What the label lists and what reports show

Ammonium lactate side effects

Ammonium lactate's FDA label lists its adverse reactions in its own words. FAERS holds 2,119 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 fatigue (149 reports).

Generic listed

Check it at the source: the ammonium lactate FDA label on DailyMed (effective November 30, 2025, Padagis Israel Pharmaceuticals Ltd); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with ammonium lactate cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with ammonium lactate cream were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

Source: FDA drug label, Padagis Israel Pharmaceuticals Ltd, effective November 30, 2025 (SPL set 7096d38e-2bd1-4374-9bf6-7fd09ef7509c), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,119 reports list ammonium lactate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 175 are coded as a death and 578 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, 1 is 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

Fatigue149
Pain148
Diarrhoea140
Drug Ineffective (a use or a product term, not a reaction)134
Chronic Kidney Disease127
Nausea126
Dyspnoea115
Rash (named in the label)110
Fall109
Headache104
Renal Failure100
Anxiety97
Death (an outcome recorded in the report)92
Acute Kidney Injury91
Dizziness91
Pruritus87
Arthralgia85
Off Label Use (a use or a product term, not a reaction)84
Pain In Extremity77
Vomiting75
Product Dose Omission Issue (a use or a product term, not a reaction)69
Back Pain67
Constipation67
Weight Decreased67
Emotional Distress64

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

What next?

Ammonium lactate: 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