Treatment class |
Agent/intervention |
Purpose |
Summary of knowledge in managing FD during pregnancy |
WHO/CDC/FDA/ACOG safety in pregnancy |
WHO/CDC/FDA/ACOG/HALE safety in breastfeeding |
Diet |
Glycaemic control |
Minimise gastric emptying disturbances |
Prevent worsening gastric motor function, and other complications of gestational diabetes. Consider referral to an obstetric dietician |
ACOG: Gestational diabetes should be treated with nutrition therapy. If necessary, medications should also be used to benefit the mother and foetus |
ACOG: Women with positive screening results should be referred for preventive therapy |
Low FODMAP diet |
Minimise and identify symptom triggers |
If considered, work with an obstetric dietician to ensure macro- and micronutrient demands of pregnancy and lactation are met. Not currently recommended in pregnancy by Monash University FODMAP diet creators. May be more effective in those with epigastric bloating |
No recommendation |
No recommendation |
Avoid trigger foods, high-fat diets, wheat/gluten, spicy-diets or other specific restrictive diets |
Minimise and identify symptom triggers |
If considered, work with an obstetric dietician to ensure macro- and micronutrient demands of pregnancy and lactation are met. Ensure there is no component of restrictive or other eating disorder |
No recommendation |
No recommendation |
Minimise carbonated beverages, consume smaller and more frequent meals |
Minimise gastric distension |
Will also help treat concomitant gastro-oesophageal reflux symptoms |
No recommendation |
No recommendation |
Antimicrobial |
Metronidazole |
Treat H. pylori |
Asymptomatic/minimally symptomatic should be treated after pregnancy and cessation of lactation. Consider PPI + clarithromycin + metronidazole ± amoxicillin. Do not give with bismuth |
FDA: Class B CDC: Can be given at any stage of pregnancy. Low risk |
CDC: Breastfeeding should be withheld 12–24 h after a dose or use a lower maternal dose HALE: L2 (probably compatible) |
Amoxicillin |
Asymptomatic/minimally symptomatic should be treated after pregnancy and cessation of lactation. Consider PPI + clarithromycin + metronidazole ± amoxicillin. One retrospective cohort study found that clarithromycin and amoxicillin was effective in H. pylori eradication to treat hyperemesis gravidarum without observed impact of foetal growth |
FDA: Class B |
WHO: safe when used in usual recommended doses HALE: L1 (compatible) |
Clarithromycin |
Asymptomatic/minimally symptomatic should be treated after pregnancy and cessation of lactation. Consider PPI + clarithromycin + metronidazole ± amoxicillin. One retrospective cohort study found that clarithromycin and amoxicillin were effective in H. pylori eradication to treat hyperemesis gravidarum without observed impact of foetal growth |
FDA: Class C |
WHO: No official stance. Monitor infants for GI disturbances HALE: L3 (probably compatible) |
Levofloxacin |
No/minimal data |
FDA: Class C. CDC: Possible animal data of foetal cartilage damage; Levofloxacin is approved in pregnant patients for illnesses that may threaten foetal viability or development and result in serious adverse maternal outcomes |
WHO: Avoid if alternative agents are available HALE: L2 (probably compatible) |
Tetracycline/doxycycline |
Do not give with bismuth |
FDA: Class D CDC: Contraindicated in 2nd and 3rd trimester |
WHO: Use alternative medications when possible HALE: L3 (probably compatible) |
Rifabutin |
No/minimal data |
FDA: Class C |
No recommendation |
Tinidazole |
No/minimal data |
CDC: Avoid during pregnancy FDA: Class C |
HALE: L3 (probably compatible) |
Nitazoxanide |
No/minimal data |
No recommendation |
HALE: L3 (probably compatible) |
Acid suppression |
Proton pump inhibitors |
Suppress acid, H. pylori eradication |
One systematic review found possible increased outcome of malformations but had significant methodological limitations. Most other studies have found no concern. Lansoprazole was used in the retrospective cohort study for H. pylori eradication to treat hyperemesis gravidarum without observed impact of foetal growth |
FDA: Class B except omeprazole which is class C |
HALE: L2 (probably compatible) except pantoprazole which is L1 (compatible) and rabeprazole is L3 (probably compatible) |
Histamine-2 blockers |
Suppress acid |
One systematic review found no increased risk of malformations or abortion, but found possible increased outcome of preterm birth. Most other studies have found no concern |
FDA: Class B |
HALE: Famotidine is L2 (probably compatible) and Cimetidine is L1 (compatible) |
Antacid |
Suppress acid |
Used in management of heartburn and acid reflux. Has not been found to be effective in the treatment of FD |
No recommendation |
WHO: aluminium hydroxide is considered compatible with breastfeeding when used in usual recommended doses. HALE: Only magnesium hydroxide is L1 (compatible). Other formulations are L2 or L3 (probably compatible) |
Alginates |
Suppress acid |
Used in the management of heartburn and acid reflux. Has not been found to be effective in the treatment of FD |
No recommendation |
No recommendation |
Sucralfate |
Suppress acid |
Used in the management of heartburn and acid reflux. Has not been found to be effective in the treatment of FD |
FDA: Class B |
HALE: L1 (compatible) |
Bismuth salicylate |
H. pylori eradication |
Salicylate content prevents safe use in pregnancy and lactation. Monotherapy has not been found to be effective in the treatment of FD |
FDA: Class D |
HALE: L3 (probably compatible) |
Neuromodulator |
Mirtazapine |
Modulate peripheral hypersensitivity and treat depression |
Consider treatment based on ACOG guidelines on treatment of depression during pregnancy when benefit of therapy outweighs the risk |
FDA: Class C ACOG: Therapy with antidepressants during pregnancy should be individualised |
