Table 1.
Category | Definition | Antidepressants by FDA pregnancy-safety category |
---|---|---|
A | Adequate and well-controlled studies in pregnant women have not demonstrated fetal risk with exposure in the first trimester of pregnancy, and there is no evidence of risk with exposure in the second or third trimesters. | None |
B | There are no adequate and well-controlled studies in pregnant women, and animal studies have not shown evidence of fetal risk. | Tetracyclic antidepressants: maprotiline |
C | There are no adequate and well-controlled studies in pregnant women, but animal studies have shown evidence of fetal risk. For pregnant women, potential benefits may warrant use of the medication in pregnant women despite possible risks. | SSRIs: citalopram, escitalopram, fluoxetine, fluvoxamine, sertraline SNRIs: desvenlafaxine, duloxetine, venlafaxine TCAs: amitriptyline, amoxapine, clomipramine, doxepin, trimipramine MAOIs: isocarboxazid, phenelzine, selegiline, tranylcypromine Miscellaneous: bupropion, mirtazapine, nefazodone, trazodone, vilazodone, vortioxetine |
D | There is positive evidence of human fetal risk based on investigational or postmarketing experience, but potential benefits may warrant use of the medication in pregnant women despite possible risks. | SSRIs: paroxetine TCAs: imipramine, nortriptyline |
X | Animal or human studies have shown fetal abnormalities and/or there is positive evidence of human fetal risk based on investigational or postmarketing experience; risks from the medication clearly outweigh potential benefit. | None |
N | The FDA has not classified the medication. | TCAs: desipramine, protriptyline |
Abbreviations: SSRIs, selective serotonin-reuptake inhibitors; SNRIs, serotonin–norepinephrine reuptake inhibitors; TCAs, tricyclic antidepressants; MAOIs, monoamine oxidase inhibitors.