Prozac Adverse Reactions

a. Summary of the safety profile: The most commonly reported adverse reactions in patients treated with fluoxetine were headache, nausea, insomnia, fatigue and diarrhoea. Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
The table as follows gives the adverse reactions observed in clinical trials (n=9297) and from spontaneous reporting.
b. Tabulated list of adverse reactions: The table below gives the adverse reactions observed with fluoxetine treatment in adult and paediatric populations. Some of these adverse reactions are in common with other SSRIs.
The following frequencies have been calculated from clinical trials in adults (n=9297) and from spontaneous reporting.
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). (See table.)

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c. Description of selected adverse reactions: Suicide/suicidal thoughts or clinical worsening: Cases of suicidal ideation and suicidal behavior have been reported during fluoxetine therapy or early after treatment discontinuation (see Precautions).
Bone fractures: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to the risk is unknown.
Withdrawal symptoms seen on discontinuation of fluoxetine treatments: Discontinuation of fluoxetine commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions. Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged (see Precautions). It is therefore advised that when Prozac treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see Dosage & Administration and Precautions).