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Zongertinib

Zongertinib (Hernexeos) is a targeted kinase inhibitor used to treat adults with certain HER2-mutation-driven non-small cell lung cancer that cannot be surgically removed or has spread.

Brand name Hernexeos
Drug class Kinase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 22, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 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 →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026
Zongertinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Zongertinib (Hernexeos) is a once-daily targeted tablet for adults with advanced (cannot be removed surgically or has spread) non-squamous non-small cell lung cancer carrying a specific HER2 mutation, blocking overactive HER2 and its downstream growth signals; it is a specialist drug, new in 2025 under accelerated approval. Side effects are usually manageable, with diarrhea the one most people notice, plus rash or mouth sores. The key risk is liver injury, so expect regular blood tests and report yellow skin or eyes or dark urine right away. Heart function is checked too, and new breathlessness, cough or fever needs a prompt call, since serious lung inflammation can occur.

Clinical pearls

  • Swallow the tablets whole with water, with or without food, and never split, crush or chew them.
  • If a dose is more than 12 hours late, skip it, and if you vomit after a dose, do not repeat it.
  • Carbamazepine can make zongertinib less effective, and zongertinib can raise rosuvastatin levels, so flag both to every prescriber.
  • Women who can become pregnant need a pregnancy test first, then effective contraception and no breastfeeding until two weeks after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2025
Companies listing it with the FDA1
FDA label last updatedAug 13, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Zongertinib, written from its FDA label.

What Zongertinib is used for

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Zongertinib (brand name Hernexeos) is approved for one specific use in adults with lung cancer:

  • Hernexeos is used to treat adults with unresectable (inoperable) or metastatic (spread) non-squamous non-small cell lung cancer (NSCLC) whose tumors carry HER2 (ERBB2) tyrosine kinase domain activating mutations, confirmed by an FDA-authorized test.
  • This approval is based on objective response rate (how many tumors shrank) and duration of response (how long they stayed smaller). Continued approval may depend on results from ongoing confirmatory trials.

How Zongertinib works

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Zongertinib is a kinase inhibitor — it works by blocking HER2 (human epidermal growth factor receptor 2), a protein that, when mutated in certain lung cancers, sends abnormal signals telling cancer cells to grow and divide. By blocking HER2 and the downstream signals it triggers (like ERK phosphorylation), zongertinib slows or halts the growth of these cancer cells. Laboratory and animal studies confirmed it can reduce tumor activity in NSCLC models carrying these HER2 mutations.

Zongertinib dosage

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Hernexeos tablets are taken once daily by mouth, with or without food. The dose your prescriber recommends depends on your body weight. Tablets must be swallowed whole with water — never split, crushed, or chewed. Treatment continues until the cancer progresses or side effects become unacceptable.

  • Missed dose: If you remember within 12 hours of your usual time, take it. If more than 12 hours have passed, skip it and take your next dose as scheduled.
  • Vomited dose: Do not retake it — continue with your next dose at the regular time.

Dosing details from the FDA-approved label

From the Zongertinib 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.

  • Unresectable or metastatic NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations, patients weighing less than 90 kg
    • 120 mg orally once daily with or without food until disease progression or unacceptable toxicity
    • Swallow tablets whole with water; do not split, crush, or chew. If a dose is missed within 12 hours, take it; if missed by more than 12 hours, skip it. If vomited, do not take an additional dose. Dose reductions: 120 mg to 60 mg; permanently discontinue if unable to tolerate 60 mg once daily
  • Unresectable or metastatic NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations, patients weighing 90 kg or greater
    • 180 mg orally once daily with or without food until disease progression or unacceptable toxicity
    • Swallow tablets whole with water; do not split, crush, or chew. Dose reductions: 180 mg to 120 mg, then 60 mg; permanently discontinue if unable to tolerate 60 mg once daily
  • Patients weighing less than 90 kg when concomitant strong CYP3A inducer use cannot be avoided
    • Increase from 120 mg to 240 mg
    • Resume the prior dose 7 to 14 days after discontinuing the CYP3A inducer
  • Patients weighing 90 kg or greater when concomitant strong CYP3A inducer use cannot be avoided
    • Increase from 180 mg to 360 mg
    • Resume the prior dose 7 to 14 days after discontinuing the CYP3A inducer
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Select patients for treatment with HERNEXEOS based on the presence of HER2 (ERBB2) tyrosine kinase domain activating mutations. ( 2.1 ) The recommended dosage of HERNEXEOS is based on body weight: ( 2.2 ) Patients weighing less than 90 kg: 120 mg ( 2.2 ) Patients weighing 90 kg or greater: 180 mg ( 2.2 ) Take HERNEXEOS orally once daily with or without food until disease progression or unacceptable toxicity. ( 2.2 ) 2.1 Patient Selection Select patients for treatment of unresectable or metastatic NSCLC based on the presence of HER2 (ERBB2) tyrosine kinase domain activating mutations in tumor or plasma specimens [see Clinical Studies (14) ] . If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA-authorized tests for HER2 (ERBB2) tyrosine kinase domain activating mutations is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage and Administration The recommended dosage of HERNEXEOS is based on body weight: Patients weighing less than 90 kg: 120 mg Patients weighing 90 kg or greater: 180 mg Take HERNEXEOS orally once daily with or without food until disease progression or unacceptable toxicity. Swallow HERNEXEOS tablets whole with water. Do not split, crush, or chew tablets. Missed Dose If a dose is missed within 12 hours, take the dose. If a dose is missed by more than 12 hours, skip the missed dose and take the next scheduled dose. Vomited Dose If a dose is vomited, do not take an additional dose. Take the next dose at the regularly scheduled time. 2.3 Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are presented in Table 1. Table 1 Recommended HERNEXEOS Dose Reductions for Adverse Reactions Current HERNEXEOS Dose First Reduction Second Reduction 180 mg 120 mg 60 mg 120 mg 60 mg Permanently discontinue Permanently discontinue HERNEXEOS in patients who are unable to tolerate 60 mg once daily. The recommended dosage modifications for adverse reactions are presented in Table 2.

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

Zongertinib side effects

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Common side effects

  • Diarrhea
  • Skin rash
  • Fatigue or tiredness
  • Nausea
  • Musculoskeletal (muscle and joint) pain
  • Upper respiratory tract infections (such as colds)
  • Mouth sores (stomatitis)
  • Nail changes

When to get medical help

  • Call your doctor right away if you notice yellowing of the skin or eyes, dark urine, severe stomach pain, or unusual fatigue — these can be signs of liver problems (hepatotoxicity)
  • Tell your doctor immediately if you develop new or worsening shortness of breath, cough, or fever — these may signal a serious lung condition called interstitial lung disease or pneumonitis
  • Contact your doctor if you feel heart palpitations, unusual fatigue, or swelling in your legs — these could be signs of decreased heart function (left ventricular dysfunction)
  • Tell your prescriber if you are pregnant or plan to become pregnant — this drug can cause serious harm to an unborn baby

The most common side effects reported in clinical trials of Hernexeos include:

  • Diarrhea (very common — over half of patients)
  • Skin rash
  • Liver test abnormalities (hepatotoxicity)
  • Fatigue
  • Nausea
  • Muscle and joint pain (musculoskeletal pain)
  • Upper respiratory tract infections
  • Mouth sores (stomatitis)
  • Nail changes
  • Cough

More serious reactions — including severe liver injury, decreased heart pumping function, and life-threatening lung inflammation — require prompt medical attention. Tell your doctor right away if you develop yellowing of the skin or eyes, new shortness of breath, persistent cough, fever, or any signs of heart trouble.

