Medication Safety in Pregnancy & Lactation
Clinician-grade reproductive pharmacology reference. Details trimester-specific teratogenicity, neonatal adaptation syndromes, and lactation compatibility.
Educational & Clinical Reference Only: Does not replace formal clinical consultation or individualized obstetric risk-benefit assessment with the patient's prescribing physician or midwife.
Acetaminophen (Paracetamol)
Common Brands: Tylenol • Indications: Mild-to-moderate pain, Headache, Fever in pregnancy
First-line analgesic and antipyretic in all trimesters of pregnancy. Extensive human cohort data demonstrate no significant increase in major congenital malformations at therapeutic doses (< 3-4 g/day).
- •Earlier observational claims regarding childhood ADHD/autism were definitively refuted by sibling-comparison studies (Ahlqvist et al., JAMA 2024), demonstrating genetic and familial confounding.
- •Untreated maternal fever (>38.5°C) is a proven teratogen causing neural tube defects; treating maternal fever carries profound net benefit.
SOGC and Motherisk: Acetaminophen remains the analgesic and antipyretic of choice in pregnancy when clinically indicated. Use lowest effective dose for shortest duration.
Doxylamine succinate 10mg / Pyridoxine HCl 10mg
Common Brands: Diclectin, Diclegis • Indications: Nausea and vomiting of pregnancy (NVP), Hyperemesis gravidarum (mild-moderate)
First-line pharmacological agent for nausea and vomiting of pregnancy in Canada. Specifically approved by Health Canada for NVP with massive reproductive safety database.
- •No teratogenic risk demonstrated across multiple meta-analyses (>200,000 exposed pregnancies).
- •Delayed-release formulation requires pre-emptive scheduled dosing rather than PRN use.
SOGC Clinical Practice Guideline No. 343: Doxylamine/pyridoxine is the recommended first-line pharmacological treatment for NVP due to proven efficacy and demonstrated fetal safety.
Ondansetron
Common Brands: Zofran • Indications: Severe nausea and vomiting of pregnancy, Hyperemesis gravidarum refractory to first-line agents
Highly effective antiemetic reserved for refractory NVP or hyperemesis. Historical debate regarding oral cleft risk has been largely resolved by recent large cohort studies showing baseline absolute risk remains extremely low.
- •Early observational data suggested a slight absolute increase in cleft palate (~3 additional cases per 10,000 treated pregnancies).
- •Subsequent massive Medicaid cohort (Huybrechts et al., JAMA 2018) showed no association with cardiac malformations and only borderline cleft association. Net risk-benefit strongly favors use in dehydrated, malnourished patients.
SOGC Guidelines recommend ondansetron as a second/third-line option when first-line combination therapy fails to prevent dehydration or weight loss.
Ibuprofen
Common Brands: Advil, Motrin • Indications: Inflammatory pain, Postpartum analgesia
Contraindicated at >= 20 weeks gestation, and strictly contraindicated in the third trimester (>= 28 weeks). Compatible and preferred postpartum during lactation.
- •Premature closure or constriction of the fetal ductus arteriosus, resulting in fetal pulmonary hypertension.
- •Fetal renal impairment leading to oligohydramnios (reduced amniotic fluid) as early as 20 weeks gestation (Health Canada / FDA Black Box warning).
- •Prolongation of pregnancy and impaired platelet aggregation.
Avoid all NSAIDs from 20 weeks gestation onward. In the postpartum period, ibuprofen is the drug of choice for uterine cramping pain and perineal discomfort due to minimal breast milk excretion.
Sertraline
Common Brands: Zoloft • Indications: Major depressive disorder, Generalized anxiety disorder, Obsessive-compulsive disorder
Preferred first-line SSRI in pregnancy and lactation. Untreated maternal depression and anxiety carry established risks (poor nutrition, cortisol dysregulation, preterm birth, postpartum depression).
- •No evidence of major teratogenesis.
