Drug · FAERS side-effect profile with label screen
Nelfinavir side effects: what 2,090 FDA adverse event reports show
Drug class
Protease inhibitor
FDA label, Indications wording of the closest related product
Label matched
Nelfinavir Mesylate (Viracept)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,090 reports · 92% serious · 110 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. ( 1 )
FDA label, Indications and Usage
What it is
VIRACEPT ® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease. VIRACEPT Tablets are available for oral administration as a light-blue, capsule-sh.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 2Reporting / coding artifact 4Lab value / disease marker 5Not in label — unassessed 29
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 69 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug exposure during pregnancy | 413 | 121.6 111.5–132.7ROR 151.4 · χ² 48,771 / p <1e-300 | 119.5 EB05 110.1 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious PRR 81.4 | no trial data cached |
| Anhedonia | 210 | 80.2 70.5–91.2ROR 89.1 · χ² 16,238 / p <1e-300 | 79.0 EB05 70.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 49.8 · 100% consumer | no trial data cached |
| Caesarean section | 88 | 75.7 61.6–92.9ROR 78.9 · χ² 6,364 / p <1e-300 | 73.9 EB05 61.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 47.2 · ♀ 74% (drug 42%) | no trial data cached |
| Osteopenia | 91 | 60.2 49.2–73.7ROR 62.9 · χ² 5,213 / p <1e-300 | 59.2 EB05 49.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 | no trial data cached |
| Economic problem | 89 | 58.3 47.5–71.5ROR 60.8 · χ² 4,929 / p <1e-300 | 57.3 EB05 48.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 37.8 · 96% consumer | no trial data cached |
| Pregnancy | 96 | 47.9 39.3–58.2ROR 50.1 · χ² 4,341 / p <1e-300 | 47.2 EB05 39.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 · ♀ 89% (drug 42%) | no trial data cached |
| Eyelid ptosis | 46 | 45.6 34.2–60.7ROR 46.6 · χ² 1,954 / p <1e-300 | 44.6 EB05 34.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 42%) | no trial data cached |
| Premature baby | 115 | 38.4 32.1–45.9ROR 40.6 · χ² 4,139 / p <1e-300 | 38.0 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 | no trial data cached |
| Bone density decreased | 115 | 36.6 30.6–43.7ROR 38.6 · χ² 3,935 / p <1e-300 | 36.2 EB05 31.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 26.0 · 100% consumer | no trial data cached |
| Osteoporosis | 137 | 33.5 28.5–39.4ROR 35.8 · χ² 4,281 / p <1e-300 | 33.3 EB05 28.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Blood lactate dehydrogenase increased | 40 | 25.2 18.6–34.3ROR 25.7 · χ² 905 / p 3e-199 | 24.9 EB05 19.1 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 16.8 | no trial data cached |
| Foetal exposure during pregnancy | 203 | 25.1 22.1–28.7ROR 27.7 · χ² 4,688 / p <1e-300 | 25.0 EB05 22.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.1 | no trial data cached |
| Multiple fractures | 41 | 24.9 18.4–33.7ROR 25.4 · χ² 915 / p 3e-201 | 24.6 EB05 18.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Splenomegaly | 27 | 23.2 15.9–33.8ROR 23.5 · χ² 551 / p 5e-122 | 22.8 EB05 16.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 19% (drug 42%) | no trial data cached |
| Platelet count increased | 29 | 22.3 15.5–32.1ROR 22.6 · χ² 569 / p 5e-126 | 22.0 EB05 16.0 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 18.4 | no trial data cached |
| Bone loss | 33 | 21.9 15.6–30.7ROR 22.2 · χ² 635 / p 2e-140 | 21.6 EB05 16.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 19% (drug 42%) | no trial data cached |
| Decreased activity | 23 | 21.6 14.4–32.4ROR 21.8 · χ² 431 / p 6e-96 | 21.2 EB05 14.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 19.4 | no trial data cached |
| Osteonecrosis (bone death) | 67 | 20.3 16.1–25.7ROR 21.0 · χ² 1,211 / p 1e-265 | 20.2 EB05 16.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 17% (drug 42%) | no trial data cached |
| Emotional distress | 236 | 19.5 17.3–22.0ROR 21.9 · χ² 4,147 / p <1e-300 | 19.5 EB05 17.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · 97% consumer | no trial data cached |
| Abortion induced | 18 | 19.2 12.1–30.4ROR 19.4 · χ² 292 / p 8e-66 | 18.7 EB05 12.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Chronic kidney disease | 140 | 18.4 15.6–21.6ROR 19.6 · χ² 2,286 / p <1e-300 | 18.3 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.6 · 84% consumer | no trial data cached |
| Nephropathy | 17 | 18.2 11.3–29.3ROR 18.4 · χ² 259 / p 1e-58 | 17.6 EB05 11.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Hyperlipidaemia | 21 | 17.6 11.5–27.0ROR 17.8 · χ² 312 / p 3e-70 | 17.2 EB05 11.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 10% (drug 42%) | no trial data cached |
| Hepatomegaly | 17 | 17.3 10.8–27.8ROR 17.4 · χ² 245 / p 2e-55 | 16.7 EB05 10.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Diplopia (double vision) | 41 | 15.9 11.7–21.5ROR 16.2 · χ² 556 / p 3e-123 | 15.7 EB05 11.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 0% (drug 42%) | no trial data cached |
| End stage renal disease | 28 | 15.3 10.6–22.1ROR 15.5 · χ² 359 / p 2e-80 | 14.9 EB05 10.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Quality of life decreased | 20 | 15.0 9.7–23.2ROR 15.1 · χ² 247 / p 7e-56 | 14.4 EB05 9.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Abortion spontaneous | 58 | 14.5 11.2–18.7ROR 14.9 · χ² 715 / p 7e-158 | 14.3 EB05 11.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 100% (drug 42%) · 91% clinician | no trial data cached |