Zongertinib warnings and precautions

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  • Liver toxicity (hepatotoxicity): Hernexeos can cause severe and life-threatening liver damage. Liver function tests are monitored at baseline, every 2 weeks for the first 12 weeks, then monthly. Watch for yellow skin or eyes, dark urine, or severe fatigue.
  • Decreased heart function (left ventricular dysfunction): Drops in the heart's pumping ability (LVEF) have occurred, including serious cases. Heart function is evaluated before starting and monitored regularly during treatment. Report shortness of breath, swelling, or palpitations.
  • Lung inflammation (interstitial lung disease/pneumonitis): Serious and potentially fatal lung inflammation has been reported. Seek care immediately for new or worsening shortness of breath, cough, or fever.
  • Fetal harm (embryo-fetal toxicity): Hernexeos can seriously harm an unborn baby. Effective contraception is required during treatment and for 2 weeks after the last dose. Do not breastfeed during treatment and for 2 weeks afterward.

Zongertinib interactions

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Zongertinib is broken down mainly by liver enzymes (CYP3A4/3A5), and it can affect how certain other drugs are processed. Key interactions to know about:

  • Strong CYP3A inducers (e.g., carbamazepine): These drugs significantly lower zongertinib blood levels, potentially making Hernexeos less effective. Avoid combining if possible; if unavoidable, the Hernexeos dose will need to be increased under medical supervision.
  • BCRP substrate drugs (e.g., rosuvastatin): Zongertinib raises blood levels of these drugs, which can increase their side effects. Some combinations should be avoided; others require close monitoring and possible dose adjustment of the other drug.
  • Strong CYP3A inhibitors, P-gp inhibitors, and proton pump inhibitors: No clinically significant effect on zongertinib levels was found with these drug classes in studies.

Interactions listed in the FDA-approved label

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

  • Strong CYP3A inducers: Zongertinib is a CYP3A substrate; strong CYP3A inducers decrease zongertinib exposure, which may reduce effectiveness of HERNEXEOS. Avoid concomitant use. If it cannot be avoided, increase the HERNEXEOS dose based on body weight.
  • BCRP substrates: Zongertinib is a BCRP inhibitor; HERNEXEOS increases exposure of BCRP substrates, which may increase the risk of adverse reactions related to these substrates. Avoid concomitant use with certain BCRP substrates where minimal concentration changes may lead to serious adverse reactions. If it cannot be avoided, monitor for increased adverse reactions and follow the substrate's approved labeling. For other BCRP substrates, monitor for increased adverse reactions and adjust dosages as clinically appropriate.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A Inducers : Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase HERNEXEOS dose. ( 7.1 ) BCRP Substrates : Avoid concomitant use with certain BCRP substrates where minimal concentration increase may lead to serious adverse reactions and consider alternative therapies. If concomitant use cannot be avoided, monitor patients closely for adverse reactions and follow recommendations provided in the BCRP substrate approved product labeling. For other BCRP substrates, monitor for increased adverse reactions and adjust the dosages of those substrates as clinically appropriate. ( 7.2 ) 7.1 Effects of Other Drugs on HERNEXEOS Avoid concomitant use of HERNEXEOS with strong CYP3A inducers. If concomitant use cannot be avoided, increase HERNEXEOS dose as recommended [see Dosage and Administration (2.4) ]. Zongertinib is a CYP3A substrate. Strong CYP3A inducers decrease zongertinib exposure [see Clinical Pharmacology (12.3) ] , which may reduce effectiveness of HERNEXEOS. 7.2 Effects of HERNEXEOS on Other Drugs BCRP Substrates Avoid concomitant use of HERNEXEOS with certain BCRP substrates where minimal concentration changes may lead to serious adverse reactions. If coadministration cannot be avoided, monitor for increased adverse reactions and follow recommendations provided in the approved product labeling for the BCRP substrate. For other BCRP substrates, monitor for increased adverse reactions and adjust the dosages of those substrates as clinically appropriate. Zongertinib is a BCRP inhibitor. HERNEXEOS increases exposure of BCRP substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.

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.

