FDA-filed SPL labeling · retrieved through openFDA

Tigecycline Injection

Tigecycline injection is a tetracycline-class antibiotic given intravenously to treat serious bacterial infections of the skin, abdomen, and lungs in adults.

Brand name Tygacil
Drug class ⓘ Tetracycline-class Antibacterial
Rx Form 1 Routes Intravenous · Intravenous, Parenteral · Intravenous; Parenteral
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 8 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 effectiveNov 18, 2025
Clinical labels in scope ⓘ8
AvailabilityRx
Earliest approval/marketing year ⓘ2005
FDA-listed product records ⓘ23
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Tigecycline Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tigecycline (Tygacil) is a powerful IV antibiotic reserved for serious skin, abdominal, and community-acquired pneumonia infections when other antibiotics are not appropriate. It carries a boxed warning for a small but real increase in all-cause mortality compared to other antibiotics, so it is used only when necessary. Nausea and vomiting are the most common side effects, and your care team will monitor your liver function and blood clotting proteins throughout treatment.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Important safety warning: Tigecycline has been associated with a higher risk of death compared to other antibiotics. A review of multiple clinical trials found that patients treated with tigecycline died at a slightly higher rate than those treated with alternative antibiotics — roughly 4 in 100 vs. 3 in 100 patients. The reason for this difference has not been fully determined, but deaths were generally related to worsening infections or serious underlying conditions. The risk was highest in patients with ventilator-associated pneumonia. Because of this, tigecycline should only be used when other antibiotic treatments are not an option. If you or your loved one is receiving this medication, your medical team has determined the benefits outweigh this risk in your specific situation.

Read the full warning on DailyMed →

📖 Tigecycline Injection: Patient Information Guide

A plain-language walkthrough of Tigecycline Injection — 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▾

Tigecycline injection (brand name Tygacil) is a broad-spectrum IV antibiotic approved for adults to treat specific serious bacterial infections. It is not a first-choice antibiotic for most situations — it is reserved for cases where other antibiotics aren't suitable.

  • Complicated skin and skin structure infections — serious bacterial infections of the skin and deeper tissues, including those caused by MRSA (methicillin-resistant Staphylococcus aureus)
  • Complicated intra-abdominal infections — serious infections inside the abdomen, such as those involving the intestines or abdominal lining, caused by a range of bacteria including resistant strains
  • Community-acquired bacterial pneumonia — bacterial pneumonia caught outside of a hospital setting, including cases where the infection has also entered the bloodstream (bacteremia)
  • Not approved for diabetic foot infections — a clinical trial failed to show it worked well enough for this use
  • Not approved for hospital-acquired pneumonia or ventilator-associated pneumonia — trials showed lower cure rates and higher mortality with tigecycline for these conditions
⚙️How it works▾

Tigecycline is a tetracycline-class antibiotic that works by shutting down bacterial protein production. It binds to the 30S ribosomal subunit — a key piece of the bacteria's protein-building machinery — and blocks amino acids from being added to growing protein chains. Without proteins, bacteria can't function or reproduce. For most bacteria, tigecycline stops their growth (bacteriostatic); but it can actually kill certain organisms like Streptococcus pneumoniae and Legionella pneumophila (bactericidal activity).

Tigecycline is designed to get around one of the most common forms of antibiotic resistance seen with older tetracyclines, which is why it remains active against some resistant bacteria, including MRSA and vancomycin-susceptible Enterococcus.

💊How it's taken▾

Tygacil is given only by intravenous (IV) infusion — it cannot be taken by mouth. It is infused slowly into a vein over about 30 to 60 minutes, typically once every 12 hours. Treatment generally lasts 5 to 14 days depending on the type and severity of infection; your prescriber will determine the right length of treatment for you.

  • Patients with severe liver impairment require a reduced maintenance dose — your doctor will adjust this
  • No dose adjustment is needed for kidney problems or for older adults based on age alone
  • Blood clotting tests (including fibrinogen levels) should be checked before starting and monitored regularly during treatment
🤒Side effects — in detail▾

The most common side effects of tigecycline are digestive — most people experience some degree of nausea or vomiting, especially in the first day or two of treatment.

  • Nausea (very common — affects about 1 in 4 patients)
  • Vomiting
  • Diarrhea
  • Abdominal (stomach) pain
  • Headache
  • Dizziness
  • Elevated liver enzymes on blood tests
  • Low blood protein (hypoproteinemia)

Seek medical attention right away if you develop severe diarrhea (especially with blood or mucus), signs of a serious allergic reaction (throat swelling, difficulty breathing, rapid heart rate), yellowing of the skin or eyes (jaundice), severe abdominal pain that could suggest pancreatitis, or any unusual bruising or bleeding.

