Viramune (Nevirapine) Official Info 2025: FDA Label, Dosage, Side Effects, Safety, and Access

You searched Viramune because you want the official facts now-what it is, where the real label lives, how to dose it safely, and which red flags matter most. I’ll get you to the right pages in under a minute, then give you the practical checks clinicians use every day. Heads-up: Viramune is the brand name for nevirapine, an older NNRTI used for HIV-1. It carries boxed warnings for severe liver injury and serious rash, so the first six weeks are all about vigilance.

What you’re likely trying to do right now

Most people who type “Viramune” want one or more of these:

• Grab the official, up-to-date drug label (FDA, EMA) or the exact patient leaflet.
• Confirm dosing (lead-in schedule, XR vs. immediate-release) and what to do after missed doses.
• Check major warnings (liver injury, rash/SJS/TEN) and the lab monitoring schedule.
• Scan drug interactions fast (rifampin, azoles, herbal products, hormonal contraception).
• See if the brand is still marketed, if generics exist, and what guidelines say in 2025.

If that matches your to-do list, keep going. I’ll point you straight to the authoritative sources, then give you the safety cheat sheets and clinician-style decision cues so you can act with confidence.

Go straight to the official sources (fast, precise steps)

Use these exact search phrases and on-page cues. You don’t need bookmarks.

1. FDA DailyMed (US labeling-most practical view):

   1. Search: “DailyMed nevirapine label”.
   2. Open the DailyMed result that lists nevirapine tablets, suspension, or XR.
   3. On the page, use the left sidebar to jump to “BOXED WARNING,” “DOSAGE AND ADMINISTRATION,” and “WARNINGS AND PRECAUTIONS.”
   4. Scroll to “DRUG INTERACTIONS” for the table; “PATIENT COUNSELING INFORMATION” for take-home points.

   Why this matters: DailyMed mirrors the current FDA-approved text and is easy to scan during care.

2. FDA Drugs@FDA (official label PDFs and approval history):

   1. Search: “Drugs@FDA nevirapine label”.
   2. Open the Drugs@FDA listing, then click “Label Information.”
   3. Pick the most recent “Prescribing Information” PDF for nevirapine (IR/XR as needed).

   Tip: Want historical changes (e.g., boxed warning language)? Use the “All labeling revisions” section.

3. EMA (Europe, SmPC):

   1. Search: “EMA nevirapine SmPC Viramune”.
   2. Open the EMA Product Information page for nevirapine/Viramune.
   3. Download the SmPC (health professional) and Package Leaflet (patient) PDFs.

   Note: EMA SmPC sections are numbered; 4.2 (posology) and 4.4 (special warnings) are your anchors.

4. US DHHS HIV Guidelines (2025):

   1. Search: “HIV.gov Adult and Adolescent ARV Guidelines 2025”.
   2. Open the guidelines landing page and use search/CTRL+F for “nevirapine” or “NNRTI”.
   3. Check sections on “What to Start,” “Adverse Effects,” and “Pregnancy” for current positioning (nevirapine is rarely first-line now).

   These are the US clinical standard for regimen selection and safety nuances.

5. WHO Consolidated Guidelines (global context):

   1. Search: “WHO consolidated guidelines HIV 2023 nevirapine”.
   2. Open the PDF and CTRL+F “nevirapine.”
   3. Review recommendations for legacy regimens, infant prophylaxis options, and resource-limited adjustments.

6. Brand vs. generic status (US/other markets):

   • In the US, brand Viramune has been largely supplanted by generic nevirapine; availability can vary by wholesaler and region.
   • Use the FDA “Orange Book” (search: “FDA Orange Book nevirapine”) to confirm generic approvals and dosage forms.
   • In other regions, check the national medicines regulator site or the EMA page above.

Primary sources to cite in documentation or risk discussions: FDA Prescribing Information (nevirapine), EMA SmPC for Viramune/nevirapine, US DHHS Antiretroviral Guidelines (2025), WHO consolidated HIV guidelines (latest update).

Fast facts you can trust: dosing, forms, boxed warnings, interactions

Use this as your quick reference. Always confirm patient-specific dosing in the label and guidelines.

Evidence anchors: FDA Prescribing Information (nevirapine) and EMA SmPC list the boxed warnings and the lead-in schedule; DHHS (2025) explains why nevirapine is rarely first-line now and outlines pregnancy-era decisions.

Safe-use checklists and decision cues clinicians actually follow

Use these as your guardrails. Modify with your local guidelines.

Before starting or restarting

• Confirm indication: Part of a combination antiretroviral regimen-never monotherapy.
• Baseline labs: AST/ALT, bilirubin, CBC, pregnancy test if relevant, hepatitis B/C status, HIV RNA, CD4 count.
• Risk screen: CD4 count (women >250; men >400 = higher liver risk), prior nevirapine rash or hepatitis, current rash, active hepatitis.
• Interaction sweep: Check for rifampin, carbamazepine, phenytoin, phenobarbital, azoles (ketoconazole, itraconazole), macrolides (clarithromycin), warfarin, DOACs, tacrolimus/cyclosporine, methadone, hormonal contraceptives, and herbal products (St. John’s wort).
• Lead-in plan: 200 mg once daily x 14 days (IR only) before any dose increase or XR switch.

