Levomilnacipran
Levomilnacipran is an antidepressant (an SNRI) used to treat major depressive disorder in adults.
🧬 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 1 clinical label set 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 →
Levomilnacipran (Fetzima) is an SNRI antidepressant for major depressive disorder in adults that keeps more serotonin and norepinephrine, two mood chemicals, active in the brain; usually a later choice after better-known options, it has been around for over a decade and is available as a generic. Most people tolerate it reasonably well, though nausea, sweating, constipation and a faster heartbeat are common, and men may notice erection or ejaculation problems. Its boxed warning covers suicidal thoughts and behaviors in children, teens and young adults, so anyone taking it should be watched closely for worsening mood or new suicidal thoughts, especially in the first weeks and after dose changes.
Clinical pearls
- Skip alcohol entirely, because it can make the extended-release capsule release the medicine too fast.
- Swallow the capsule whole, never opened, chewed or crushed, and never stop it suddenly; the dose is tapered down instead.
- Get high blood pressure under control before starting, then have blood pressure and heart rate checked regularly.
- Ask before adding ibuprofen, naproxen or aspirin, since these NSAIDs plus levomilnacipran raise the risk of bleeding and bruising.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Antidepressants like Fetzima can increase suicidal thoughts and behaviors in children, teens and young adults. This was seen in short-term studies. Fetzima is not approved for anyone under 18.
Everyone taking an antidepressant should be watched closely for worsening depression or new suicidal thoughts or behavior. Report any of these to a doctor right away.
Patient information guide A plain-language walkthrough of Levomilnacipran, written from its FDA label.
What Levomilnacipran is used for
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Levomilnacipran is used for one condition.
- Major depressive disorder (MDD) in adults (Fetzima extended-release capsules).
- Fetzima is not approved for fibromyalgia.
How Levomilnacipran works
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Levomilnacipran blocks the reuptake of serotonin and norepinephrine in the brain. These are chemical messengers involved in mood. Blocking reuptake is thought to leave more of them available. The exact way it eases depression is unknown.
Levomilnacipran dosage
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Fetzima is an oral extended-release capsule taken once a day, with or without food. Take it around the same time daily and swallow it whole.
- Your prescriber usually starts low and raises the dose based on response and tolerability.
- Lower maximum doses apply with kidney problems or strong CYP3A4 inhibitors.
- Do not stop suddenly. Your dose is usually reduced gradually.
Dosing details from the FDA-approved label
From the Levomilnacipran 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.
- General recommended dosage (adults)
- 40 mg to 120 mg once daily with or without food
- Initiate at 20 mg once daily for 2 days and then increase to 40 mg once daily
- Based on clinical response and tolerability, may be increased in increments of 40 mg at intervals of 2 or more days
- Maximum: 120 mg once daily
- Swallow capsule whole; do not open, chew, or crush. Take at approximately the same time each day.
- Severe renal impairment (creatinine clearance of 15 to 29 mL/min)
- Dosage should not exceed 40 mg once daily
- Maximum: 40 mg once daily
- Renal impairment adjustment
- Moderate renal impairment (creatinine clearance of 30 to 59 mL/min)
- Dosage should not exceed 80 mg once daily
- Maximum: 80 mg once daily
- Renal impairment adjustment
- Mild renal impairment (creatinine clearance of 60 to 89 mL/min)
- No dosage adjustment recommended
- End stage renal disease (ESRD)
- Not recommended
- Use with strong CYP3A4 inhibitors
- Dose should not exceed 80 mg once daily when used with strong CYP3A4 inhibitors
- Maximum: 80 mg once daily
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended dosage: 40 mg to 120 mg once daily with or without food ( 2.1 ). Initial dosage is 20 mg once daily for 2 days and then increase to 40 mg once daily ( 2.1 ). Based on clinical response and tolerability, increase dose in increments of 40 mg at intervals of 2 or more days ( 2.1 ). The maximum recommended dosage is 120 mg once daily ( 2.1 ). Take capsules whole; do not open, chew or crush ( 2.1 ) Renal impairment ( 2.3 ) : ○ Severe renal impairment: Maximum recommended dosage is 40 mg once daily. ○ Moderate renal impairment: Maximum recommended dosage is 80 mg once daily. Discontinuation : Reduce dose gradually whenever possible ( 2.4 ) 2.1 Recommended Dosage The recommended dosage range for FETZIMA is 40 mg to 120 mg once daily, with or without food. FETZIMA should be initiated at 20 mg once daily for 2 days and then increased to 40 mg once daily. Based on clinical response and tolerability, FETZIMA may be increased in increments of 40 mg at intervals of 2 or more days. The maximum recommended dosage is 120 mg once daily. Take FETZIMA at approximately the same time each day. Swallow FETZIMA whole; do not open, chew, or crush the capsule. 2.2 Screen for Bipolar Disorder Prior to Starting FETZIMA Prior to initiating treatment with FETZIMA or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.8 ) ] . 2. 3 Dosage Recommendations for Patients with Renal Impairment End stage renal disease (ESRD): FETZIMA is not recommended; Severe renal impairment (creatinine clearance of 15 to 29 mL/min), the dosage should not exceed 40 mg once daily; Moderate renal impairment (creatinine clearance of 30 to 59 mL/min), the dosage should not exceed 80 mg once daily; Mild renal impairment (creatinine clearance of 60 to 89 mL/min): no dosage adjustment recommended [see Use in Specific Populations ( 8.7 )]. 2.4 Discontinuing Treatment with FETZIMA Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as FETZIMA. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing FETZIMA.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Levomilnacipran side effects
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The most common side effects in studies were:
Common side effects
- Nausea
- Constipation
- Vomiting
- Increased sweating
- Faster heart rate or palpitations (a pounding heartbeat)
- Erectile dysfunction
- Ejaculation problems
When to get medical help
- New or worsening depression, suicidal thoughts, or unusual changes in behavior. Call your doctor right away, especially in the first weeks and after dose changes.
