Interferon Gamma-1B side effects: what 1,395 FDA adverse event reports show

Interferon Gamma-1B · Actimmune · 23 reaction terms · 309 drug–reaction co-reports · data 2026-09-14

Drug class

Interferon gamma

FDA label (Established Pharmacologic Class)

Brand names

Actimmune

openFDA label

Who reports

1,395 reports · 65% serious · 202 with death outcome · 34% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).

FDA label, Indications and Usage

What it is

ACTIMMUNE (Interferon gamma-1b), an interferon gamma, is a single-chain polypeptide containing 140 amino acids. Production of ACTIMMUNE is achieved by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the recombinant protein.

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 13 strongest signals

Labeled (related wording) 3Reporting / coding artifact 4Not in label — unassessed 6

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.
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. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Influenza like illness (flu-like illness)	92	16.8 13.7–20.4ROR 17.9 · χ² 1,351 / p 5e-296	16.7 EB05 14.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.5 · 80% consumer	no trial data cached
Lymphadenopathy	27	11.5 7.9–16.7ROR 11.7 · χ² 248 / p 4e-56	10.8 EB05 7.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Mitral valve incompetence	8	10.6 5.3–21.2ROR 10.7 · χ² 60 / p 4e-15	8.0 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Abscess	11	10.4 5.8–18.7ROR 10.5 · χ² 84 / p 2e-20	8.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Therapy cessation	34	10.0 7.2–14.0ROR 10.2 · χ² 267 / p 2e-60	9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5	no trial data cached
Lung infection	9	8.6 4.5–16.5ROR 8.6 · χ² 53 / p 2e-13	6.5 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Hepatic encephalopathy	5	8.0 3.4–19.3ROR 8.1 · χ² 24 / p 4e-7	5.2 EB05 2.3 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
No therapeutic response	6	7.3 3.3–16.2ROR 7.3 · χ² 27 / p 1e-7	5.0 EB05 2.5 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Interstitial lung disease	23	7.2 4.8–10.7ROR 7.3 · χ² 116 / p 2e-27	6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4	no trial data cached
Multi-organ failure	7	6.0 2.9–12.6ROR 6.0 · χ² 24 / p 4e-7	4.5 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Wrong technique in drug usage process	8	3.3 1.6–6.5ROR 3.3 · χ² 10 / p 6e-4	2.9 EB05 1.6 · IC025 +0.3	Reporting / coding artifact	–	no trial data cached
Injection site rash	6	3.0 1.3–6.6ROR 3.0 · χ² 6 / p 0.007	2.6 EB05 1.3 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious n=2	no trial data cached
Drug dose omission	28	2.5 1.7–3.6ROR 2.5 · χ² 24 / p 4e-7	2.4 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 3.1 · 81% consumer	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
Influenza like illness (flu-like illness)	92	16.8 13.7–20.4ROR 17.9 · χ² 1,351 / p 5e-296	16.7 EB05 14.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.5 · 80% consumer	no trial data cached
Therapy cessation	34	10.0 7.2–14.0ROR 10.2 · χ² 267 / p 2e-60	9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5	no trial data cached
Drug dose omission	28	2.5 1.7–3.6ROR 2.5 · χ² 24 / p 4e-7	2.4 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 3.1 · 81% consumer	no trial data cached
Lymphadenopathy	27	11.5 7.9–16.7ROR 11.7 · χ² 248 / p 4e-56	10.8 EB05 7.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Interstitial lung disease	23	7.2 4.8–10.7ROR 7.3 · χ² 116 / p 2e-27	6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4	no trial data cached
Injection site erythema (redness where injected)	15	1.8 1.1–3.0ROR 1.8 · χ² 5 / p 0.014	1.8 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 2.6	no trial data cached
Abscess	11	10.4 5.8–18.7ROR 10.5 · χ² 84 / p 2e-20	8.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Lung infection	9	8.6 4.5–16.5ROR 8.6 · χ² 53 / p 2e-13	6.5 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Wrong technique in drug usage process	8	3.3 1.6–6.5ROR 3.3 · χ² 10 / p 6e-4	2.9 EB05 1.6 · IC025 +0.3	Reporting / coding artifact	–	no trial data cached
Mitral valve incompetence	8	10.6 5.3–21.2ROR 10.7 · χ² 60 / p 4e-15	8.0 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Multi-organ failure	7	6.0 2.9–12.6ROR 6.0 · χ² 24 / p 4e-7	4.5 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Injection site rash	6	3.0 1.3–6.6ROR 3.0 · χ² 6 / p 0.007	2.6 EB05 1.3 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious n=2	no trial data cached
No therapeutic response	6	7.3 3.3–16.2ROR 7.3 · χ² 27 / p 1e-7	5.0 EB05 2.5 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Hepatic encephalopathy	5	8.0 3.4–19.3ROR 8.1 · χ² 24 / p 4e-7	5.2 EB05 2.3 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Drug effective for unapproved indication	4	2.1 0.8–5.5ROR 2.1 · χ² 1 / p 0.132	1.9 EB05 0.8 · IC025 -0.9 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=2	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.

Lymphadenopathy — n=27, PRR 11.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Interferon beta-1a ↔ Influenza-like illness.

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 Interferon Gamma-1B?

In FDA FAERS, the most frequently co-reported reaction terms for Interferon Gamma-1B are influenza like illness, lymphadenopathy, interstitial lung disease, injection site erythema, abscess, lung infection. 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 Interferon Gamma-1B have an FDA boxed warning?

No. The FDA label retrieved for Interferon Gamma-1B has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Interferon Gamma-1B 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 5d0b1256-1981-4519-94f4-a4a2f98bd8a3, effective 20260330; matched on openfda.generic_name.exact:"INTERFERON GAMMA-1B")
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, field patient.drug.openfda.generic_name.exact, 23 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.