What the label lists and what reports show
Pimecrolimus side effects
Pimecrolimus's FDA label: “The most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection.” FAERS holds 1,704 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 dermatitis atopic (200 reports).
- Generic listed
- Boxed warning
Check it at the source: the pimecrolimus FDA label on DailyMed (effective April 30, 2026, Oceanside Pharmaceuticals); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Pimecrolimus Cream, 1%?Pimecrolimus Cream, 1% may cause serious side effects. • See “ What is the most important information I should know about Pimecrolimus Cream, 1%? ” • The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Other common side effects include: • headache • common cold or stuffy nose, sore throat • cough • flu (influenza) • fever • viral infection. Some people may get viral skin infections (like cold sores, chickenpox, shingles, or warts) or swollen lymph nodes (glands). Tell your doctor if you get a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away. These are not all the possible side effects with Pimecrolimus Cream, 1%. […]
Source: FDA drug label, NDA021302 (Bausch), as published by Oceanside Pharmaceuticals, effective April 30, 2026 (SPL set 6601e43e-ce7d-446a-8568-8e7b24b86f06), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection.
Table 1. Treatment Emergent Adverse Events (≥1%) in Pimecrolimus Cream, 1% Treatment Groups
| Reaction | Pimecrolimus Cream, 1% (N=267) N (%) | Vehicle (N=136) N (%) | Pimecrolimus Cream, 1% (N=335) N (%) | Pimecrolimus Cream, 1% (N=272) N (%) | Vehicle (N=75) N (%) | Pimecrolimus Cream, 1% (N=328) N (%) |
|---|---|---|---|---|---|---|
| At least 1 AE | 182 (68.2%) | 97 (71.3%) | 240 (72.0%) | 230 (84.6%) | 56 (74.7%) | 256 (78.0%) |
| Upper Respiratory Tract Infection NOS | 38 (14.2%) | 18 (13.2%) | 65 (19.4%) | 13 (4.8%) | 6 (8.0%) | 14 (4.3%) |
| Nasopharyngitis | 27 (10.1%) | 10 (7.4%) | 32 (19.6%) | 72 (26.5%) | 16 (21.3%) | 25 (7.6%) |
| Skin Infection NOS | 8 (3.0%) | 9 (5.1%) | 18 (5.4%) | 6 (2.2%) | 3 (4.0%) | 21 (6.4%) |
| Influenza | 8 (3.0%) | 1 (0.7%) | 22 (6.6%) | 36 (13.2%) | 3 (4.0%) | 32 (9.8%) |
| Ear Infection NOS | 6 (2.2%) | 2 (1.5%) | 19 (5.7%) | 9 (3.3%) | 1 (1.3%) | 2 (0.6%) |
| Otitis Media | 6 (2.2%) | 1 (0.7%) | 10 (3.0%) | 8 (2.9%) | 4 (5.3%) | 2 (0.6%) |
| Impetigo | 5 (1.9%) | 3 (2.2%) | 12 (3.6%) | 11 (4.0%) | 4 (5.3%) | 8 (2.4%) |
| Bacterial Infection | 4 (1.5%) | 3 (2.2%) | 4 (1.2%) | 3 (1.1%) | 0 | 6 (1.8%) |
| Folliculitis | 3 (1.1%) | 1 (0.7%) | 3 (0.9%) | 6 (2.2%) | 3 (4.0%) | 20 (6.1%) |
| Sinusitis | 3 (1.1%) | 1 (0.7%) | 11 (3.3%) | 6 (2.2%) | 1 (1.3%) | 2 (0.6%) |
| Pneumonia NOS | 3 (1.1%) | 1 (0.7%) | 5 (1.5%) | 0 | 1 (1.3%) | 1 (0.3%) |
| Pharyngitis NOS | 2 (0.7%) | 2 (1.5%) | 3 (0.9%) | 22 (8.1%) | 2 (2.7%) | 3 (0.9%) |
| Pharyngitis Streptococcal | 2 (0.7%) | 2 (1.5%) | 10 (3.0%) | 0 | <1% | 0 |
| Molluscum Contagiosum | 2 (0.7%) | 0 | 4 (1.2%) | 5 (1.8%) | 0 | 0 |
| Staphylococcal Infection | 1 (0.4%) | 5 (3.7%) | 7 (2.1%) | 0 | <1% | 3 (0.9%) |
| Bronchitis NOS | 1 (0.4%) | 3 (2.2%) | 4 (1.2%) | 29 (10.7%) | 6 (8.0%) | 8 (2.4%) |
| Herpes Simplex | 1 (0.4%) | 0 | 4 (1.2%) | 9 (3.3%) | 2 (2.7%) | 13 (4.0%) |
| Tonsillitis NOS | 1 (0.4%) | 0 | 3 (0.9%) | 17 (6.3%) | 0 | 2 (0.6%) |
| Viral Infection NOS | 2 (0.7%) | 1 (0.7%) | 1 (0.3%) | 18 (6.6%) | 1 (1.3%) | 0 |
| Gastroenteritis NOS | 0 | 3 (2.2%) | 2 (0.6%) | 20 (7.4%) | 2 (2.7%) | 6 (1.8%) |
| Chickenpox | 2 (0.7%) | 0 | 3 (0.9%) | 8 (2.9%) | 3 (4.0%) | 1 (0.3%) |
| Skin Papilloma | 1 (0.4%) | 0 | 2 (0.6%) | 9 (3.3%) | <1% | 0 |
| Tonsillitis Acute NOS | 0 | 0 | 0 | 7 (2.6%) | 0 | 0 |
| Upper Respiratory Tract Infection Viral NOS | 1 (0.4%) | 0 | 3 (0.9%) | 4 (1.5%) | 0 | 1 (0.3%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. No phototoxicity and no photoallergenicity were detected in clinical trials with 24 and 33 normal volunteers, respectively. In human dermal safety trials, Pimecrolimus Cream, 1% did not induce contact sensitization or cumulative irritation. In a 1-year safety trial in pediatric subjects age 2-17 years old involving sequential use of Pimecrolimus Cream, 1% and a topical corticosteroid, 43% of Pimecrolimus Cream, 1% treated subjects and 68% of vehicle-treated subjects used corticosteroids during the trial. Corticosteroids were used for more than 7 days by 34% of Pimecrolimus Cream, 1% treated subjects and 54% of vehicle-treated subjects. …
Source: FDA drug label, NDA021302 (Bausch), as published by Oceanside Pharmaceuticals, effective April 30, 2026 (SPL set 6601e43e-ce7d-446a-8568-8e7b24b86f06), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,704 reports list pimecrolimus among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 192 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 17 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pimecrolimus: 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