Meloxicam / rizatriptan Pregnancy and Breastfeeding Warnings

Brand names: Symbravo

Medically reviewed by Drugs.com. Last updated on Apr 15, 2025.

Meloxicam / rizatriptan Pregnancy Warnings

Use should be avoided

US FDA pregnancy category: Not assigned

Risk summary (data only available for the individual drug components): Based on its mechanism of action and effects in pregnant patients and animals, meloxicam may cause fetal harm especially when administered at about 20 weeks gestation or later. Insufficient data available on use of rizatriptan in pregnant women to inform a drug-related risk.

Comments:
-At about 20 weeks gestation or later, use the lowest effective dose and shortest duration; consider ultrasound monitoring for oligohydramnios if therapy extends beyond 48 hours and discontinue use if detected.
-At about 30 weeks gestation, use should be avoided due to the potential for premature closure of the fetal ductus arteriosus.
-Inconclusive data available on other potential embryofetal risks associated with use of non-steroidal anti-inflammatory drugs (NSAIDs), such as meloxicam, in the first or second trimesters.
-There are risks to the mother and fetus associated with migraine in pregnancy.
-Male and female fertility may be compromised by this drug.
-Consider treatment discontinuation in women who have difficulties conceiving or who are undergoing investigation of infertility.

MELOXICAM: Animal studies have revealed evidence of embryofetal harm. Administration of meloxicam to pregnant animals during the period of organogenesis resulted in embryolethality and malformations at doses equivalent to 0.5 and up to 59-fold, respectively, the maximum human recommended dose (MRHD). An increased incidence of dystocia, delayed parturition, and decreased offspring survival was reported with meloxicam administration during late gestation and lactation at clinically relevant doses.

There are no controlled data in human pregnancy; however, published studies and postmarketing reports describe fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment with use of NSAIDs at 20 weeks gestation or later. Premature closure of the fetal ductus arteriosus has been reported in the literature with use of NSAIDs after 30 weeks gestation.

Prostaglandin-mediated NSAIDs, such as meloxicam, may adversely affect fertility. In women, NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility. Based on animal studies, meloxicam may compromise fertility in males of reproductive potential.

RIZATRIPTAN: Animal studies have revealed evidence of developmental toxicity. Administration of rizatriptan to pregnant animals at various intervals (e.g., mating, gestation, lactation) resulted in reduced fetal/offspring body weights at doses higher than twice the MRHD. Neonatal mortality and impaired neurobehavioral function were also reported. Placental transfer was demonstrated. There are no controlled data in human pregnancy; however, data from international birth registries suggest that the rate of malformations in women reportedly using triptans during pregnancy was similar to controls.

In women with migraine, there is an increased risk of adverse maternal perinatal outcomes, including pre-eclampsia and gestational hypertension.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Meloxicam / rizatriptan Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Yes (rizatriptan); unknown (meloxicam)
Excreted into animal milk: Yes (meloxicam, rizatriptan)

Comments:
-There are no data available on meloxicam during breastfeeding; according to some experts, other therapies may be preferred, especially while nursing a newborn or preterm infant.
-Breast pain and painful milk ejection have been reported in women who took triptans while nursing.
-The developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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