⚠️Warnings & precautions▾
  • Increased all-cause mortality: Analysis of multiple clinical trials found that tigecycline-treated patients had a slightly higher death rate than those on comparator antibiotics (about 4% vs. 3%). The cause is not fully understood. This risk was greatest in patients with ventilator-associated pneumonia. Tigecycline should only be used when alternatives are not suitable.
  • Severe allergic reactions (anaphylaxis): Life-threatening allergic reactions have been reported. Patients with known allergy to tetracycline-class antibiotics should not receive tigecycline.
  • Liver damage: Significant liver problems, including liver failure, have occurred. Liver function should be monitored; tell your doctor immediately if you develop jaundice or extreme fatigue.
  • Pancreatitis: Acute pancreatitis, including fatal cases, has been reported — even in people without known risk factors. Severe stomach pain during treatment should prompt immediate evaluation.
  • Low fibrinogen (hypofibrinogenemia): Tigecycline can lower fibrinogen, a blood-clotting protein, increasing bleeding risk. Blood clotting tests must be monitored throughout treatment.
  • C. difficile diarrhea (CDAD): Like all antibiotics, tigecycline can disrupt normal gut bacteria and allow C. difficile to overgrow, causing severe or even life-threatening diarrhea — sometimes appearing weeks after finishing treatment.
  • Tooth and bone effects in children and pregnancy: Use during tooth development (second/third trimester of pregnancy, infancy, childhood under 8) can permanently discolor teeth and temporarily slow bone growth.
🔀What it interacts with▾

Tigecycline has a few important drug interactions your care team should know about before you start treatment.

  • Warfarin (blood thinner): Tigecycline may alter warfarin's effect on blood clotting. Blood clotting tests (prothrombin time) should be monitored closely during treatment.
  • Tacrolimus and cyclosporine (calcineurin inhibitors, used after organ transplant): Tigecycline may raise blood levels of these drugs, increasing the risk of serious toxicity. Blood levels of these medications must be checked regularly.
  • Oral contraceptives (birth control pills): Tigecycline, like other antibiotics, may reduce the effectiveness of hormonal birth control. Use an additional contraceptive method during treatment.

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▾
  • Allergy to tetracyclines: Do not use tigecycline if you are allergic to it or to any tetracycline antibiotic (such as doxycycline or minocycline) — serious allergic reactions, including anaphylaxis, have occurred.
  • Severe liver disease: Patients with severe liver impairment (Child-Pugh C) need a lower maintenance dose and close monitoring.
  • Pregnancy: Tigecycline may permanently stain developing baby teeth and may temporarily slow bone growth if used in the second or third trimester. Discuss the risks and benefits with your doctor if you are pregnant.
  • Breastfeeding: Tetracycline-class drugs pass into breast milk. Breastfeeding should be avoided during treatment and for 9 days after the last dose, especially if treatment lasts more than 3 weeks. Pumping and discarding breast milk during this period is an option to maintain milk supply.
  • Children under 18: Use is not recommended. The safety and effectiveness have not been established due to the increased mortality risk seen in adult trials. Use in children under 8 is especially discouraged due to the risk of permanent tooth discoloration.
  • Older adults: No dose adjustment is generally needed based on age alone, but older individuals may be more sensitive to some side effects — close monitoring is appropriate.
  • Intestinal perforation: Tigecycline should not be used alone (monotherapy) for abdominal infections caused by a hole or tear in the intestine — combination therapy is needed in those cases.
🚑If you take too much▾

There is limited information on tigecycline overdose. In a study where healthy volunteers received a high single dose, the main effects were increased nausea and vomiting. Tigecycline is not significantly removed by hemodialysis (kidney dialysis). If an overdose is suspected, contact your healthcare team or Poison Control immediately for guidance.

📡Pharmacodynamics — effects in the body▾

Tigecycline does not appear to significantly affect the heart's electrical rhythm — specifically, it did not meaningfully change the QTc interval (a measure of heart rhythm on an ECG) at doses studied in healthy volunteers, which is reassuring compared to some other antibiotics. Its primary measurable effect in the body is inhibiting bacterial growth by blocking protein synthesis at the ribosomal level.

🔬Pharmacokinetics — how your body processes it▾

After IV infusion, tigecycline distributes very widely throughout the body — it reaches tissues including the lungs, gallbladder, colon, and skin at concentrations often much higher than in the blood, which helps it fight infections in those locations. It is not heavily broken down by the liver; most of it is eliminated unchanged, primarily through bile and stool (about 59%), with the rest cleared through the urine.

