Formoterol Oral Inhalation
Formoterol oral inhalation is a long-acting bronchodilator, given by nebulizer, used twice a day for ongoing treatment of airway narrowing in chronic obstructive pulmonary disease (COPD).
🧬 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 15 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 →
Formoterol nebulizer solution is a long-acting bronchodilator, relaxing the muscles around the airways to keep them open, used twice daily as maintenance treatment for COPD (including chronic bronchitis and emphysema); on the market since about 2001 and available as a generic, it is a standard choice for people who do better with a nebulizer than a handheld inhaler. It is usually well tolerated, and dry mouth, nausea or trouble sleeping are the side effects people tend to notice most. It is not a rescue medicine and not for asthma, so keep a short-acting rescue inhaler on hand and call your prescriber promptly if you need it more often or your breathing worsens.
Clinical pearls
- Do not combine it with salmeterol or any other long-acting airway opener (a LABA), since doubling up can cause serious heart effects.
- Keep each vial sealed in its foil pouch until the moment you use it, and never mix it with other nebulizer medicines.
- Beta-blockers can cancel its benefit and may trigger severe airway tightening, so every prescriber should know you use formoterol.
- Theophylline, steroids and water pills can push potassium lower alongside formoterol, which is worth watching on routine blood work.
Patient information guide A plain-language walkthrough of Formoterol Oral Inhalation, written from its FDA label.
What Formoterol Oral Inhalation is used for
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Formoterol oral inhalation (as the nebulizer solution) is used for:
- Long-term, twice-daily maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema.
It is not for sudden COPD worsening or for asthma.
How Formoterol Oral Inhalation works
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Formoterol is a long-acting beta 2 -agonist that acts locally in the lungs. It attaches to beta 2 -receptors in airway muscle and raises cyclic AMP, which relaxes the muscle and opens the airways. It is far more selective for beta 2 -receptors than beta 1 -receptors, but the heart also has some beta 2 -receptors, so heart effects can still occur.
Formoterol Oral Inhalation dosage
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The nebulizer solution is breathed in by mouth, twice a day (morning and evening), using a standard jet nebulizer with an air compressor.
- Keep vials in the foil pouch until right before use.
- Discard any leftover liquid.
- Don't mix it with other medicines in the nebulizer.
- Don't go above the prescribed amount.
Follow your prescriber's directions and the label. Ask your pharmacist what to do about a missed dose.
Dosing details from the FDA-approved label
From the Formoterol Oral Inhalation 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.
- COPD maintenance treatment (formoterol fumarate inhalation solution)
- One 20 mcg unit-dose vial (20 mcg/2 mL) administered twice daily (morning and evening) by nebulization
- Every 12 hours
- For oral inhalation only, via a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor
- Maximum: A total daily dose greater than 40 mcg is not recommended
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dose of formoterol fumarate inhalation solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended. Formoterol fumarate inhalation solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of formoterol fumarate inhalation solution have been established in clinical trials when administered using the PARI-LC Plus ® nebulizer (with a facemask or mouthpiece) and the PRONEB ® Ultra compressor. The safety and efficacy of formoterol fumarate inhalation solution delivered from non-compressor based nebulizer systems have not been established. Formoterol fumarate inhalation solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded. If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered. The drug compatibility (physical and chemical), efficacy, and safety of formoterol fumarate inhalation solution when mixed with other drugs in a nebulizer have not been established. For oral inhalation only. • One 20 mcg/2 mL vial every 12 hours ( 2 ) • For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor ( 2 )
Read the full Dosage and Administration section on DailyMed →
Formoterol Oral Inhalation side effects
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The most common side effects in studies were:
Common side effects
- Diarrhea
- Nausea
- Stuffy or runny nose and sore throat (nasopharyngitis)
- Dry mouth
- Vomiting
- Dizziness
- Trouble sleeping (insomnia)
When to get medical help
- Get emergency help if your breathing suddenly gets worse right after a dose (paradoxical bronchospasm, a life-threatening airway tightening). Stop the medicine.
- Get emergency help for signs of a severe allergic reaction: hives, rash, swelling of the face, lips, tongue or throat, or trouble breathing.
- Call your doctor promptly if your usual dose stops working, your symptoms get worse, or you need your rescue inhaler more often than usual.
- Call your doctor if you have a fast or pounding heartbeat, chest pain, or a big rise in blood pressure.
- Seek help right away if you may have used too much. Overdose can cause serious heart problems and can be fatal.
Get urgent help for sudden worsening breathing, signs of a serious allergic reaction, chest pain, or a racing or irregular heartbeat.
Formoterol Oral Inhalation warnings and precautions
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- Not for asthma: long-acting beta-agonists used without an inhaled corticosteroid raise the risk of serious asthma-related events, including death.
