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Table 1
Clinical Trial Incidence Rates of Fluoxetine Undesirable Effects
All US IND Placebo-Controlled Clinical Trials
Fluoxetine N = 4,397; Placebo N = 2,918
| Body system/Undesirable Effects |
Fluoxetine Incidence % |
Placebo Incidence % |
| Body as a Whole |
|
|
| Anaphylactoid reaction |
0.02 |
NA |
| Asthenia |
17.9 |
10.9 |
| Chills |
2.2 |
1.0 |
| Dry Mouth |
8.6 |
5.1 |
| Photosensitivity |
0.05 |
0.03 |
| Pruritis |
3.5 |
2.4 |
| Rash |
4.8 |
4.3 |
| Serum sickness-like reaction |
0.02 |
NA |
| Sweating |
9.9 |
3.6 |
| Urticaria |
1.6 |
0.8 |
| Vasculitis |
0.02 |
NA |
| Vasodilatation |
2.9 |
1.7 |
| Digestive System |
|
|
| Diarrhoea |
14.1 |
9.6 |
| Dyspepsia |
8.7 |
5.7 |
| Dysphagia |
0.9 |
0.3 |
| Nausea |
22.4 |
10.6 |
| Taste Perversion |
1.6 |
0.8 |
| Vomiting |
3.3 |
2.4 |
| Haemic and Lymphatic System |
|
|
| Ecchymosis |
0.6 |
0.2 |
| Nervous System |
|
|
| Abnormal dreams |
2.1 |
1.4 |
| Anorexia |
9.9 |
3.1 |
| Anxiety |
12.9 |
10.9 |
| Ataxia |
0.2 |
NA |
| Buccoglossal syndrome |
0.25 |
0.03 |
| Concentration impaired/Thought process Impaired |
4.5 |
3.0 |
| Depersonalization |
0.6 |
0.1 |
| Dizziness |
10.3 |
7.6 |
| Insomnia |
20.2 |
11.8 |
| Manic reaction |
0.11 |
0.03 |
| Myoclonus |
0.3 |
NA |
| Nervousness |
14.8 |
10.1 |
| Psychomotor restlessness |
0.2 |
NA |
| Somnolence |
15.2 |
6.2 |
| Tremor |
11.1 |
2.2 |
| Twitching |
0.9 |
0.5 |
| Palpitation |
2.3 |
1.5 |
| Weight Loss |
1.6 |
0.7 |
| Respiratory |
|
|
| Yawn |
4.4 |
0.2 |
| Skin and Appendages |
|
|
| Alopecia |
0.4 |
0.3 |
| Special Senses |
|
|
| Blurred vision |
2.1 |
1.1 |
| Mydriasis |
0.45 |
0.03 |
| Urogenital System |
|
|
| Anorgasmia |
0.2 |
NA |
| Delayed or absent ejaculation |
2.0 |
0.2 |
| Impotence* |
2.9 |
0.6 |
| Libido decreased |
4.4 |
0.4 |
| Priapism/Prolonged erection* |
0.1 |
0.1 |
| Urinary frequency |
1.8 |
1.0 |
| Urination impaired |
0.41 |
0.03 |
NA = Not Applicable, i.e. no cases in this database
*Incidence based on males only; fluoxetine N=1,472; placebo N=942. |
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