- •Poor Neonatal Adaptation Syndrome (PNAS) in ~15-30% of neonates exposed in late 3rd trimester: mild transient jitteriness, tachypnea, weak cry; self-limiting within 48-72 hours.
- •Persistent Pulmonary Hypertension of the Newborn (PPHN): small absolute risk increase from ~1-2 per 1000 to ~3 per 1000 births.
SOGC & CANMAT Guidelines: Do not abruptly discontinue antidepressants upon pregnancy discovery. Sertraline and citalopram are preferred due to extensive safety data and low breast milk transfer.
Labetalol
Common Brands: Trandate • Indications: Chronic hypertension in pregnancy, Gestational hypertension, Preeclampsia
First-line antihypertensive agent of choice throughout pregnancy. Reduces maternal cardiovascular complications without causing uterine hypoperfusion.
- •Potential mild neonatal bradycardia or hypoglycemia; monitor neonate for 24-48 hours.
- •Does not cause the fetal renal dysgenesis seen with ACE inhibitors or ARBs.
SOGC Hypertensive Disorders of Pregnancy Guideline: Labetalol, oral nifedipine XL, and methyldopa are the primary recommended agents to maintain BP 130-135/80-85 mmHg.
Low-Dose Acetylsalicylic Acid (Aspirin 162 mg)
Common Brands: Aspirin 81mg (x2) • Indications: Preeclampsia prophylaxis in high-risk pregnancies, Fetal growth restriction prevention
Standard of care for preeclampsia prophylaxis in women with moderate-to-high risk criteria. Begun between 12 and 16 weeks gestation, taken nightly at bedtime, continued until 36-37 weeks.
- •Unlike full-dose NSAIDs, low-dose ASA (81-162 mg) does not cause premature ductus arteriosus closure or oligohydramnios.
- •Significantly reduces preterm preeclampsia by up to 62% in high-risk women (ASPRE trial).
SOGC Guideline No. 426: Low-dose ASA (81–162 mg daily, ideally 162 mg taken at bedtime) should be initiated before 16 weeks gestation for women with high-risk clinical factors.
Amoxicillin / Amoxicillin-Clavulanate
Common Brands: Amoxil, Clavulin • Indications: Asymptomatic bacteriuria, Acute cystitis, Respiratory tract infections, Streptococcal pharyngitis
Safe and widely used antibiotic class in all trimesters. Penetrates bacterial cell wall without human teratogenicity.
- •Extensive human surveillance indicates no increased risk of major birth defects.
- •Untreated maternal asymptomatic bacteriuria carries ~20-30% progression to maternal pyelonephritis, sepsis, and preterm birth.
SOGC & Health Canada: Amoxicillin and cephalosporins are first-line for bacterial infections in pregnancy.
Nifedipine Extended Release
Common Brands: Adalat XL • Indications: Preeclampsia & Gestational Hypertension, Acute severe hypertension (rapid acting), Tocolysis in preterm labour (24-34w)
First-line oral antihypertensive for urgent blood pressure control and maintenance in pregnancy. Extensive registry data confirm no teratogenicity.
- •Avoid sublingual immediate-release capsule punctures due to risk of precipitous maternal hypotension and sudden uteroplacental hypoperfusion.
SOGC Guideline No. 426: Nifedipine extended release (20-60mg PO daily) or immediate release tablet (10-20mg PO swallowed whole) is first-line for non-severe and acute severe hypertension in pregnancy.
Methyldopa
Common Brands: Aldomet • Indications: Chronic hypertension in pregnancy, Mild-to-moderate gestational hypertension
Longest pediatric safety track record of any obstetric antihypertensive with child neurodevelopmental follow-up to age 7. Mild potency and maternal sedation/depression are limiting factors.
- •No fetal teratogenicity; extensive multi-decade safety data.
SOGC Guideline No. 426: Acceptable first-line agent for chronic hypertension in pregnancy, particularly when initiating therapy preconception.
Magnesium Sulfate
Common Brands: MgSO4 • Indications: Eclampsia seizure prophylaxis in severe preeclampsia, Fetal neuroprotection in imminent preterm birth (<32 weeks)
Drug of choice for prevention and treatment of eclamptic seizures (superior to phenytoin and diazepam). Significantly reduces cerebral palsy risk in infants born before 32 weeks.
- •Transient decreased fetal heart rate variability and hypotonia at birth.
- •Prolonged infusions (>5-7 days) associated with fetal bone demineralization, but short-term (24h) protocol is extremely safe.
SOGC Guidelines No. 426 & 376: 4g IV loading dose over 20-30 min followed by 1g/h maintenance infusion for 24h postpartum or until 24h post-delivery.
Hydralazine
Common Brands: Apresoline • Indications: Acute severe hypertension in pregnancy (SBP >= 160 or DBP >= 110 mmHg)
Parenteral vasodilator for rapid reduction of acute dangerous hypertensive crisis in labour & delivery triage. Administer 5-10mg IV push slowly q20-30min (max 20mg).
- •Maternal reflex tachycardia and excessive hypotension can cause fetal heart rate decelerations.
SOGC Guideline No. 426: Recommended parenteral option for emergent control of severe obstetric hypertension alongside IV labetalol.
Oxytocin
Common Brands: Syntocinon, Pitocin • Indications: Active management of 3rd stage of labour (PPH prevention), Treatment of uterine atony PPH, Induction and augmentation of labour
Gold standard first-line uterotonic for both prevention and treatment of postpartum hemorrhage. Stimulates rhythmic myometrial contractions.
- •During labour: uterine tachysystole, hypertonus, and fetal distress if titrated too rapidly.
- •Antidiuretic (vasopressin-like) effect: high-volume infusions in electrolyte-free water can cause maternal hyponatremia and water intoxication.
SOGC Guideline No. 235: Routine administration of 10 IU IM or IV slow infusion immediately after delivery of anterior shoulder or complete delivery of infant reduces PPH by 50%.
Misoprostol
Common Brands: Cytotec • Indications: Postpartum hemorrhage treatment (600-800 mcg sublingual/rectal), Medical management of early pregnancy loss, Cervical ripening (strictly contraindicated in TOLAC/VBAC)
Potent uterotonic and cervical priming agent. Heat-stable, making it vital for resource-constrained settings. First-trimester exposure causes Mobius syndrome and terminal transverse limb defects.
- •1st trimester teratogen: cranial nerve VI/VII palsy (Mobius syndrome), equinovarus, and limb anomalies.
- •In labour with scarred uterus: catastrophic uterine scar rupture.
SOGC Guideline No. 235: 400-800 mcg sublingual or buccal misoprostol is effective second-line uterotonic for PPH refractory to oxytocin.
Carboprost Tromethamine
Common Brands: Hemabate • Indications: Severe postpartum hemorrhage refractory to oxytocin and ergometrine
Parenteral second-line uterotonic administered 250 mcg IM or intramyometrially q15-90min (max 8 doses). High efficacy in refractory uterine atony. Causes intense bronchoconstriction—STRICTLY CONTRAINDICATED IN ASTHMA.
- •Used postpartum; no direct fetal risk. Causes severe maternal diarrhea, vomiting, fever, and bronchospasm.
SOGC Guideline No. 235: Second-line uterotonic of choice for refractory uterine atony, provided maternal reactive airway disease / asthma is excluded.
Ergometrine Maleate
Common Brands: Ergonovine • Indications: Postpartum hemorrhage secondary to uterine atony
Produces sustained, tetanic uterine smooth muscle contraction and peripheral arterial vasoconstriction. Administer 0.2mg IM. STRICTLY CONTRAINDICATED IN HYPERTENSION, PREECLAMPSIA, AND CORONARY ARTERY DISEASE.
- •Postpartum administration; severe maternal hypertension, cerebral hemorrhage, and coronary vasospasm if given to preeclamptic patients.
SOGC Guideline No. 235: Effective second-line uterotonic for normotensive women with postpartum atony.
Betamethasone
Common Brands: Celestone Soluspan • Indications: Fetal lung maturation and intraventricular hemorrhage prevention in threatened preterm birth (24+0 to 34+6 weeks)
Readily crosses placenta due to poor inactivation by 11-beta-HSD2. Stimulates type II pneumocyte synthesis of pulmonary surfactant. Administer 12mg IM q24h for 2 doses.
- •Transient suppression of fetal breathing movements and heart rate variability (normal and expected for 48-72h post-injection).
- •Substantially reduces neonatal mortality, RDS, and IVH by ~50%.
SOGC Guideline No. 364: A single course of antenatal corticosteroids is strongly recommended for all pregnant individuals between 24+0 and 34+6 weeks at high risk of preterm delivery within 7 days.
Dalteparin Sodium
Common Brands: Fragmin • Indications: Antenatal and postpartum VTE prophylaxis and therapeutic treatment of DVT/PE, Mechanical heart valves, Antiphospholipid antibody syndrome (with ASA)
Anticoagulant of choice in pregnancy. High molecular weight prevents placental crossing; completely safe for fetus. Negligible risk of heparin-induced thrombocytopenia (HIT) compared to unfractionated heparin.
- •Does not cross placenta; zero teratogenic or fetal bleeding risk.
- •Critical maternal consideration: withhold for 12h (prophylactic) or 24h (therapeutic) prior to epidural or spinal anesthesia.
SOGC Guideline No. 308: LMWH is the preferred anticoagulant in pregnancy for both prevention and treatment of venous thromboembolism.
Human & Analogue Insulin (Lispro, Aspart, NPH, Detemir, Glargine)
Common Brands: Humalog, NovoRapid, Humulin N, Levemir, Lantus • Indications: Gestational diabetes mellitus (GDM) failing dietary targets, Pre-existing Type 1 or Type 2 Diabetes in pregnancy
Gold standard pharmacological treatment for maternal hyperglycemia. Does not cross the placenta in clinically significant amounts, while effectively eliminating fetal hyperinsulinemia, macrosomia, and neonatal hypoglycemia.
- •Maternal hypoglycemia. Fetal macrosomia and polyhydramnios result from maternal HYPERglycemia, not insulin therapy.
Diabetes Canada & SOGC: Insulin is the first-line medication of choice when lifestyle and nutritional therapy fail to achieve glycemic targets in pregnancy.
Metformin Hydrochloride
Common Brands: Glucophage • Indications: Gestational diabetes mellitus (when insulin refused or infeasible), Polycystic ovary syndrome (PCOS) ovulation induction
Crosses the placenta freely with umbilical cord levels equal to maternal circulation. Extensive RCT data show no increase in congenital anomalies, though long-term child adiposity follow-up studies suggest slightly higher BMI at age 9 compared to insulin offspring.
- •Readily crosses placenta; no structural teratogenicity demonstrated in large trials.
Diabetes Canada: Metformin may be considered second-line in women with GDM who decline or cannot safely administer insulin.
Ursodeoxycholic Acid (UDCA)
Common Brands: Actigall, Urso • Indications: Intrahepatic cholestasis of pregnancy (ICP)
First-line pharmacotherapy for Intrahepatic Cholestasis of Pregnancy. Displaces hydrophobic hepatotoxic bile acids, enhances biliary clearance, and relieves pruritus in 60-70% of patients. Dose: 10-15 mg/kg/day divided BID or TID.
- •Safe throughout pregnancy; reduces transplacental transfer of bile acids to fetus.
SOGC Guideline No. 423: Ursodeoxycholic acid is the first-line drug for maternal symptom improvement and reduction of serum bile acid levels in ICP.
