Strattera

Strattera Adverse Reactions

atomoxetine

Manufacturer:

Eli Lilly

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
Clinical Trial Data: (See Table 1.)

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The following adverse events occurred in at least 2% of child and adolescent CYP2D6 PM patients and were statistically significantly more frequent in PM patients compared with CYP2D6 EM patients: weight decreased (7.3% of PMs, 4.4% of EMs); constipation (6.8% of PMs, 4.3% of EMs); insomnia (11% of PMs, 6.1% of EMs); depression (6.5% of PMs, 4.1% of EMs); tremor (4.5% of PMs, 0.9% of EMs); middle insomnia (2.8% of PMs, 1.3% of EMs); syncope (2.5% of PMs, 0.7% of EMs); conjunctivitis (2.5% of PMs, 1.2% of EMs); early morning awakening (2.3% of PMs, 0.8% of EMs); mydriasis (2.0% of PMs, 0.6% of EMs); sedation (3.9% of PMs, 2.1% of EMs).
Growth: Paediatric patients treated with Strattera in ADHD clinical trials had a mean initial decrease in weight and height gain. Subsequently, over the long-term period, patients recovered to the mean weight and height predicted by group baseline data. (See Table 2.)

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The following adverse events occurred in at least 2% of adult CYP2D6 PM patients and were statistically significantly more frequent in PM patients compared to CYP2D6 EM patients: vision blurred (3.9% of PMs, 1.3% of EMs); dry mouth (34.5% of PMs, 17.4% of EMs); constipation (11.3% of PMs, 6.7% of EMs); feeling jittery (4.9% of PMs, 1.9% of EMs); decreased appetite (23.2% of PMs, 14.7% of EMs); tremor (5.4% of PMs, 1.2% of EMs); insomnia (19.2% of PMs, 11.3% of EMs); sleep disorder (6.9% of PMs, 3.4% of EMs); middle insomnia (5.4% of PMs, 2.7% of EMs); terminal insomnia (3.0% of PMs, 0.9% of EMs); urinary retention (5.9% of PMs, 1.2% of EMs); erectile dysfunction (20.9% of PMs, 8.9% of EMs); ejaculation disorder (6.1% of PMs, 2.2% of EMs); hyperhidrosis (14.8% of PMs, 6.8% of EMs); peripheral coldness (3.0% of PMs, 0.5% of EMs).
Spontaneous Data: (See Table 3.)

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