Granada Adverse Reactions

Lurasidone has been evaluated for safety at doses of 20 mg, 40 mg, 80 mg, 120 mg and 160 mg in clinical studies in patients with schizophrenia treated for up to 52 weeks.
Adults: Short-term studies: The following findings are based on the short-term, placebo-controlled studies for schizophrenia in which lurasidone was administered at daily doses ranging from 20 to 160 mg (n=1508).
The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in patients treated with lurasidone were somnolence, akathisia, nausea and parkinsonism.
Adverse reactions associated with the use of lurasidone (incidence of 2% or greater, rounded to the nearest percent and lurasidone incidence greater than placebo) that occurred during acute therapy (up to 6-week in patients with schizophrenia) are shown in Table 3. (See Table 3.)

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Long-term studies: In the long-term studies (≥28 weeks) with lurasidone in adults with schizophrenia (N=768), the most common adverse reactions (≥10%) in patients treated with lurasidone were somnolence, insomnia, akathisia, and nausea.
Other adverse reactions observed during the premarketing evaluation of lurasidone: Following is a list of adverse reactions reported by patients treated with lurasidone at multiple doses of ≥20 mg once daily within the premarketing database of 2905 patients with schizophrenia. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions listed in Table 3 or those that appear elsewhere in the lurasidone label are not included. Although the reactions reported occurred during treatment with lurasidone, they were not necessarily caused by it.
Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).
Blood and lymphatic system disorders: Infrequent: anemia.
Cardiac disorders: Frequent: tachycardia; Infrequent: AV block 1^st degree, angina pectoris, bradycardia.
Ear and labyrinth disorders: Infrequent: vertigo.
Eye disorders: Frequent: blurred vision.
Gastrointestinal disorders: Frequent: abdominal pain, diarrhea; Infrequent: dysphagia, gastritis.
General disorders and administrative site conditions: Rare: sudden death.
Investigations: Frequent: CPK increased.
Metabolism and nutritional system disorders: Frequent: decreased appetite.
Musculoskeletal and connective tissue disorders: Rare: rhabdomyolysis.
Nervous system disorders: Infrequent: cerebrovascular accident, dysarthria.
Psychiatric disorders: Infrequent: abnormal dreams, panic attack, sleep disorder.
Renal and urinary disorders: Infrequent: dysuria; Rare: renal failure.
Reproductive system and breast disorders: Infrequent: amenorrhea, dysmenorrhea; Rare: breast enlargement, breast pain, galactorrhea, erectile dysfunction.
Skin and subcutaneous tissue disorders: Frequent: rash, pruritus; Rare: angioedema.
Vascular disorders: Frequent: hypertension.
Adolescents: Short-term Studies: The following findings are based on the short-term, placebo-controlled premarketing study for schizophrenia in which lurasidone was administered at daily doses ranging from 40 to 120 ng in adolescents ages 13-17 years (n=326).
The most common adverse events reported (incidence 25% and at least twice the rate of placebo) in patients treated with Lurasidone were somnolence, nausea, akathisia, and vomiting.
Adverse events reported with the use of Lurasidone (incidence of 2% or greater, rounded to the nearest percent and Lurasidone incidence greater than placebo) that occurred during acute therapy (up to 6-weeks in adolescent patients with schizophrenia) are shown in Table 4. (See Table 4.)

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Postmarketing experiences: Hypersensitivity (occurring in at least 1/100 patients) and hyponatremia (occurring in 1/100 to 1/1000 patients) have been identified during the post approval use of lurasidone.
Hypersensitivity may include symptoms such as throat swelling, tongue swelling, urticarial, or symptoms of angioedema. Hypersensitivity may also include symptoms of severe cutaneous reactions such as dermatitis bullous, rash maculopapular, skin eruption, and skin exfoliation.