95a90ae63e
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 9 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. Medical Purchasing Solutions, LLC 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.