Tigecycline has a long half-life (the time for the body to clear half the drug) of roughly 27 to 42 hours, which is why twice-daily dosing is sufficient. Patients with severe liver disease clear the drug more slowly and need a lower maintenance dose. Kidney disease does not significantly affect clearance, so no dose adjustment is needed for kidney problems.

📦How to store it▾

stored at 20° to 25°C (68° to 77°F). stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag) .

📄 Written from Tigecycline Injection’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 →

98

Supplements & herbs that interact with Tigecycline Injection

98 supplements and herbal products have documented interactions with Tigecycline Injection 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 · 2
  • Moderate · 88
  • Minor · 8
Every supplement checked against Tigecycline Injection — ranked by severity The full interaction hub: 2 major · 88 moderate · 8 minor · every one linked to its full report. Check Tigecycline Injection 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.

11

Nutrient depletion considerations

Tigecycline Injection has been associated with lower levels of 11 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 10
  • Moderate · 1
See the full Tigecycline Injection 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 Tigecycline Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting this antibiotic instead of a pill I can take at home? ▾
Tigecycline (Tygacil) is only available as an IV infusion — there's no pill form. It's used specifically for serious bacterial infections that need to be treated in a hospital setting, where your care team can monitor your response and manage any side effects. Your doctor chose it because it covers the type of bacteria causing your infection, especially if other antibiotics aren't a good fit for you.
I heard this antibiotic has a warning about death — should I be worried? ▾
It's completely understandable to be concerned, and I want to be honest with you about it. Clinical trial data did show that patients on tigecycline had a slightly higher death rate than those on other antibiotics — but we're talking about a difference of about 1 in 100 patients, in people who were already seriously ill. Your doctor has weighed this risk against the fact that other antibiotics aren't a good option for you right now. The benefits in your specific situation outweigh the risk, but it's always okay to ask your doctor why tigecycline was chosen for you.
What side effects should I expect, and what should I call my doctor about? ▾
Nausea and vomiting are by far the most common — they affect a lot of people, especially in the first day or two, but they're usually mild to moderate and tend to settle down. What you really want to watch for and report right away: severe diarrhea (especially watery, bloody, or persistent — this could be a serious gut infection called C. diff), severe stomach pain (which could signal pancreatitis), yellowing of your skin or eyes, signs of an allergic reaction like swelling or trouble breathing, or unusual bruising or bleeding. Don't tough it out with those — call your care team promptly.
Can I take my other medications while on this antibiotic? ▾
Most medications are fine alongside tigecycline, but there are a few important ones to flag. If you take warfarin (a blood thinner), your clotting levels will need extra monitoring during treatment. If you've had an organ transplant and take tacrolimus or cyclosporine, those drug levels need to be watched closely because tigecycline can raise them to potentially dangerous levels. And if you use birth control pills, there's a chance tigecycline could make them less effective — so using a backup method of contraception during treatment is a smart idea.
Is this safe if I'm pregnant or breastfeeding? ▾
This is an important question. Tigecycline belongs to the tetracycline family of antibiotics, and these drugs can permanently discolor a baby's developing teeth and temporarily slow bone growth if used in the second or third trimester of pregnancy. If you're breastfeeding, it's recommended to avoid nursing during treatment and for 9 days after the last dose — you can pump and discard milk during that time to keep up your supply. Your doctor will only use tigecycline in pregnancy or while breastfeeding if there's no safer alternative available.
How long will I be on this medication, and how will I know it's working? ▾
Treatment usually lasts anywhere from 5 to 14 days, depending on your type of infection and how well you're responding. For skin infections or abdominal infections, 5 to 14 days is typical; for pneumonia, it's usually 7 to 14 days. Your care team will be monitoring you closely — checking labs, watching your symptoms, and adjusting the plan as needed. Signs that it's working include reduced fever, less pain, and overall improvement in how you feel. Make sure to complete the full course even if you start feeling better sooner.
Is Tigecycline Injection available over the counter? ▾
Tigecycline Injection 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 Tigecycline Injection first available? ▾
Tigecycline Injection has been available in the United States since at least 2005, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tigecycline Injection? ▾
Tigecycline Injection is supplied by 11 manufacturers listed in the FDA NDC Directory, including Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., Amneal Pharmaceuticals LLC, Apotex Corp.

