Philippe Camus, M.D.

Dijon, France

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Hydralazine

Frequency - Incidence

Incidence of respiratory adverse event(s) due to the specific drug as assessed by number of reported/published cases in the literature. Red digits in stars indicate: 0 = Very rare, questionable signal · 1 = < 10 cases · 2 = 10-50 cases · 3 = 50–100 cases · 4 = 100-200 cases · 5 = >200 cases

Evidence level/grade

Evidence level for respiratory adverse event(s) due to the specific drug as estimated using Hill’s (1965), Naranjo’s (1981), and Bégaud’s (1985) criteria applied to published cases. Blue digits in stars indicate: 0 = Questionable · 1 = Low · 2 = Moderate · 3 = Robust · 4 = Definite · 5 = Unquestionable, pathognomonic

I - Interstitial/parenchymal lung disease

I.a

Pneumonitis (ILD)
I.b

Pneumonitis (ILD), acute and/or severe (may cause ARDS)
I.e

Organizing pneumonia pattern (an area or areas of consolidation on imaging)

II - Pulmonary edema - Acute lung injury - ARDS

II.e

ARDS - Acute lung injury

III - Pulmonary/alveolar./airway hemorrhage/bleeding

III.a

Alveolar hemorrhage (AH), diffuse AH (DAH)
III.b

Pneumorenal syndrome (w/wo ANCAs)
III.d

Alveolar hemorrhage, diffuse (ANCA-positive/-related)

IV - Airway involvement

IV.a

Bronchospasm - Wheezing - Asthma
IV.i

Occupational asthma

V - Central-large-upper airway (incl. pharyngeal-nasal) involvement

V.a

Angioedema (may cause UAO, asphyxia and death)
V.c

Upper airway obstruction other than angioedema or hematoma
V.f

Vocal cord dysfunction, adduction, closure, injury

VI - Pleural and/or pericardial involvement

VI.d

Pleural/pericardial effusion, ANA positive (DI lupus)
VI.i

Pleuritis (can cause chest pain)
VI.m

Pleuropericarditis - Pleuropericardial effusion (ANA unknown or negative)

VII - Pulmonary vasculopathy

VII.d

Pulmonary vasculitis or capillaritis

X - Systemic/Distant conditions, syndromes and reactions

X.a

DRES syndrome - DRESS-like reaction
X.b

Antiphospholipid antibodies w/wo the APL syndrome
X.d

Lupus - Lupus syndrome (see also Vd)
X.e

Autoimmunity-Autoimmune conditions (+ANA, +anti-ds-DNA, +ANCAs, other auto-Abs)
X.o

Vascultis (pulmonary, extrathoracic or systemic)-ANCA status unknown or negative)
X.q

Neutrophilic dermatosis (Pyoderma, Sweet syndrome)
X.u

Vasculitis, pulmonary (w/wo AH), extrapulmonary, systemic: ANCA-positive
X.am

Dual MPO-/PR3-ANCA systemic disease/vasculitis/pseudovasculitis

XII - Cardiovascular involvement / toxicity

XII.c

Pericardial effusion (w/wo tamponade)
XII.l

Constrictive pericarditis - Pericardial thickening

XIX - Pathology

XIX.o

Path: Diffuse alveolar damage (DAD-pattern) (see also IL)