- Signs of serotonin syndrome (a dangerous buildup of serotonin). Get medical help and tell your prescriber right away.
- Unusual bleeding or bruising, especially if you also take NSAIDs, aspirin or blood thinners.
- High blood pressure or a racing heartbeat.
- Trouble urinating or being unable to urinate.
- Seizures.
- Signs of mania or hypomania (unusually high energy or elevated mood).
- Eye pain or vision changes. Angle closure glaucoma has occurred with antidepressants in people with narrow angles.
Levomilnacipran warnings and precautions
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- Suicidal thoughts and behaviors (boxed warning), mainly in people 24 and younger.
- Serotonin syndrome, which can happen with other serotonergic drugs or even alone.
- Higher blood pressure and heart rate. Control high blood pressure before starting.
- Increased bleeding risk, especially with NSAIDs, aspirin or blood thinners.
- Angle closure glaucoma, urinary hesitation or retention, mania, seizures, and low sodium.
- Sexual dysfunction and discontinuation symptoms.
Levomilnacipran interactions
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Several drug types need special care with Fetzima.
- MAOIs, linezolid and IV methylene blue: contraindicated because of serotonin syndrome risk.
- Other serotonergic drugs (SNRIs, SSRIs, triptans, tricyclics, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort): raise serotonin syndrome risk.
- NSAIDs, aspirin, warfarin and other blood thinners: raise bleeding risk.
- Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin): raise drug levels, so the dose is capped.
- Alcohol: can speed release of the drug from the capsule, so avoid it.
Interactions listed in the FDA-approved label
From the Levomilnacipran prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue): Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. Contraindicated with an MAOI intended to treat psychiatric disorders or within 7 days of stopping FETZIMA; within 14 days of stopping an MAOI intended to treat psychiatric disorders; and in a patient being treated with linezolid or intravenous methylene blue.
- Other serotonergic drugs (e.g., other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, St. John's Wort): Concomitant use with other serotonergic drugs increases the risk of serotonin syndrome. Monitor for symptoms of serotonin syndrome. If it occurs, immediately discontinue FETZIMA and/or the concomitant serotonergic drugs.
- Drugs that interfere with hemostasis (antiplatelet or anticoagulant drugs, e.g., NSAIDs, aspirin, warfarin): Concomitant use may potentiate the risk of bleeding, possibly due to the effect of FETZIMA on the release of serotonin by platelets. Closely monitor for bleeding when FETZIMA is initiated or discontinued.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Concomitant use increases levomilnacipran exposure. The dose of FETZIMA should not exceed 80 mg once daily.
- Alcohol: Concomitant use may result in accelerated release of levomilnacipran. Avoid concomitant use of FETZIMA and alcohol.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong CYP3A4 inhibitors : Maximum recommended dosage is 80 mg once daily ( 7 ). 7.1 Drugs Having Clinically Important Interactions with FETZIMA Table 5 includes clinically important drug interactions with FETZIMA. Table 5: Clinically Important Drug Interactions with FETZIMA Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. Intervention: Concomitant use of FETZIMA is contraindicated: With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with FETZIMA. Within 14 days of stopping an MAOI intended to treat psychiatric disorders In a patient who is being treated with linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 , 2.6 ), Contraindications ( 4 ), and Warnings and Precautions ( 5.2 )] . Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact: Concomitant use of FETZIMA with other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor for symptoms of serotonin syndrome when FETZIMA is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, immediately discontinue FETZIMA and/or concomitant serotonergic drugs [ see Dosage and Administration ( 2.5 , 2.6 ) , Contraindications ( 4 ) , and Warnings and Precautions ( 5.2 ) ] . Examples: other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort Drugs that Interfere with Hemostasis Clinical Impact: Concomitant use of FETZIMA with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of FETZIMA on the release of serotonin by platelets.
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 Levomilnacipran
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- Do not take it if you are allergic to levomilnacipran, milnacipran or any ingredient.
- Tell your doctor about bipolar disorder, mania or hypomania in you or your family.
- Tell your doctor about high blood pressure, seizures, glaucoma or urinary problems.
- Kidney disease may require a lower maximum dose, and Fetzima is not recommended in end stage kidney disease. No dose change is advised for liver impairment.
- Pregnancy: late use may cause newborn complications and may raise postpartum bleeding risk.
- Breastfeeding: watch the infant for agitation, irritability, poor feeding and poor weight gain.
- Not approved for children.
- Older adults: low sodium may be more likely, and kidney function matters for dosing.
Levomilnacipran overdose
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Experience with overdose is limited. In studies, people took up to 360 mg in a day and none of the cases were fatal. There is no specific antidote, so care is supportive. Call Poison Control at 1-800-222-1222 or seek emergency help.
What Levomilnacipran does in the body
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Levomilnacipran binds strongly to the serotonin and norepinephrine transporters and blocks their reuptake. It has little effect on other receptors tested and does not inhibit MAO. At 2.5 times the maximum recommended dose, it did not lengthen the QTc (a heart rhythm measure) to any meaningful degree.
How your body processes Levomilnacipran
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Fetzima reaches peak levels about 6 to 8 hours after a dose. Food does not significantly change levels. The half-life is about 12 hours. It is broken down mainly by the CYP3A4 enzyme. It is cleared mostly by the kidneys, with about 58% leaving in urine as unchanged drug.
How to store Levomilnacipran
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All package configurations: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Levomilnacipran
156 supplements and herbal products have documented interactions with Levomilnacipran in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 110
- Minor · 42
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.
Levomilnacipran: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Levomilnacipran — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take it?
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What side effects are common?
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Can I drink alcohol with it?
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Can I stop it if I feel better?
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What should I watch for when starting?
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Is Levomilnacipran available over the counter?
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When was Levomilnacipran first available?
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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 Levomilnacipran on HelloPharmacist
Levomilnacipran forms and strengths (how it comes)
Levomilnacipran 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.
Extended-release capsule
How this form is used
- Fetzima is used to treat major depressive disorder in adults.
- Fetzima is not approved for fibromyalgia.
- Fetzima is taken once daily, with or without food.
- Swallow Fetzima capsules whole. Do not open, chew or crush them.
- Take Fetzima at about the same time each day.
- Avoid alcohol with Fetzima, since it can speed up release of the drug from the capsule.
Levomilnacipran on the U.S. market: products, makers and brands
How Levomilnacipran 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 company lists 6 Levomilnacipran product records with the FDA, mostly as extended-release capsule; the earliest marketing or approval year on record is 2008. Brand names on the directory include Fetzima; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) · Kit (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Levomilnacipran is used (Medicaid data)
A general measure of how commonly Levomilnacipran 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 Levomilnacipran 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 Levomilnacipran prescribed? Of the 1,601 medications we measure, Levomilnacipran ranks #813 by Medicaid prescriptions — more than 49% of them.
Utilization by Levomilnacipran 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.
24 HR levomilnacipran 120 MG Extended Release Oral Capsule Most dispensed
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433217
24 HR levomilnacipran 40 MG Extended Release Oral Capsule
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433233
24 HR levomilnacipran 80 MG Extended Release Oral Capsule
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433239
24 HR levomilnacipran 20 MG Extended Release Oral Capsule
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433227
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 Levomilnacipran, 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 4 of 19 listed Levomilnacipran NDCs with Medicaid activity.
Compare Levomilnacipran products
A representative set of FDA-listed product records for Levomilnacipran — 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 |
|---|---|---|---|---|
| 💊Extended-release capsule | ||||
| 20 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 40 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 80 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 120 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 💊Kits | ||||
| — | Oral | Allergan, Inc. × 2 listings | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Levomilnacipran NDCs →
Levomilnacipran 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 Levomilnacipran — 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 Levomilnacipran 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.
Levomilnacipran FDA approval history
How Levomilnacipran went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Levomilnacipran 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 Levomilnacipran recalls since July 2021.
✅No Levomilnacipran 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 1433212 1 dose form · 4 strengths
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Dose form (SCDF) Extended Release Oral Capsule RxCUI 1433216In current FDA listingsClinical drug / strength (SCD) 24 HR levomilnacipran 120 MGRxCUI 143321724 HR levomilnacipran 20 MGRxCUI 143322724 HR levomilnacipran 40 MGRxCUI 143323324 HR levomilnacipran 80 MGRxCUI 1433239
Look up RxCUI 1433212 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.
Levomilnacipran supply and shortage status
Whether Levomilnacipran 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 Levomilnacipran 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 | |
|---|---|---|---|
| Capsule, Extended Release · Oral | 120 mg | $17.59 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 20 mg | $17.60 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 40 mg | $17.61 per capsule | NDC details & price history |
| Capsule, Extended Release · Oral | 80 mg | $17.59 per capsule | 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.
Levomilnacipran brand names
Levomilnacipran is sold under one brand name in the FDA directory — Fetzima. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Levomilnacipran: manufacturers and labelers
One company lists Levomilnacipran products with the FDA. By number of product records, the largest are Allergan, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Levomilnacipran drug class (RxNorm)
Levomilnacipran belongs to the Serotonin and Norepinephrine Reuptake Inhibitor 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 Levomilnacipran 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. Allergan, 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 →