| Hypotonia | 14 | 14.0 8.3–23.7ROR 14.1 · χ² 157 / p 3e-36 | 12.9 EB05 7.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Tooth loss | 28 | 13.5 9.3–19.5ROR 13.6 · χ² 311 / p 7e-70 | 13.0 EB05 9.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Vitamin d deficiency | 13 | 13.4 7.8–23.1ROR 13.5 · χ² 137 / p 6e-32 | 12.1 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Drug resistance | 33 | 12.9 9.2–18.1ROR 13.1 · χ² 351 / p 1e-78 | 12.5 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · ♀ 19% (drug 42%) | no trial data cached |
| Skeletal injury | 13 | 12.5 7.3–21.5ROR 12.6 · χ² 126 / p 2e-29 | 11.0 EB05 6.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Blood triglycerides increased | 22 | 12.5 8.2–18.9ROR 12.6 · χ² 221 / p 3e-50 | 11.7 EB05 7.8 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 12.3 | no trial data cached |
| Hepatic encephalopathy | 10 | 10.8 5.8–20.0ROR 10.8 · χ² 79 / p 3e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Hyperbilirubinaemia | 11 | 10.7 5.9–19.3ROR 10.8 · χ² 87 / p 4e-21 | 8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Proteinuria | 20 | 10.7 6.9–16.5ROR 10.8 · χ² 165 / p 4e-38 | 9.6 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Ventricular extrasystoles | 11 | 10.6 5.9–19.2ROR 10.7 · χ² 86 / p 7e-21 | 8.7 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Foot fracture | 20 | 10.6 6.8–16.3ROR 10.7 · χ² 164 / p 8e-38 | 9.6 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Gamma-glutamyltransferase increased | 23 | 10.4 6.9–15.6ROR 10.5 · χ² 187 / p 9e-43 | 9.5 EB05 6.4 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug exposure during pregnancy | 413 | 121.6 111.5–132.7ROR 151.4 · χ² 48,771 / p <1e-300 | 119.5 EB05 110.1 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious PRR 81.4 | no trial data cached |
| Anxiety | 236 | 8.3 7.4–9.4ROR 9.2 · χ² 1,530 / p <1e-300 | 8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 93% consumer | no trial data cached |
| Emotional distress | 236 | 19.5 17.3–22.0ROR 21.9 · χ² 4,147 / p <1e-300 | 19.5 EB05 17.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · 97% consumer | no trial data cached |
| Anhedonia | 210 | 80.2 70.5–91.2ROR 89.1 · χ² 16,238 / p <1e-300 | 79.0 EB05 70.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 49.8 · 100% consumer | no trial data cached |
| Foetal exposure during pregnancy | 203 | 25.1 22.1–28.7ROR 27.7 · χ² 4,688 / p <1e-300 | 25.0 EB05 22.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.1 | no trial data cached |
| Chronic kidney disease | 140 | 18.4 15.6–21.6ROR 19.6 · χ² 2,286 / p <1e-300 | 18.3 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.6 · 84% consumer | no trial data cached |
| Osteoporosis | 137 | 33.5 28.5–39.4ROR 35.8 · χ² 4,281 / p <1e-300 | 33.3 EB05 28.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Anaemia (low red blood cells) | 120 | 6.3 5.3–7.5ROR 6.6 · χ² 536 / p 7e-119 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Bone density decreased | 115 | 36.6 30.6–43.7ROR 38.6 · χ² 3,935 / p <1e-300 | 36.2 EB05 31.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 26.0 · 100% consumer | no trial data cached |
| Premature baby | 115 | 38.4 32.1–45.9ROR 40.6 · χ² 4,139 / p <1e-300 | 38.0 EB05 32.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 | no trial data cached |
| Depression | 110 | 4.8 4.0–5.8ROR 5.0 · χ² 334 / p 6e-75 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 76% consumer | no trial data cached |
| Renal failure (kidney failure) | 100 | 7.5 6.2–9.1ROR 7.8 · χ² 561 / p 3e-124 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Pregnancy | 96 | 47.9 39.3–58.2ROR 50.1 · χ² 4,341 / p <1e-300 | 47.2 EB05 39.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 · ♀ 89% (drug 42%) | no trial data cached |
| Osteopenia | 91 | 60.2 49.2–73.7ROR 62.9 · χ² 5,213 / p <1e-300 | 59.2 EB05 49.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 | no trial data cached |
| Economic problem | 89 | 58.3 47.5–71.5ROR 60.8 · χ² 4,929 / p <1e-300 | 57.3 EB05 48.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 37.8 · 96% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anhedonia — n=210, PRR 80.2
- Caesarean section — n=88, PRR 75.7
- Osteopenia — n=91, PRR 60.2
- Pregnancy — n=96, PRR 47.9
- Eyelid ptosis — n=46, PRR 45.6
- Premature baby — n=115, PRR 38.4
- Osteoporosis — n=137, PRR 33.5
- Multiple fractures — n=41, PRR 24.9
- Splenomegaly — n=27, PRR 23.2
- Bone loss — n=33, PRR 21.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Nelfinavir?
In FDA FAERS, the most frequently co-reported reaction terms for Nelfinavir are anxiety, emotional distress, anhedonia, chronic kidney disease, osteoporosis, anaemia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Nelfinavir have an FDA boxed warning?
No. The FDA label retrieved for Nelfinavir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nelfinavir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID e72c2bc6-9462-4a2e-8e1d-b97592376cbd, effective 20251211; matched on
openfda.generic_name.exact:"NELFINAVIR MESYLATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 109 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.