Check Zongertinib against a supplement or herb →

Before taking Zongertinib

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  • Pregnancy: Hernexeos can cause serious birth defects and harm to a developing baby. A pregnancy test is required before starting. Use effective contraception during treatment and for 2 weeks after the last dose.
  • Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose, due to the risk of serious harm to the infant.
  • Fertility: Animal studies suggest Hernexeos may affect fertility in both males and females. Talk to your doctor if this is a concern.
  • Heart disease history: Hernexeos has not been studied in patients with significant cardiac disease or reduced heart pumping function at baseline — inform your doctor of any heart history.
  • Liver or kidney problems: Mild liver impairment does not appear to meaningfully affect drug levels, but more severe liver or kidney impairment has not been fully studied. Tell your doctor about any organ function issues.
  • Children and adolescents: Safety and effectiveness have not been established in pediatric patients.
  • Older adults (65+): Approximately half of clinical trial participants were 65 or older; no major differences in safety or effectiveness were observed compared to younger patients.
  • All medications and supplements: Tell your prescriber about every drug, supplement, or herbal product you take, especially carbamazepine or cholesterol-lowering statins.

Zongertinib overdose

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In one reported case, a person who accidentally took 5 times the recommended daily dose experienced nausea and vomiting. If you think you or someone else has taken too much Hernexeos, contact a Poison Control Center or seek emergency medical attention right away.

What Zongertinib does in the body

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At concentrations well above the recommended therapeutic level (about 2.6 times the peak drug level from the standard dose), zongertinib did not cause a meaningful change in the QTc interval — the part of the heart's electrical cycle measured to assess irregular heart rhythm risk. The full relationship between zongertinib blood levels and its anti-cancer effects has not yet been completely mapped out.

How your body processes Zongertinib

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After taking Hernexeos by mouth, zongertinib reaches peak blood levels in about 2 hours and has an oral bioavailability of 76% — meaning most of the dose gets into circulation. It is extensively bound to blood proteins (over 99%) and has an effective half-life of about 12 hours, with steady blood levels reached within about 2.5 days of daily dosing. Food does not meaningfully affect how much drug is absorbed, so it can be taken with or without a meal.

Zongertinib is broken down mainly in the liver, primarily by CYP3A4/3A5 enzymes, and is eliminated mostly through the feces (about 93% of a dose), with very little excreted in urine. Age, sex, race, and mild kidney or liver impairment do not appear to significantly change how the body handles the drug.

How to store Zongertinib

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Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) . Store in the original container to protect from moisture.

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

Zongertinib: pharmacist answers to common questions

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

What exactly is Hernexeos being used to treat in my case?

▾
Hernexeos is a targeted cancer treatment specifically for adults with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that either can't be removed by surgery or has spread to other parts of the body. What makes it targeted is that it only works when your tumor has a specific HER2 gene mutation — your doctor confirmed this with a test before prescribing it. It works by blocking the HER2 protein that's driving your cancer cells to grow.

Can I take this pill with food, or does it need to be on an empty stomach?

▾
Good news — you can take Hernexeos with or without food, whichever is easiest for you. The important thing is to swallow the tablet whole with water. Don't split, crush, or chew it, as that can affect how the drug is released and absorbed. Try to take it at the same time each day to keep levels consistent.

What side effects are most likely, and which ones should make me call my doctor right away?

▾
The most common side effects are diarrhea (which affects more than half of patients), skin rash, fatigue, nausea, and muscle or joint pain. Most of these are manageable, and your care team can help with things like anti-diarrheal medication if needed. However, you should call your doctor right away if you notice yellowing of your skin or eyes, unusual tiredness or abdominal pain (possible liver problems), new or worsening shortness of breath or cough with fever (possible lung inflammation), or any signs of heart trouble like swelling in your legs or feeling your heart racing. These are rarer but serious and need prompt attention.

Are there any medications I should avoid while on Hernexeos?