💬 Answers drafted from Tigecycline Injection’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 Tigecycline Injection comes

Tigecycline Injection 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

By injection · Into a vein · Parenteral
Brands Tygacil
How this form is used
What it may be used for
  • Tygacil is used to treat complicated skin and skin structure infections in adults 18 and older
  • Tygacil is used to treat complicated intra-abdominal infections in adults 18 and older
  • Tygacil is used to treat community-acquired bacterial pneumonia in adults 18 and older
  • Tygacil is not approved for diabetic foot infections or hospital-acquired/ventilator-associated pneumonia
Important instructions
  • Tygacil is given as an intravenous infusion over approximately 30 to 60 minutes, every 12 hours
  • Tygacil is prepared by reconstituting the powdered vial with an appropriate solution; the reconstituted solution should appear yellow to orange — discard if it is another color
  • Tygacil may be infused through a dedicated IV line or a Y-site; the line should be flushed before and after infusion if shared with other drugs
  • Tygacil should not be mixed in the same IV line at the same time as amphotericin B, diazepam, esomeprazole, or omeprazole
Available strengths 3 strengths
23 FDA-listed product records ⓘ

📊 Tigecycline Injection across the U.S. market

How Tigecycline Injection 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
2
Brand names
23
FDA-listed product records ⓘ
2005
First marketed ⓘ
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.22%
Amneal Pharmaceuticals LLC13%
Apotex Corp13%
Meitheal Pharmaceuticals Inc.13%
Sandoz Inc13%
Accord Healthcare Inc.4%
Other makers22%

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

📈 How widely Tigecycline Injection is used

A general measure of how commonly Tigecycline Injection 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 Tigecycline Injection 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.

794
Medicaid prescriptions filled (Q1–Q4 2025)
$245,130 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tigecycline Injection prescribed? Of the 1,597 medications we measure, Tigecycline Injection ranks #1,316 by Medicaid prescriptions — more than 18% of them.

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

Utilization by Tigecycline Injection 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.

tigecycline 50 MG Injection

794 Medicaid prescriptions (Q1–Q4 2025) 100% of Tigecycline Injection prescriptions shown $245,130 gross reimbursement (before rebates) ≈ $309 per prescription (gross)

Summed across the 5 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 581531

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 Tigecycline Injection, 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 5 of 21 listed Tigecycline Injection NDCs with Medicaid activity.

🔍 Compare Tigecycline Injection products

A representative set of FDA-listed product records for Tigecycline Injection — 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
50 mg/10 mL Intravenous Accord Healthcare Inc. NDA View NDC →
50 mg/5 mL Intravenous Amneal Pharmaceuticals LLC × 3 listings NDA View NDC →
50 mg/5 mL Intravenous Apotex Corp × 3 listings ANDA View NDC →
50 mg Intravenous AuroMedics Pharma LLC ANDA View NDC →
50 mg Intravenous Eugia US LLC ANDA View NDC →
50 mg/5 mL Intravenous Fresenius Kabi USA, LLC NDA View NDC →
50 mg/5 mL Intravenous Meitheal Pharmaceuticals Inc. × 3 listings ANDA View NDC →
50 mg — Patheon Italia S.p.A DRUG FOR FURTHER PROCESSING View NDC →
50 mg/10 mL Intravenous, Parenteral Sandoz Inc × 2 listings ANDA View NDC →
50 mg/10 mL Intravenous; Parenteral Sandoz Inc ANDA View NDC →
50 mg/5 mL Intravenous Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. × 5 listings NDA View NDC →
50 mg Intravenous Xellia Pharmaceuticals USA LLC ANDA View NDC →

Showing 23 of 23 products — FDA National Drug Code Directory. See every product, package size and price: browse all 23 Tigecycline Injection 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) Tigecycline Injection RxCUI 384455 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1724329 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 581531

Look up RxCUI 384455 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

Tygacil

🏭 Manufacturers & labelers

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 5 Amneal Pharmaceuticals LLC 3 Apotex Corp 3 Meitheal Pharmaceuticals Inc. 3 Sandoz Inc 3 Accord Healthcare Inc. 1 AuroMedics Pharma LLC 1 Eugia US LLC 1 Fresenius Kabi USA, LLC 1 Patheon Italia S.p.A 1 Xellia Pharmaceuticals USA LLC 1

RxNorm drug class

Tigecycline Injection belongs to the Tetracycline-class Antibacterial class.

Pharmacologic class Tetracycline-class Antibacterial
Drug family (ATC) Tetracyclines

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 Nov 18, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tigecycline Injection.
📈
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 Tigecycline Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
8
NDC products indexed
23
Distinct labelers/manufacturers represented
11
Linked representative label ⓘ
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Linked label effective
Nov 18, 2025
Composite sections available
23
Linked SPL Set ID
fd826e47-1b77-4ffd-bb22-fda3379903b0
Linked SPL Document ID
632c318a-2046-484c-9b5d-af354cbca86a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 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.

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. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 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.