Is Preparation H (phenylephrine and pramoxine) cream safe to use during pregnancy for hemorrhoids?

Is Preparation H Cream Safe for Pregnancy with Hemorrhoids?

Preparation H cream containing phenylephrine and pramoxine can be used during pregnancy for hemorrhoids, but hydrocortisone-based topical preparations are preferred based on stronger safety evidence. 1, 2

Preferred Treatment Approach

First-Line Management

• Increase dietary fiber to approximately 30 g/day (fruits, vegetables, whole grains, legumes) with adequate fluid intake to soften stools and promote regular bowel movements 1
• Use bulk-forming agents such as psyllium husk or methylcellulose, which are safe due to lack of systemic absorption 1
• Osmotic laxatives including polyethylene glycol or lactulose can be safely administered to prevent constipation that worsens hemorrhoids 1

Topical Hemorrhoid Treatment

• Hydrocortisone foam is the preferred topical agent based on a prospective study of 204 patients treated in the third trimester showing no adverse events compared with placebo 1, 2
• Hydrocortisone-pramoxine combination (Proctofoam-HC) has been specifically studied and found safe in late pregnancy with no adverse effects on birth weight, gestational age, prematurity rates, or pre/postnatal complications 2

Preparation H Cream Considerations

Phenylephrine Component Concerns

• Phenylephrine is a vasoconstrictor that acts on α-adrenergic receptors and can cause systemic absorption leading to cardiovascular effects including elevated blood pressure 3
• The FDA drug label states "Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman" 3
• Oral decongestants (including phenylephrine) should not be used during the first trimester due to conflicting reports of associations with gastroschisis and small intestinal atresia 4

Pramoxine Component

• Pramoxine is a local anesthetic that has demonstrated safety when combined with hydrocortisone in pregnancy studies 2
• The pramoxine component itself is not problematic, but the phenylephrine raises concerns 3, 2

Clinical Algorithm

For pregnant patients with hemorrhoids:

1. Start with non-pharmacologic measures including dietary fiber, adequate hydration, and avoiding straining during bowel movements 1

2. Add bulk-forming agents or osmotic laxatives if constipation persists 1

3. For topical relief, choose hydrocortisone-based preparations (such as hydrocortisone foam or Proctofoam-HC) over phenylephrine-containing products 1, 2

4. If Preparation H cream is already being used, consider switching to hydrocortisone-based alternatives given the stronger safety evidence and absence of vasoconstrictive concerns 1, 2

Important Caveats

• Hemorrhoids occur in approximately 80% of pregnant persons, most commonly during the third trimester due to compression of the rectum by the gravid uterus 1
• Excessive fiber and osmotic laxatives can cause maternal bloating, though this is a tolerability rather than safety concern 1
• Encourage pregnant women to avoid straining by providing ample time for bowel movements, using relaxation techniques, and optimizing diet and hydration 1
• The phenylephrine in Preparation H carries theoretical cardiovascular risks including blood pressure elevation, which is particularly concerning given pregnancy-related hemodynamic changes 3