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Cialis (Tadalafil) Pregnancy & Lactation Safety

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At a glance

  • Cialis in females / Not indicated; the label has no pregnancy data [1]
  • Tadalafil in human milk / The label has no information on its presence [1]
  • FDA pregnancy letters / Removed by the 2015 labeling rule [4]
  • Human pregnancy data in PAH / One 18-patient series; tadalafil not named in its abstract [3]
  • Cialis indications / ED, BPH, ED with BPH [1]
  • Adcirca indication / PAH [2]
  • Drug in semen / Less than 0.0005% of a dose [1]

What the Cialis label says

The Cialis label states that Cialis is not indicated for use in females [1]. For pregnancy, it says there are no data on the use of Cialis in pregnant women to inform any drug-associated risks. For breastfeeding, it says there is no information on the presence of tadalafil or its metabolites in human milk [1].

Does tadalafil have a pregnancy category?

No. The FDA's Pregnancy and Lactation Labeling Rule removed the A, B, C, D and X categories and took effect on June 30, 2015 [4]. Labeling for prescription drugs approved on or after June 30, 2001 is being converted gradually under that rule [4]. Cialis was approved in November 2003 [5].

Pregnancy in PAH, the Adcirca indication

A retrospective review of 18 pregnant patients with PAH at five US centers between 1999 and 2009 found that six underwent pregnancy termination and 12 continued pregnancy; all 12 delivered by cesarean section at 34 weeks [3]. Nine of the 12 received PAH-specific therapy at delivery, described in the abstract as sildenafil, intravenous prostanoids, or combination therapy; the abstract does not mention tadalafil [3]. There was one in-hospital death and one death two months postpartum, a maternal mortality of 16.7%, and the authors concluded that patients should continue to be counseled to avoid pregnancy [3]. These figures describe PAH in pregnancy, not the effect of tadalafil.

A male partner taking Cialis

Cialis is labeled for ED and BPH [1]. The Cialis label states that less than 0.0005% of a dose appears in semen [1].

Frequently asked questions

Is Cialis safe during pregnancy?
Cialis is not indicated for use in females, and the label says there are no data on its use in pregnant women to inform any drug-associated risks [1].
Does tadalafil pass into breast milk?
The Cialis label says there is no information on the presence of tadalafil or its metabolites in human milk [1].
Does tadalafil cause birth defects?
The Cialis label has no pregnancy data to inform drug-associated risks [1]. The 18-patient PAH pregnancy series names sildenafil and intravenous prostanoids as the PAH therapy in its abstract, not tadalafil, so it cannot answer this [3].
What pregnancy category is Cialis?
There is none. The A to X categories were removed by the FDA labeling rule that took effect on June 30, 2015 [4]. Cialis, approved in November 2003, falls within the group of drugs covered by the gradual transition [5][4].
Does tadalafil get into semen?
The Cialis label states that less than 0.0005% of a dose appears in semen [1].

References

  1. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Duarte AG, Thomas S, Safdar Z, Torres F, Pacheco LD, Feldman J, et al. Management of pulmonary arterial hypertension during pregnancy: a retrospective, multicenter experience. Chest. 2013;143(5):1330-1336. Management of pulmonary arterial hypertension during pregnancy: a retrospective, multicenter experience
  4. Pregnancy and Lactation Labeling Resources | FDA. Pregnancy and Lactation Labeling Resources | FDA
  5. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
Evidence overview for Cialis (Tadalafil) Pregnancy & Lactation Safety