Cefazolin Sodium
Common Brands: Ancef • Indications: Surgical site infection prophylaxis prior to Cesarean section, Group B Streptococcus (GBS) intrapartum prophylaxis in penicillin allergy (low anaphylaxis risk)
Bactericidal beta-lactam covering methicillin-susceptible staphylococci and streptococci. Dose: 2g IV (3g if weight > 120 kg) administered 15-60 min prior to surgical incision.
- •Wide safety margin; no teratogenic or fetotoxic effects identified across decades of clinical use.
SOGC Guideline No. 427: Single-dose IV cefazolin within 60 minutes prior to incision is mandatory standard of care for all cesarean deliveries.
Ampicillin Sodium
Common Brands: Ampicin • Indications: Intra-amniotic infection / Chorioamnionitis (with Gentamicin), Preterm pre-labour rupture of membranes (PPROM) latency protocol, Listeria monocytogenes in pregnancy
Broad-spectrum aminopenicillin with excellent transplacental penetration into amniotic fluid. First-line for maternal Listeria bacteremia and neonatal early-onset sepsis empiric coverage.
- •Non-teratogenic; excellent human safety record.
SOGC Guidelines: Standard component of 7-day latency antibiotic regimen in PPROM and intrapartum chorioamnionitis triple therapy.
Gentamicin Sulfate
Common Brands: Garamycin • Indications: Chorioamnionitis / Intra-amniotic infection (with Ampicillin), Post-cesarean endometritis (with Clindamycin/Ampicillin), Empiric neonatal sepsis (with Ampicillin)
Bactericidal against gram-negative aerobes (E. coli, Klebsiella). Once-daily dosing (4.5-5 mg/kg IV q24h) achieves superior peak bactericidal action with low maternal-fetal nephrotoxicity.
- •Theoretical fetal ototoxicity and nephrotoxicity with prolonged maternal regimens, but brief intrapartum or neonatal courses show excellent safety profiles.
SOGC Guideline No. 396: Ampicillin + Gentamicin is the recommended first-line regimen for intrapartum fever / chorioamnionitis.
Ceftriaxone Sodium
Common Brands: Rocephin • Indications: Acute maternal pyelonephritis, Neisseria gonorrhoeae in pregnancy, Severe sepsis of unknown source
Broad-spectrum parenteral cephalosporin with once-daily dosing (1-2g IV/IM). Highly effective for acute maternal pyelonephritis. Caution in hyperbilirubinemic neonates as it displaces bilirubin from albumin.
- •Non-teratogenic; excellent pregnancy safety profile.
SOGC Pyelonephritis Guidelines: First-line inpatient IV antibiotic for acute antepartum pyelonephritis until afebrile for 48 hours.
Tranexamic Acid (TXA)
Common Brands: Cyklokapron • Indications: Postpartum hemorrhage (PPH) treatment within 3 hours of birth
Synthetic lysine analogue that competitively inhibits plasminogen activation. The landmark WOMAN Trial (Lancet 2017) demonstrated a 31% reduction in maternal death from bleeding when given within 3 hours of birth. Dose: 1g IV over 10 min, repeatable once after 30 min if bleeding continues.
- •Administered postpartum; no direct fetal exposure.
- •Does not increase maternal thromboembolic events when given for acute PPH.
SOGC & WHO: Tranexamic acid 1g IV should be administered early (within 3 hours of delivery) to all women diagnosed with clinically significant postpartum hemorrhage.
Nitrofurantoin
Common Brands: Macrobid, Macrodantin • Indications: Asymptomatic bacteriuria in pregnancy, Acute uncomplicated cystitis
First-line oral agent for lower urinary tract infections in pregnancy with concentrated urine excretion and negligible systemic absorption. Avoid in term labour (>=37w) and G6PD deficiency due to theoretical neonatal hemolysis risk.
- •Avoid at term (>=37 weeks) due to theoretical risk of neonatal hemolytic anemia from immature glutathione enzyme pathways.
SOGC Urinary Tract Infection Guidelines: Nitrofurantoin 100mg PO BID x 5-7 days is first-line for asymptomatic bacteriuria and acute cystitis in the first and second trimesters.