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What the label lists and what reports show

Penicillamine side effects

Penicillamine's FDA label lists its adverse reactions in its own words. FAERS holds 922 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 drug hypersensitivity (180 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the penicillamine FDA label on DailyMed (effective January 26, 2026, Bausch Health US, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Penicillamine is a drug with a high incidence of untoward reactions, some of which are potentially fatal. Therefore, it is mandatory that patients receiving penicillamine therapy remain under close medical supervision throughout the period of drug administration (see WARNINGS and PRECAUTIONS ). Reported incidences (%) for the most commonly occurring adverse reactions in rheumatoid arthritis patients are noted, based on 17 representative clinical trials reported in the literature (1270 patients). Allergic Generalized pruritus, early and late rashes (5%), pemphigus (see WARNINGS ), and drug eruptions, which may be accompanied by fever, arthralgia, or lymphadenopathy have occurred (see WARNINGS and PRECAUTIONS ). Some patients may show a lupus erythematosus-like syndrome similar to drug-induced lupus produced by other pharmacological agents (see PRECAUTIONS ). …

Source: FDA drug label, NDA019853 (Valeant Pharms Intl), as published by Bausch Health US, LLC, effective January 26, 2026 (SPL set 80e736d3-2017-4d68-94b4-38255c3c59c6), via openFDA; the full label on DailyMed

What do FAERS reports show?

922 reports list penicillamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 90 are coded as a death and 245 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 21 reactions below, 6 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

  • Drug Hypersensitivity180
  • Drug Ineffective (a use or a product term, not a reaction)176
  • Arthralgia (named in the label)150
  • Joint Swelling144
  • Inflammation111
  • Nausea (named in the label)96
  • Off Label Use (a use or a product term, not a reaction)94
  • Diarrhoea (named in the label)90
  • Headache83
  • Hypersensitivity81
  • Drug Intolerance79
  • Anaphylactic Reaction77
  • Urticaria (named in the label)71
  • Treatment Failure (a use or a product term, not a reaction)69
  • Acute Kidney Injury68
  • Cardiovascular Disorder67
  • Chest Pain67
  • Red Blood Cell Sedimentation Rate Increased67
  • Proteinuria (named in the label)65
  • Pain63
  • Contraindicated Product Administered62
  • Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis56
  • Rheumatoid Arthritis (a use or a product term, not a reaction)53
  • Vasculitis (named in the label)52
  • Weight Decreased45

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

What next?

Penicillamine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions