In clinical trials, the most common adverse events which occurred at a rate ≥5% and ≥1.5 times placebo included paraesthesia (tingling in fingers/toes), dizziness, altered taste, insomnia, constipation, and dry mouth. In the U.S., the drug label contains warnings for increased heart rate, suicidal behavior and ideation, glaucoma, mood and sleep disorders, creatine elevation, and metabolic acidosis. Some of these warnings are based on historical observations in epilepsy patients taking<unk> . The FDA is requiring the company to perform a post-approval cardiovascular outcomes trial, due in part to the observation of increased heart rate in some people taking the drug in clinical trials. Pregnancy<unk>  and<unk>  can cause fetal harm. Data from pregnancy registries and epidemiology studies indicate that a fetus exposed to<unk>  in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). If a patient becomes pregnant while taking<unk>  ER, treatment should be discontinued immediately, and the patient should be apprised of the potential hazard to a fetus. Females of reproductive potential should have a negative pregnancy test before starting<unk>  ER and monthly thereafter during<unk>  ER therapy. Females of reproductive potential should use effective contraception during<unk>  ER therapy. Risk evaluation and mitigation strategy<unk>  and<unk>  was approved with a risk evaluation and mitigation strategy (REMS) program to ensure that benefits of treatment outweigh the risks. Because of the teratogenic risk associated with<unk>  ER therapy,<unk>  ER is distributed via certified pharmacies.
Phentermine/topiramate
Brinzolamide/brimonidine
Brimonidine/timolol
Zonisamide
Topiramate
Amitriptyline/chlordiazepoxide
Primidone
Valproate pivoxil