Cymbalta Adverse Reactions



Eli Lilly


Full Prescribing Info
Adverse Reactions
The most commonly reported adverse reactions in patients treated with Cymbalta were nausea, headache, dry mouth, somnolence, and dizziness. However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
The table as follows gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials.
Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Click on icon to see table/diagram/image

Description of selected adverse reactions: Discontinuation of Cymbalta (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when Cymbalta treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see Dosage & Administration and Precautions).
In the 12 week acute phase of three clinical trials of Cymbalta in patients with diabetic peripheral neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in Cymbalta-treated patients. HbA1c was stable in both Cymbalta-treated and placebo-treated patients. In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the Cymbalta and routine care groups, but the mean increase was 0.3% greater in the Cymbalta-treated group. There was also a small increase in fasting blood glucose and in total cholesterol in Cymbalta-treated patients while those laboratory tests showed a slight decrease in the routine care group.
The heart rate-corrected QT interval in Cymbalta-treated patients did not differ from that seen in placebo-treated patients. No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between Cymbalta-treated and placebo-treated patients.
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