HALE + ACOG: L3 (probably compatible) |
Tricyclic antidepressants |
Modulate peripheral hypersensitivity and treat anxiety and depression |
Avoid doxepin. May cause increased risk for pre-term delivery and perinatal complications during third-trimester use. Consider treatment based on extrapolating ACOG guidelines on treatment of depression during pregnancy when benefit of therapy outweighs the risk |
FDA: Class C except maprotiline which is class B ACOG: Therapy with antidepressants during pregnancy should be individualised |
HALE + ACOG: L2-L3 (probably compatible) |
Selective serotonin re-uptake inhibitor |
Modulate peripheral hypersensitivity and treat anxiety and depression |
Has not been found to be effective in the treatment of FD |
FDA: Class C except paroxetine which is class D |
HALE + ACOG: L2-L3 (probably compatible) |
Serotonin and norepinephrine re-uptake inhibitor |
Modulate peripheral hypersensitivity and treat anxiety and depression |
Has not been found to be effective in the treatment of FD |
FDA: Class C |
HALE + ACOG: L3 except venlafaxine which is L2 (probably compatible) |
Prokinetic |
Erythromycin |
Increase gastric emptying and accommodation |
Used to treat preterm prelabour rupture of membranes in pregnancy. Long-term treatment risks tachyphylaxis |
FDA: Class B |
WHO: Should be safe during breastfeeding at regular doses HALE: L3 (probably compatible) |
Metoclopramide |
Increase gastric emptying and accommodation |
Used in NVP as an adjunctive therapy for persistent symptoms. Contraindicated with cardiac history |
FDA: Class B. ACOG: Can be given oral or IV depending on hydration status in NVP |
WHO: Avoid due to insufficient data on long-term side effects to the infant HALE: L2 (probably compatible) |
Domperidone |
Increase gastric emptying and accommodation |
Contraindicated in cardiac history. Not approved in the USA except for expanded use |
FDA: expanded access use only |
FDA: not be used off label to increase milk production due to cardiac safety concerns HALE: L3 (probably compatible) |
Buspirone/tandospirone |
Increase gastric accommodation |
No studies in FD with pregnancy. May improve PDS symptoms. Not well-validated in FD |
FDA: Class B |
HALE: L3 (probably compatible) |
Sulpiride or levosulpiride |
Increase gastric accommodation |
Very poor-quality efficacy and safety data at this time |
FDA: Not approved |
HALE: L3 (probably compatible) |
Acotiamide/itopride |
Increase gastric emptying and accommodation |
Not approved in the USA, no safety studies in pregnancy |
FDA: Not approved |
Unknown |
Cisapride, tegaserod |
Increase gastric emptying and accommodation |
Voluntarily withdrawn |
FDA: Withdrawn |
FDA: Withdrawn HALE: L4 (probably hazardous) |
Other pharmacologics |
Rifaximin |
Treat gut dysbiosis |
Teratogenic in rats and rabbits, derived from a teratogen |
No recommendation |
HALE: L3 (probably compatible) |
Probiotics |
Treat gut dysbiosis |
No adverse events during pregnancy or breastfeeding except for possible increased pre-eclampsia risk in patients at risk for gestational diabetes |
No recommendation |
HALE: L3 (probably compatible) |
Herbal therapies |
Peppermint and caraway oil |
Increase gastric emptying, alter gut sensitivity |
May cause or exacerbate reflux during pregnancy. Peppermint oil without teratogenic effects and no adverse effects during breastfeeding. Caraway oil unknown safety during pregnancy. No adverse effects in two small studies during breastfeeding |
ACOG: Peppermint oil can be used for IBS with recommended enteric formulation |
No recommendation |
Ginger |
Possibly increase gastric emptying rates |
No adverse events during pregnancy in one systematic review |
ACOG: First line in NVP |
HALE: L3 (probably compatible) |
Topical mastic oil |
Unknown |
Only one randomised controlled trial examining FD in pregnancy. Was effective against early satiation |
No recommendation |
No recommendation |
Rikkunshito |
Increase gastric emptying and accommodation |
Contains herbs associated with adverse foetal effects in animal studies |
No recommendation |
No recommendation |
Artichoke extract |
Ameliorates bile dyskinesia |
Less weight gain in foetal rats when given at commercial extract doses. No breastfeeding studies |
No recommendation |
No recommendation |
Iberogast |
Increase gastric accommodation |
Contains alcohol and herbs associated with adverse foetal effects on epidemiological and animal studies |
No recommendation |
No recommendation |
Zhizhu Kuanzhong |
Increase gastric emptying, alter gut sensitivity |
Several herbs associated with foetal adverse effects in animal studies. Sympathomimetic concerns |
No recommendation |
No recommendation |
Nonpharmacological therapies |
Psychotherapy |
Improve coping skills, treat comorbid anxiety and depression |
Well-established in perinatal and postpartum depression with minimal to no adverse effects. Can help treat comorbid or driving eating disorders |
No recommendation |
No recommendation |
Acupuncture |
Decrease visceral hypersensitivity through autonomic pathways |
Safe when used appropriately with correct training in functional dyspepsia. Has been used safely to manage pain during breastfeeding and during pregnancy |
ACOG: First line in NVP |
No recommendation |
Electrical stimulation |
Decrease visceral hypersensitivity through autonomic pathways |
Not studied in functional dyspepsia. Used effectively in chronic abdominal pain due to other functional aetiologies. Safely used during breastfeeding for uterine contraction pain |
No recommendation |
No recommendation |
Virtual reality |
Unknown mechanism, possibly by alleviating comorbid anxiety and depression |
Only one randomised controlled trial. Virtual reality has been safe in managing anxiety and pain during pregnancy |
No recommendation |
No recommendation |