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What the label lists and what reports show

Interferon gamma 1b side effects

Interferon gamma 1b's FDA label: “The most common adverse reactions observed in patients with CGD are shown in the following table: Table 2: Adverse Reactions Occurring in 2% or Greater of CGD Patients Receiving ACTIMMUNE in Clinical Trials Adverse Reactions Percent of Patients ACTIMMUNE CGD …” FAERS holds 1,395 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 pyrexia (193 reports).

  • No generic listed

Check it at the source: the interferon gamma 1b FDA label on DailyMed (effective March 30, 2026, Horizon Therapeutics USA, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions observed in patients with CGD are shown in the following table: Table 2: Adverse Reactions Occurring in 2% or Greater of CGD Patients Receiving ACTIMMUNE in Clinical Trials Adverse Reactions Percent of Patients ACTIMMUNE CGD (n=63) Placebo CGD (n=65) Fever 52 28 Headache 33 9 Rash 17 6 Chills 14 0 Injection site erythema or tenderness 14 2 Fatigue 14 11 Diarrhea 14 12 Vomiting 13 5 Nausea 10 2 Myalgia 6 0 Arthralgia 2 0 Similar safety data were observed in 34 patients with SMO.

Table 2: Adverse Reactions Occurring in 2% or Greater of CGD Patients Receiving ACTIMMUNE in Clinical Trials

ReactionAdverse Reactions ACTIMMUNE CGD (n=63)Percent of Patients Placebo CGD (n=65)
Fever5228
Headache339
Rash176
Chills140
Injection site erythema or tenderness142
Fatigue1411
Diarrhea1412
Vomiting135
Nausea102
Myalgia60
Arthralgia20

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, continued

The following adverse reactions are described below and elsewhere in the warnings and precautions section of the labeling: Cardiovascular Disorders [see Warnings and Precautions (5.1) ] Neurologic Disorders [see Warnings and Precautions (5.2) ] Bone Marrow Toxicity [see Warnings and Precautions (5.3) ] Hepatic Toxicity [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Renal Toxicity [see Warnings and Precautions (5.6) ] Common adverse reactions (incidence rate 2% or greater) for ACTIMMUNE include fever, headache, rash, chills, injection site erythema or tenderness, fatigue, diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc.at 1 800 77 AMGEN (1 800 772 6436)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 practice. The following data on adverse reactions are based on the subcutaneous administration of ACTIMMUNE at a dose of 50 mcg/m 2 , three times weekly, in patients with CGD during a clinical trial in the United States and Europe.

Source: FDA drug label, Horizon Therapeutics USA, Inc., effective March 30, 2026 (SPL set 5d0b1256-1981-4519-94f4-a4a2f98bd8a3), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,395 reports list interferon gamma 1b among the medicines taken, each a report of something that happened, not proof the medicine caused it; 202 are coded as a death and 539 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. Of the 18 reactions below, 11 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

  • Pyrexia193
  • Off Label Use (a use or a product term, not a reaction)177
  • Pneumonia100
  • Influenza Like Illness (named in the label)92
  • Fatigue (named in the label)68
  • Death (an outcome recorded in the report)61
  • Headache (named in the label)61
  • Chills (named in the label)55
  • Malaise (named in the label)51
  • Pain49
  • Nausea (named in the label)48
  • Dyspnoea45
  • Infection (a use or a product term, not a reaction)40
  • Vomiting (named in the label)40
  • Hospitalisation (an outcome recorded in the report)37
  • Neutropenia (named in the label)37
  • Anaemia36
  • Disease Progression (a use or a product term, not a reaction)35
  • Condition Aggravated (a use or a product term, not a reaction)34
  • Therapy Cessation34
  • Injection Site Pain (named in the label)32
  • Weight Decreased (named in the label)30
  • Diarrhoea (named in the label)29
  • Respiratory Failure29
  • Drug Dose Omission (a use or a product term, not a reaction)28

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Interferon gamma 1b: the full record
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Side effects hub
the most reported medicines and reactions