What the label lists and what reports show

Cefotetan side effects

Cefotetan's FDA label lists its adverse reactions in its own words. FAERS holds 143 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 haemolytic anaemia (20 reports).

Generic listed

Check it at the source: the cefotetan FDA label on DailyMed (effective April 8, 2024, PAI Holdings, LLC dba PAI Pharma); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
In clinical studies, the following adverse effects were considered related to CEFOTAN therapy. Those appearing in italics have been reported during postmarketing experience. Gastrointestinal: symptoms occurred in 1.5% of patients, the most frequent were diarrhea (1 in 80) and nausea (1 in 700); pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment or surgical prophylaxis (see WARNINGS ). Hematologic: laboratory abnormalities occurred in 1.4% of patients and included eosinophilia (1 in 200), positive direct Coombs test (1 in 250), and thrombocytosis (1 in 300); agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia, and prolonged prothrombin time with or without bleeding. …

Source: FDA drug label, PAI Holdings, LLC dba PAI Pharma, effective April 8, 2024 (SPL set f1510f5e-d001-44e0-accb-27cf79fd4f9a), via openFDA; the full label on DailyMed

What do FAERS reports show?

143 reports list cefotetan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 71 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 25 reactions below, 7 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.

The 25 most reported reactions

Haemolytic Anaemia (named in the label)20
Nausea (named in the label)10
Dyspnoea9
Renal Failure9
Abdominal Pain (named in the label)8
Asthenia8
Chronic Kidney Disease8
Hypertension8
Urticaria (named in the label)8
Anaemia (named in the label)7
Dizziness7
Haemoglobin Decreased7
Pain7
Anaphylactic Reaction (named in the label)6
Anxiety6
Injury6
Weight Decreased6
Chest Discomfort5
Depression5
End Stage Renal Disease5
Jaundice5
Paraesthesia5
Thrombocytopenia (named in the label)5
Tremor5
Acute Kidney Injury4

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

What next?

Cefotetan: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions