[Obat Off-label merupakan obat yang diresepkan tidak sesuai dengan ketentuan izin edar termasuk indikasi, dosis, kontraindikasi, usia, dan rute pemberian. Penelitian ini dilakukan untuk mengevaluasi pola penggunaan obat off-label untuk pasien usia 0 sampai 2 tahun di Instalasi Rawat Jalan Rumah Sakit Umum Pusat Fatmawati periode Maret 2015. Penelitian ini menggunakan design studi cross-sectional dan data diambil dari resep dan rekam medis periode Maret 2015 dengan teknik total sampling. Sampel penelitian adalah data pasien usia 0 sampai 2 tahun yang menerima obat pada periode Maret 2015. Evaluasi dilakukan terhadap 156 terapi obat dari 25 jenis obat yang digunakan pada 64 pasien dari 113 pasien dengan pasien usia kurang dari 1 bulan (5%) dan pasien usia >1 bulan sampai 2 tahun (95%) terdiri atas laki-laki atau perempuan sebesar 50% serta diagnosis terbanyak adalah epilepsy (36%). Terdapat 8 jenis obat dengan 55 terapi obat. Proporsi kategori off-label dosis sebanyak 20 terapi obat (36%) dengan penggunaan tertinggi adalah sefiksim (50%) dan off-label usia sebanyak 35 terapi obat (64%) dengan penggunaan tertinggi adalah asam valproat (80%). Berdasarkan hasil penelitian, penggunaan obat off-label lebih tinggi pada pasien 1 bulan-2 tahun dan golongan obat yang paling banyak digunakan adalah obat golongan saluran pernapasan sebanyak 5 jenis obat (63%).;Off-label drug is a prescribed drug that unsuitable with official drug information, and patient age, drug indications, dosage, and route of administration that are not appropriate. This study aimed to evaluate of off-label drugs use in under 2-year-old patients in Fatmawati General Hospital on March 2015. Sample data was data of under recieving drug therapy on march 2015. Cross-sectional was used and data were collected by total sampling from prescriptions and medical records. Sample are data 2-year-old patients that recieve drug on March 2015. Sample were 156 drug therapy of 25 item drugs that were used in 64 patients from 113 patients that consist of patient under 1 month (5%) and after 1 month until 2 years (95%) with boys as big as girls (50%) and the highest diagnostic was epilepsy (36%).There were 8 items drugs with 55 off-label drug therapy that consist of 20 (36%) off-label doses with sefiksim was the highest used and 35 (64%) off-label age with valproic acid was the highest used. Based on the results, off-label drug use was higher (63%) in babies and respiratory system drug class was the most frequently used drug in those patients which is 5 item drugs that used., Off-label drug is a prescribed drug that unsuitable with official drug information, and patient age, drug indications, dosage, and route of administration that are not appropriate. This study aimed to evaluate of off-label drugs use in under 2-year-old patients in Fatmawati General Hospital on March 2015. Sample data was data of under recieving drug therapy on march 2015. Cross-sectional was used and data were collected by total sampling from prescriptions and medical records. Sample are data 2-year-old patients that recieve drug on March 2015. Sample were 156 drug therapy of 25 item drugs that were used in 64 patients from 113 patients that consist of patient under 1 month (5%) and after 1 month until 2 years (95%) with boys as big as girls (50%) and the highest diagnostic was epilepsy (36%).There were 8 items drugs with 55 off-label drug therapy that consist of 20 (36%) off-label doses with sefiksim was the highest used and 35 (64%) off-label age with valproic acid was the highest used. Based on the results, off-label drug use was higher (63%) in babies and respiratory system drug class was the most frequently used drug in those patients which is 5 item drugs that used.]