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What the label lists and what reports show

Penicillin g benzathine side effects

Penicillin g benzathine's FDA label lists its adverse reactions in its own words. FAERS holds 1,343 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 recalled product administered (572 reports).

  • No generic listed
  • In shortage
  • Boxed warning

Check it at the source: the penicillin g benzathine FDA label on DailyMed (effective July 21, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria. As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported. The following adverse reactions have been reported with Bicillin L-A during post-marketing experience: Skin and Appendages: Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS). (See WARNINGS .) Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction. …

Source: FDA drug label, NDA050141 (King Pharms Llc), as published by Pfizer Laboratories Div Pfizer Inc, effective July 21, 2026 (SPL set 012d46f1-d0a0-4676-a879-cd320297ab16), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,343 reports list penicillin g benzathine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 39 are coded as a death and 240 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 19 reactions below, 9 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

  • Recalled Product Administered572
  • Drug Hypersensitivity67
  • Injection Site Pain63
  • Off Label Use (a use or a product term, not a reaction)45
  • Embolia Cutis Medicamentosa44
  • Pain43
  • Drug Ineffective (a use or a product term, not a reaction)33
  • Acute Kidney Injury31
  • Rash (named in the label)28
  • No Adverse Event (a use or a product term, not a reaction)25
  • Headache (named in the label)24
  • Injection Site Swelling23
  • Pyrexia23
  • Diarrhoea (named in the label)22
  • Hypersensitivity (named in the label)20
  • Dizziness (named in the label)19
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)19
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)19
  • Fatigue (named in the label)18
  • Jarisch-Herxheimer Reaction (named in the label)18
  • Premature Baby18
  • Anxiety (named in the label)16
  • Chest Pain16
  • Dyspnoea (named in the label)16
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)16

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

What next?

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