p>Adverse drug reactions (ADRs) can lead to the interruption of tuberculosis (TB) treatment, and contribute to regimen failure, morbidity, loss in quality of life or death. ADRs due to TB medicines are well known, but the overall contribution of anti-TB medicines to the burden of disease and patient mortality has been poorly studied. While many national TB programmes have a long tradition of monitoring patient care, the surveillance of drug-related problems, or pharmacovigilance, has not been systematic. Why should TB programmes today consider reinforcing pharmacovigilance? The increasing worldwide use of more extensive regimens for drug-resistant TB, the concomitant use of antiretroviral therapy in patients with HIV-associated TB, and the imminent release on the market of new classes of medicines to treat TB make the case for pharmacovigilance even stronger. This handbook provides the practitioner with a step-by-step approach to the different methodologies available to include pharmacovigilance activities as a standard of care for TB patients.