▾
Yes, a couple of important ones. Carbamazepine — an anti-seizure and mood-stabilizing medication — and similar drugs that strongly activate liver enzymes can drop zongertinib levels in your blood enough to make Hernexeos less effective, so your doctor will want to avoid or adjust around those. Hernexeos can also raise blood levels of certain other drugs, particularly some cholesterol medications like rosuvastatin, increasing the risk of their side effects. Always tell every prescriber and your pharmacist that you're on Hernexeos so they can check for any conflicts.

Is it safe to get pregnant or breastfeed while taking this medication?

▾
Unfortunately, no — Hernexeos can cause serious harm to a developing baby, so it's really important to avoid pregnancy during treatment and for at least 2 weeks after your last dose. If you're a woman who could become pregnant, you'll need to use effective contraception the whole time you're on it, and your doctor will do a pregnancy test before you start. Breastfeeding is also not recommended during treatment and for 2 weeks after the last dose, because the potential risk to the baby is too high. If any of this affects your family planning, please have that conversation openly with your care team.

How will my doctor know if the drug is affecting my liver or heart?

▾
Your doctor will run blood tests to check your liver enzymes (ALT, AST, and bilirubin) before you start, then every 2 weeks for the first 3 months, and monthly after that. Your heart's pumping function (called LVEF) will also be checked with an imaging test before you start and at regular intervals during treatment. These aren't just routine checks — if there's a problem, your doctor can catch it early and adjust your dose or pause the medication before things get serious. That monitoring is an important part of staying safe on Hernexeos.

Is Zongertinib available over the counter?

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No. Zongertinib is a prescription medicine: every Zongertinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Zongertinib first available?

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The earliest FDA record we hold for Zongertinib is from 2025: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Zongertinib was first used.

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

More about Zongertinib on HelloPharmacist

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Detailed data & references for Zongertinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Zongertinib forms and strengths (how it comes)

Zongertinib 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.

Tablet

By mouth
Brands Hernexeos
How this form is used
What it may be used for
  • Hernexeos tablets are used to treat adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors test positive for HER2 (ERBB2) tyrosine kinase domain activating mutations
Important instructions
  • Hernexeos tablets are taken once daily by mouth, with or without food
  • Swallow Hernexeos tablets whole with water — do not split, crush, or chew them
  • If you miss a dose by 12 hours or less, take it; if more than 12 hours have passed, skip it and take the next dose at the regular time
  • If you vomit after taking Hernexeos, do not take an extra dose — resume your next scheduled dose as normal
Available strengths 2 strengths
60 mg 60 mg/601
3 FDA-listed product records ⓘ

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

How Zongertinib 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 1 Zongertinib product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2025. Brand names on the directory include Hernexeos; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2025
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Compare Zongertinib products

A representative set of FDA-listed product records for Zongertinib — 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
💊Tablet
60 mg Oral Boehringer Ingelheim Pharmaceuticals, Inc. NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Zongertinib NDCs →

Zongertinib 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 Zongertinib recalls since July 2021.

✅No Zongertinib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Zongertinib RxCUI 2721604 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 2721608 In current FDA listings
    Clinical drug / strength (SCD) 60 MG RxCUI 2721609

Look up RxCUI 2721604 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.

Zongertinib brand names

Zongertinib is sold under one brand name in the FDA directory — Hernexeos. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Hernexeos

Who makes Zongertinib: manufacturers and labelers

One company lists Zongertinib products with the FDA. By number of product records, the largest are Boehringer Ingelheim Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Boehringer Ingelheim Pharmaceuticals, Inc. 1

Zongertinib drug class (RxNorm)

Zongertinib belongs to the Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors class.

Drug family (ATC) Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors

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 Zongertinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 13, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Zongertinib.
📈
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 Zongertinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Boehringer Ingelheim Pharmaceuticals, Inc.
Linked label effective
Aug 13, 2026
Composite sections available
22
Linked SPL Set ID
d3fabf12-354e-4e5c-b5de-20fdb579b783
Linked SPL Document ID
0fd3e81b-38c9-4d19-b075-9256049a9d41
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Boehringer Ingelheim 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 →