During the first 6 weeks (highest-risk window)

• Do not escalate dose early if there is any rash. Hold at lead-in or stop based on severity per label.
• Stop immediately and seek care if there’s fever, mucosal lesions, blistering, facial swelling, persistent sore throat, dark urine, jaundice, severe fatigue, or right upper quadrant pain.
• LFTs: Recheck often in the first 6 weeks; keep a low threshold to pause therapy if enzymes rise with symptoms.

XR vs. IR-simple rules

• Never start with XR. Always complete the 14-day IR lead-in first.
• After lead-in, switch to 400 mg XR once daily if tolerated and appropriate.
• If you stop for more than 7 days, restart the IR lead-in before returning to full dose or XR.

Contraception and pregnancy

• Nevirapine can reduce estrogen/progestin levels. Use nonhormonal or backup contraception.
• If already suppressed on nevirapine and pregnant, check the 2025 DHHS pregnancy section; continuing may be reasonable if no toxicity and alternatives are complicated. Starting nevirapine during pregnancy is generally not preferred.

When to avoid or stop

• History of nevirapine-associated hepatitis or severe rash (including SJS/TEN): do not rechallenge.
• Active, significant hepatic disease: avoid initiation.
• Early systemic symptoms with rash or LFT rise: stop and evaluate-don’t wait it out.

FAQ and next steps (patients, clinicians, pharmacists)

Quick answers to the most common follow-ups I hear-and what to do next.

Is Viramune still sold, or is it all generic now?

In many places the brand has been phased out and replaced by generic nevirapine. In the US, generics are widely available; supply depends on wholesalers. Check your pharmacy system and the FDA Orange Book for approved forms. Outside the US, check the EMA or your national authority.

Why is there a 14-day lead-in?

The lower once-daily start reduces the chance of early rash and liver injury. If the patient tolerates 14 days without significant issues, the dose increases to the regular maintenance schedule. This rule is straight from the FDA label and EMA SmPC.

Can I use ER (XR) from day one?

No. Use immediate-release 200 mg once daily for the first 14 days. If tolerated, transition to 400 mg XR once daily. If therapy is interrupted for more than a week, restart the IR lead-in.

How common are serious reactions?

Rash is fairly common (often mild). Serious skin reactions like SJS/TEN are rare but can be life-threatening. Severe liver events are uncommon overall but the risk is higher during the first 6 weeks and in women with CD4 >250 or men >400 at initiation. These patterns are highlighted in FDA/EMA warnings.

Top interactions I shouldn’t miss?

Rifampin (reduces nevirapine exposure; avoid), St. John’s wort (avoid), certain azoles and macrolides (can raise levels), enzyme-inducing anticonvulsants (can reduce nevirapine or co-meds), and hormonal contraceptives (reduced efficacy). Always run a full interaction check using a trusted database along with the label tables.

What labs before and after starting?

Baseline AST/ALT, bilirubin, CBC, pregnancy test if relevant, HIV RNA, CD4, and HBV/HCV status. Re-check liver enzymes frequently during the first 6 weeks and periodically up to 18 weeks, or more often if symptoms appear.

Can I crush the tablets?

IR tablets can be split or crushed if needed; XR tablets should not be crushed or chewed. If swallowing is an issue, the oral suspension is an option. Confirm with the label and a pharmacist for your specific product.

What if a patient already has liver disease?

Nevirapine increases the risk of hepatotoxicity. Avoid initiation in moderate-to-severe hepatic impairment. If started in carefully selected cases, monitor closely and stop at early signs of hepatitis.

Pregnancy and breastfeeding?

For starting therapy, integrase-based regimens are preferred in 2025. If the patient is already stable on nevirapine, experts may continue with careful monitoring. Breastfeeding advice varies by region; where breastfeeding is supported with ART, maternal viral suppression and infant prophylaxis protocols guide decisions. Use DHHS or WHO sections for the latest specifics.

Can I switch off nevirapine to a modern regimen?

Often yes, especially to an integrase-based regimen, if no resistance barriers. Check the patient’s resistance history (if available) and use DHHS “Regimen Switching” guidance.

Access problems-brand backorder or generic out?

Ask your pharmacy to check wholesalers for generic nevirapine. If prolonged outage, the care team can consider a switch to a guideline-preferred regimen. Do not stop antiretrovirals without a plan.

Where do I cite this from?

Use: FDA Prescribing Information (nevirapine), EMA SmPC, US DHHS Antiretroviral Guidelines (2025), WHO consolidated HIV guidelines (latest). These are the gold-standard primary sources.

Next steps by role

• Patient/caregiver: If starting soon, write down symptoms to watch (fever, rash with blisters, jaundice, dark urine, severe fatigue). Keep your first 6-week lab schedule. If you miss more than 7 days, call your clinic before restarting.
• Clinician: Document CD4 at initiation, counsel on early toxicity, schedule early LFTs (e.g., at 2 and 4-6 weeks), and set clear stop rules. Avoid co-use with rifampin. Consider switch to integrase-based therapy if appropriate.
• Pharmacist: Run a full interaction check, flag contraceptive interactions, confirm the lead-in plan, and verify that XR isn’t used during the first 14 days.
• Program/low-resource settings: Align with WHO guidance; if nevirapine remains in local protocols (e.g., infant prophylaxis pathways), ensure dosing charts are current and staff know rash/hepatitis red flags.

If you only remember three things: lead-in is non-negotiable; the first 6 weeks are the danger zone; and any rash with systemic symptoms or liver warning signs means stop and re-evaluate. For the exact wording you’ll cite, open the FDA/EMA label using the steps above.