Studi Farmakovigilans terhadap Efek Samping Pengobatan Antituberkulosis pada Pasien Tuberkulosis Paru (Penelitian Dilakukan di Poli Paru RSUD Haji Provinsi Jawa Timur)

Tuberkulosis (TB) masih menjadi salah satu permasalahan kesehatan masyarakat di Indonesia. Penggunaan Obat Antituberkulosis (OAT) lini pertama efektif dalam pengobatan TB, tetapi berpotensi menimbulkan efek samping yang dapat menurunkan kepatuhan dan keberhasilan terapi. Farmakovigilans diperlukan untuk mendeteksi, mengevaluasi, dan mencegah efek samping obat selama pengobatan. Penelitian ini bertujuan menggambarkan profil farmakovigilans terhadap efek samping Obat Antituberkulosis pada pasien tuberkulosis paru sensitif obat di RSUD Haji Provinsi Jawa Timur. Penelitian ini merupakan penelitian observasional deskriptif dengan pendekatan retrospektif menggunakan data rekam medis 183 pasien tuberkulosis paru sensitif obat periode Januari–Desember 2025. Data meliputi karakteristik pasien, regimen OAT, lama pengobatan, hasil pemeriksaan SGOT, SGPT, serta efek samping obat, kemudian dianalisis secara deskriptif. Hasil penelitian menunjukkan bahwa mayoritas pasien berusia 46–55 tahun (22,4%) berjenis kelamin laki-laki (50,3%) dan IMT kategori normal (43,2%). Regimen yang paling banyak digunakan adalah Kombinasi Dosis Tetap (RHZE/RH) (76,5%) dengan lama pengobatan 0–168 hari (55,2%). Pada hasil pemeriksaan SGOT (10,9%), SGPT (7,1%) mengalami ditas normal. Efek samping yang paling sering ditemukan adalah mual (32,3%), muntah (19,1%), gatal (14,2%), Mayoritas efek samping tergolong ringan. Disimpulkan bahwa penggunaan OAT lini pertama pada pasien tuberkulosis paru sensitif obat memiliki profil keamanan yang baik. Namun, penerapan farmakovigilans melalui pemantauan klinis dan laboratorium secara berkala tetap diperlukan untuk mendeteksi efek samping sejak dini, meningkatkan kepatuhan pasien, dan mendukung keberhasilan terapi.

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Tuberculosis (TB) remains one of the public health issues in Indonesia. The use of first-line Antituberculosis Drugs (OAT) is effective in treating TB, but it has the potential to cause side effects that can reduce adherence and therapy success. Pharmacovigilance is necessary to detect, evaluate, and prevent drug side effects during treatment. This study aims to describe the pharmacovigilance profile of side effects from antituberculosis drugs in drug-sensitive pulmonary tuberculosis patients at Haji Regional General Hospital, East Java Province. This descriptive observational study used a retrospective approach and medical record data from 183 drug-sensitive pulmonary tuberculosis patients from January to December 2025. The data include patient characteristics, OAT regimen, treatment duration, SGOT and SGPT results, and drug side effects, which were analyzed descriptively. The results show that most patients are aged 46–55 years (22.4%), male (50.3%), and have a normal BMI (43.2%). The most commonly used regimen is the Fixed-Dose Combination (RHZE/RH) (76.5%) with a treatment duration of 0–168 days (55.2%). In the examination results, SGOT (10.9%) and SGPT (7.1%) were above normal. The most common side effects were nausea (32.3%), vomiting (19.1%), and itching (14.2%). Most side effects were classified as mild. The study concludes that first-line antituberculosis drugs have a good safety profile in drug-sensitive pulmonary tuberculosis patients. However, pharmacovigilance through regular clinical and laboratory monitoring remains necessary to detect side effects early, improve patient compliance, and support therapeutic success.