What the label lists and what reports show
Nevirapine side effects
Nevirapine's FDA label: “The most common adverse reaction is rash.” FAERS holds 8,970 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug resistance (1,033 reports).
- Generic listed
- Boxed warning
Check it at the source: the nevirapine FDA label on DailyMed (effective July 15, 2026, Mylan Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of nevirapine tablets?Nevirapine tablets may cause serious side effects, including: See “ What is the most important information I should know about nevirapine tablets? ” • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicine. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine. • Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from your legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known. The most common side effect of nevirapine tablets is rash. […]
Source: FDA drug label, Mylan Pharmaceuticals Inc., effective July 15, 2026 (SPL set c6e93829-7024-48f6-8023-da6ff27dfc0a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction is rash.
Table 2 Percentage of Subjects with Moderate or Severe Drug-Related Events in Adult Placebo-Controlled Trials
| Reaction | Nevirapine (n = 1121) | Placebo (n = 1128) | Nevirapine (n = 253) | Placebo (n = 203) |
|---|---|---|---|---|
| Median exposure (weeks) | 58 | 52 | 28 | 28 |
| Any adverse event | 15% | 11% | 32% | 13% |
| Rash | 5 | 2 | 7 | 2 |
| Nausea | 1 | 1 | 9 | 4 |
| Granulocytopenia | 2 | 3 | < 1 | 0 |
| Headache | 1 | < 1 | 4 | 1 |
| Fatigue | < 1 | < 1 | 5 | 4 |
| Diarrhea | < 1 | 1 | 2 | 1 |
| Abdominal pain | < 1 | < 1 | 2 | 0 |
| Myalgia | < 1 | 0 | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reaction is rash. In adults, the incidence of rash is 15% versus 6% with placebo, with Grade 3/4 rash occurring in 2% of subjects. ( 6.1 ) • In pediatric subjects the incidence of rash (all causality) was 21%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trial Experience in Adult Patients The most serious adverse reactions associated with nevirapine are hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction [see Boxed Warning and Warnings and Precautions (5.1 , 5.2 )]. …
Source: FDA drug label, Mylan Pharmaceuticals Inc., effective July 15, 2026 (SPL set c6e93829-7024-48f6-8023-da6ff27dfc0a), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,970 reports list nevirapine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,523 are coded as a death and 1,649 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2017 (1,157, against a median of 318 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 17 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nevirapine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions