Zemimet SR Adverse Reactions

There have been no therapeutic clinical trials conducted with Zemimet SR tablets, however bioequivalence of Zemimet SR with co-administered gemigliptin and metformin has been demonstrated.
Zemimet SR: Post-marketing surveillance: Table 2 presents adverse reactions which have been reported during post-marketing surveillance. The adverse reactions are listed by SOC and PT with frequency.
Frequencies are defined as Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1,000), or not known (cannot be estimated from the available data). (See Table 2.)

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Spontaneous global post-marketing reports: The following adverse reactions have been additionally reported during post-marketing use of the product. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaemia, Palpitations, Tinnitus, Vertigo, Eye pain, Macular oedema, Abdominal discomfort, Abdominal distension, Abdominal pain, Constipation, Diarrhoea, Dry mouth, Vomiting, Asthenia, Chills, Discomfort, Drug ineffective, Face oedema, Fatigue, Oedema, Oedema peripheral, Pain, Treatment noncompliance, Hypersensitivity, Pyelitis, Rhinitis, Vaginal infection.
Gemigliptin: There were 2,281 patients with type 2 diabetes, including 1,351 patients that were randomized into gemigliptin group in 10 controlled clinical safety and efficacy studies conducted to evaluate the effects of gemigliptin on glycemic control.
Safety data were collected from a total of 1,606 patients exposed to gemigliptin at a dose of 50 mg per day in controlled clinical trials of monotherapy or combination therapy of 12 weeks or more. Of these patients, 221 patients received gemigliptin alone and 1,385 received it in combination with other medications.
Serious adverse reactions related to gemigliptin have not been reported in all 10 clinical studies. 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.
Tabulated summary of adverse reactions: Table 3 presents adverse reactions for over 12 weeks which have been reported from the pooled analysis of 10 randomized, controlled clinical studies. The adverse reactions are listed by SOC (system organ class) and PT (Preferred Term) with frequency.
Frequencies are defined as Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1,000), or not known (cannot be estimated from the available data). (See Table 3.)

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Post-marketing surveillance: Table 4 presents adverse reactions which have been reported during post-marketing surveillance. The adverse reactions are listed by SOC and PT with frequency.
Frequencies are defined as Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1,000), or not known (cannot be estimated from the available data). (See Table 4.)

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Spontaneous global post-marketing reports: The following adverse reactions have been additionally reported during post-marketing use of the product. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Pneumonia, Vomiting, Edema peripheral, Asthenia, Stevens-Johnson syndrome, Rash pruritic, Pyrexia, Gastritis, Arthralgia, Swelling face, Lip swelling, Pancreatitis.
Description of selected adverse reactions: Hypoglycemia: Hypoglycemia was commonly reported in controlled clinical trials of gemigliptin over 12 weeks. In all studies, the majority of reported hypoglycemia was mild and recovered. The incidence of hypoglycemia was similar among treatment groups, including placebo, in all studies. The incidence of hypoglycemia was higher in the sulfonylurea and insulin add-on studies compared to the other studies.
Pancreatitis: Although pancreatitis has not been reported, increased levels of lipase, for which a causal relationship with gemigliptin cannot be ruled out, have been reported, though uncommonly. In the results of controlled clinical trials of monotherapy and combination therapy over 12 weeks with gemigliptin, increased lipase levels were observed in 0.6% of patients, which were mild or moderate, and most recovered.
Hypersensitivity: Hypersensitivity reactions related to gemigliptin have not been reported in all 10 clinical studies.
Bullous pemphigoid: There have been post-marketing reports of bullous pemphigoid requiring hospitalization in patients taking other DPP-4 inhibitors. There have been no reports of bullous pemphigoid in monotherapy and combination therapy controlled clinical trials of gemigliptin of 12 weeks or longer.