- Not a rescue medicine: don't start it during an acute COPD worsening, and use a short-acting inhaler for sudden symptoms.
- Don't overuse: too much, or combining with other long-acting beta-agonists, can cause serious heart effects and may be fatal.
- Paradoxical bronchospasm: can be life-threatening. Stop the medicine and get help.
- It can affect heart rate and blood pressure, lower potassium and raise blood sugar.
- Severe allergic reactions can occur.
Formoterol Oral Inhalation interactions
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Several medicines can change how formoterol affects your heart, potassium or breathing:
- Other long-acting beta-agonists: risk of overdose.
- Other adrenergic drugs: stimulant effects may be stronger.
- Xanthines, steroids, diuretics: may lower potassium more.
- Loop or thiazide diuretics: ECG changes or low potassium may worsen.
- MAO inhibitors, tricyclic antidepressants, QTc-prolonging drugs: heart effects may increase.
- Beta-blockers: can reduce formoterol's effect and cause severe bronchospasm in COPD.
Interactions listed in the FDA-approved label
From the Formoterol Oral Inhalation prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Other adrenergic drugs: The sympathetic effects of formoterol may be potentiated if additional adrenergic drugs are given by any route. Use with caution.
- Xanthine derivatives, steroids, or diuretics: May potentiate any hypokalemic effect of adrenergic agonists. Use with caution.
- Non-potassium sparing diuretics (such as loop or thiazide diuretics): ECG changes and/or hypokalemia can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Caution is advised in co-administration; the clinical significance of these effects is not known.
- MAO inhibitors, tricyclic antidepressants, and drugs known to prolong the QTc interval: The effect of adrenergic agonists on the cardiovascular system may be potentiated; drugs that prolong the QTc interval have an increased risk of ventricular arrhythmias. Administer with extreme caution.
- Beta-blockers: Beta-blockers and formoterol may inhibit the effect of each other; beta-blockers may block the therapeutic effects of beta-agonists and may produce severe bronchospasm in COPD patients. Patients with COPD should not normally be treated with beta-blockers; if there is no acceptable alternative, cardioselective beta-blockers could be considered, with caution, and only when medically necessary.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3 , 7.1 ) • Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 5.7 , 7.2 , 7.3 ) • MAO inhibitors, tricyclic antidepressants and drugs that prolong QTc interval may potentiate effect on the cardiovascular system. Use with extreme caution. ( 7.4 ) • Beta-blockers may decrease effectiveness. Use with caution and only when medically necessary. ( 7.5 ) 7.1 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see WARNINGS AND PRECAUTIONS ( 5.3 , 5.5 , 5.6 , 5.7 ) ]. 7.2 Xanthine Derivatives, Steroids, or Diuretics Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists [see WARNINGS AND PRECAUTIONS ( 5.7 )]. 7.3 Non-potassium Sparing Diuretics The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. 7.4 MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs Formoterol, as with other beta 2 -agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
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.
Before taking Formoterol Oral Inhalation
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- Not for asthma. Using it without an inhaled corticosteroid is contraindicated in asthma.
- Tell your doctor about heart disease, high blood pressure, irregular heartbeat, seizures, an overactive thyroid or diabetes.
- Not for use in children.
- Pregnancy: human data are limited, and use in labor should be restricted to cases where benefits clearly outweigh risks.
- Breastfeeding: unknown whether it passes into human milk, so discuss with your doctor.
- Older adults: similar safety and effectiveness were seen, but some may be more sensitive.
Formoterol Oral Inhalation overdose
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Too much formoterol can cause chest pain, a very fast or irregular heartbeat (up to about 200 beats per minute), high or low blood pressure, tremor, seizures, muscle cramps, low potassium and high blood sugar. Cardiac arrest and death are possible. Treatment means stopping the medicine, supportive care and heart monitoring. Call poison control at 1-800-222-1222.
What Formoterol Oral Inhalation does in the body
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Most of formoterol's unwanted effects come from excess activation of beta receptors in the rest of the body. These can include tremor, muscle cramps, insomnia, a faster heartbeat, lower potassium and higher blood sugar. In a 12-week trial at the usual dose, heart rate and rhythm did not differ meaningfully from placebo. Much higher exposures raised pulse rate and lengthened the QT interval.
How your body processes Formoterol Oral Inhalation
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At usual doses, formoterol levels in the blood are very low. After a much higher dose, levels peaked in about 12 minutes. Much of an inhaled dose is probably swallowed and absorbed through the gut. Formoterol is broken down mainly by the liver through glucuronidation and O-demethylation. About 1.1% to 1.7% of a dose is excreted unchanged in urine, and the average terminal half-life was about 7 hours.
