Table 4.
Summary of published literature reporting fidaxomycin hypersensitivity.
| Reaction | Time of Onset # | Demographics | Dosage Form | Concomitant Agents | Allergy Evaluation/Confirmation | Prior Sensitization | Notes |
|---|---|---|---|---|---|---|---|
| Diffuse rash [132] | 5 days | 73 y/o M | PO | NR | N | N | |
| Rash, swollen eyes and lips [132] | 1–2 h | 74 y/o F | PO | NR | N | N | |
| Diffuse rash [132] | 5 days | 26 y/o F | PO | NR | N | N | |
| Diffuse rash and itching [132] | 1 h | 49 y/o F | PO | NR | N | Y (E and A allergy) | Cross reactivity with FDX, E, A. |
| Throat burning [132] | 12–24 h | 79 y/o F | PO | NR | N | Y (E allergy) | |
| Throat and chest swelling [132] | 2 days; N | F, age NR | PO | NR | Y (DPT+) | Y (F 30 days prior; E allergy) | |
| Eyes, lips, mouth swelling, itchy face [132] | 72 h | 53 y/o F | PO | NR | N | N | |
| Angioedema [132] | 5 days, 6 days |
56 y/o M | PO | NR | Y (DPT+) | Y (FDX same reaction within 24 h) | |
| Lip swelling [132] | 7 days | F, age NR | PO | NR | N | N | |
| Severe rash [132] | NR | M, age NR | PO | NR | N | N | |
| SOB, throat swelling, chest tightness [132] | 2 days | 50 y/o F | PO | NR | N | N | |
| BLE edema and rash [132] | 5 days | 70 y/o M | PO | NR | N | N | |
| MAS [46] | NR | n = 6, <18 y/o and, gender NR | PO | N | Y (PT+, DPT+) | NR | |
| ACDR [77] | NR | NR | NR | NR | N | NR | |
| MAS [133] | NR | n = 34, age and gender NR | NR | NR | N | NR | |
| + DPT with ADR [134] | NR | n = 102, age and gender NR | NR | NR | Y (n = 14, DPT+) | NR | |
| ADRs [97] | NR | n = 4 (<18 y/o), gender NR | NR | NR | Y (NR) | NR |
Abbreviations: ACDR = acute cutaneous drug reaction¤; ADR = adverse drug reaction; AGEP = acute generalized exanthematous pustulosis; APAP = acetaminophen; ASA = aspirin; A = azithromycin; C = clarithromycin; CD = contact dermatitis; DR = delayed reaction; DPT = drug provocation test; DRESS = Drug reaction with eosinophilia and systemic symptoms syndrome; E = erythromycin; EM = erythema multiforme; ER = extended release; ETH = ethambutol; F = female; FDX = fidaxomicin; HRT = leukocyte histamine release test; HSP = Henoch- Schönlein Purpura; h = hour(s); HCTZ = hydrochlorothiazide; HIV = human immunodeficiency virus; IBU = ibuprofen; IDT = intradermal test; Ig E = immunoglobulin E; IM = intramuscular; IR = immediate reaction (<1 hr); LABD = Linear Immunoglobulin A Bullous Dermatosis; LCV = leukocytoclastic vasculitis; LTT = lymphocyte transformation test; MAS = multiple allergy sensitivity; MDT = mast cell degranulation test; min= minutes; mo = months; MMIT = macrophage migration inhibitory test; MPE= maculopapular exanthema; MPR = maculopapular rash; N = no; NIR= nonimmediate reaction (1–72 h); NR= not reported; NTG = nitroglycerin; opth = ophthalmic; PT = patch test; R = roxithromycin; RIF = rifampin; RFB = rifabutin; S = spiramycin; SJS = Steven’s Johnson syndrome; SOB = shortness of breath; SPT = skin prick test; ST = scratch test; TEN = toxic epidermal necrolysis; TMP/SMX= trimethoprim/sulfamethoxazole; top = topical; wks = weeks; Y = yes; yrs = years; y/o = years old. * Exact time course unknown as awoke with FDE. # Time of onset means time when symptoms began to occur either during macrolide therapy or after completion of macrolide therapy. ACDR defined as allergic reaction, adverse drug reaction, pruritis, general swelling, local or general redness, erythema, rash, urticaria, or other skin disease. π Review was meant to include azithromycin, clarithromycin, erythromycin, and fidaxomicin; however, there is a chance these data include excluded macrolides since the type of macrolides reported were not fully specified.