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Ranitidine Pregnancy and Breastfeeding Warnings

Brand names: Acid Control 150, Acid Control 75, Acid Reducer, Acid Reducer Non-Prescription Strength, Acid Relief, Berkley and Jensen Acid Reducer Maximum Strength, Careone Acid Reducer, Deprizine, Equaline Heartburn Relief, Sunmark Acid Reducer Maximum Strength, Taladine, Zantac

Ranitidine Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Animal models have failed to reveal evidence of impaired fertility or fetal harm. It is unknown whether use of gastric-suppressing drugs are associated with childhood allergy and asthma. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Ranitidine Breastfeeding Warnings

This drug is known to increase prolactin levels. There are no data on galactorrhea and/or adverse effects with breastfeeding.

Caution is recommended.

Excreted into human milk: Yes

See references

See also

References for pregnancy information

  1. Product Information. Zantac (ranitidine). Glaxo Wellcome. 2001;PROD.
  2. Product Information. Zantac 75 (ranitidine). Pfizer U.S. Pharmaceuticals. 2002.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Zantac (ranitidine). Glaxo Wellcome. 2001;PROD.
  2. Product Information. Zantac 75 (ranitidine). Pfizer U.S. Pharmaceuticals. 2002.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.
  5. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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