How to store Formoterol Oral Inhalation
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Prior to dispensing to the patient : Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Formoterol Oral Inhalation
103 supplements and herbal products have documented interactions with Formoterol Oral Inhalation in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 84
- Minor · 19
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.
Formoterol Oral Inhalation: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Formoterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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Can I use it when I'm suddenly short of breath?
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How do I use it?
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What side effects should I expect?
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Do I need to tell you about my other medicines?
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Is it safe in pregnancy?
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Is Formoterol Oral Inhalation available over the counter?
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When was Formoterol Oral Inhalation first available?
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Who makes Formoterol Oral Inhalation?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Formoterol Oral Inhalation on HelloPharmacist
Formoterol Oral Inhalation forms and strengths (how it comes)
Formoterol Oral Inhalation 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.
Inhalation solution (nebulizer)
How this form is used
- Formoterol fumarate inhalation solution is used for long-term, twice-daily maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema.
- Formoterol fumarate inhalation solution is not for sudden COPD worsening or for asthma.
- Formoterol fumarate inhalation solution is taken by oral inhalation twice daily, morning and evening, using a standard jet nebulizer connected to an air compressor.
- Formoterol fumarate inhalation solution should stay in its foil pouch until just before use. Discard any partly used vial.
- Formoterol fumarate inhalation solution has not been shown to be safe or effective with non-compressor nebulizer systems, and should not be mixed with other drugs in the nebulizer.
Formoterol Oral Inhalation on the U.S. market: products, makers and brands
How Formoterol Oral Inhalation 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.
13 companies list 14 Formoterol Oral Inhalation product records with the FDA, mostly as inhalation solution (nebulizer); the earliest marketing or approval year on record is 2001. Brand names on the directory include Perforomist, Foradil; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Formoterol Oral Inhalation is used (Medicaid data)
A general measure of how commonly Formoterol Oral Inhalation 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 Formoterol Oral Inhalation 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.
How commonly is Formoterol Oral Inhalation prescribed? Of the 1,601 medications we measure, Formoterol Oral Inhalation ranks #869 by Medicaid prescriptions — more than 46% of them.
Utilization by Formoterol Oral Inhalation 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.
formoterol fumarate 0.01 MG/ML Inhalation Solution
Summed across the 19 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1246319
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 Formoterol Oral Inhalation, 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 19 of 51 listed Formoterol Oral Inhalation NDCs with Medicaid activity.
Compare Formoterol Oral Inhalation products
A representative set of FDA-listed product records for Formoterol Oral Inhalation — 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 |
|---|---|---|---|---|
| 💊Inhalation solution (nebulizer) | ||||
| 20 mcg/2 mL | Respiratory (inhalation) | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Devatis, Inc. | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 0.02 mg/2 mL | Respiratory (inhalation) | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Lifestar Pharma LLC | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Micro Labs Limited | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | NorthStar RxLLC | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Ritedose Pharmaceuticals, LLC | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 20 mcg/2 mL | Respiratory (inhalation) | Viatris Specialty LLC | NDA | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Formoterol Oral Inhalation NDCs →
Formoterol Oral Inhalation 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 Formoterol Oral Inhalation — a signal of what to watch for, not proof the drug caused it.
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 Formoterol Oral Inhalation 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.
Formoterol Oral Inhalation FDA approval history
How Formoterol Oral Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Formoterol Oral Inhalation 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 Formoterol recalls since July 2021.
✅No Formoterol recalls on record since July 2021Source: 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.
RxCUI 25255 2 dose forms · 2 strengths
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Dose form (SCDF) Inhalation Powder RxCUI 2108402No current FDA listingClinical drug / strength (SCD) fumarate 0.012 MGRxCUI 1246326 -
Dose form (SCDF) Inhalation Solution RxCUI 2108395In current FDA listingsClinical drug / strength (SCD) fumarate 0.01 MG/MLRxCUI 1246319
Look up RxCUI 25255 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.
Formoterol Oral Inhalation supply and shortage status
Whether Formoterol Oral Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Formoterol Oral Inhalation 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.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Solution · Respiratory (inhalation) | 20 mcg/2 mL | $1.27–$1.34 per mL | NDC details & price history |
| Solution · Respiratory (inhalation) | 0.02 mg/2 mL | $1.27–$1.34 per mL | NDC details & 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.
Formoterol Oral Inhalation brand names
Formoterol Oral Inhalation is sold under 2 brand names in the FDA directory — Perforomist, Foradil. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Formoterol Oral Inhalation: manufacturers and labelers
13 companies list Formoterol Oral Inhalation products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Alembic Pharmaceuticals Inc., Devatis, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Formoterol Oral Inhalation drug class (RxNorm)
Formoterol Oral Inhalation belongs to the beta2-Adrenergic Agonist class.
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 Formoterol Oral Inhalation 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.
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. Mylan 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 →