Codeine

 Risk Factor: C*
 Class: RESPIRATORY DRUGS / Antitussives

Contents of this page:

Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers

Fetal Risk Summary

The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 563 of whom had 1st trimester exposure to codeine (1, pp. 287295). No evidence was found to suggest a relationship to large categories of major or minor malformations. Associations were found with six individual defects (1, pp. 287295, 471). Only the association with respiratory malformation is statistically significant. The significance of the other associations is unknown. However, independent confirmation is required for all associations found in this study.

Respiratory (8 cases) Genitourinary (other than hypospadias) (7 cases) Down's syndrome (1 case) Tumors (4 cases) Umbilical hernia (3 cases) Inguinal hernia (12 cases) For use anytime during pregnancy, 2,522 exposures were recorded (1, p. 434). With the same qualifications, possible associations with four individual defects were found (1, p. 484): Hydrocephaly (7 cases) Pyloric stenosis (8 cases) Umbilical hernia (7 cases) Inguinal hernia (51 cases) In an investigation of 1,427 malformed newborns compared to 3,001 controls, 1st trimester use of narcotic analgesics (codeine most common) was associated with inguinal hernias, cardiac and circulatory system defects, cleft lip and palate, dislocated hip and other musculoskeletal defects (2). Second trimester use was associated with alimentary tract defects. In a large retrospective Finnish study, the use of opiates (mainly codeine) during the 1st trimester was associated with an increased risk of cleft lip and palate (3,4). Finally, a survey of 390 infants with congenital heart disease matched with 1,254 normal infants found a higher rate of exposure to several drugs, including codeine, in the offspring with defects (5). Although all four of these studies contain several possible biases that could have affected the results, the data serve as a possible warning that indiscriminate use of codeine may present a risk to the fetus.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 7,640 newborns had been exposed to codeine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 375 (4.9%) major birth defects were observed (325 expected). Specific data were available for six defect categories, including (observed/expected) 74/76 cardiovascular defects, 14/13 oral clefts, 4/4 spina bifida, 25/22 polydactyly, 15/13 limb reduction defects, and 14/18 hypospadias. Only with the total number of defects is there a suggestion of an association between codeine and congenital defects, but other factors, including the mother's disease, concurrent drug use, and chance may be involved.

Use of codeine during labor produces neonatal respiratory depression to the same degree as other narcotic analgesics (6). The first known case of neonatal codeine addiction was described in 1965 (7). The mother had taken analgesic tablets containing 360480 mg of codeine/day for 8 weeks prior to delivery.

A second report described neonatal codeine withdrawal in two infants of nonaddicted mothers (8). The mother of one infant began consuming a codeine cough medication 3 weeks prior to delivery. Approximately 2 weeks before delivery, analgesic tablets with codeine were taken at a frequency of up to six tablets/day (48 mg of codeine/day). The second mother was treated with a codeine cough medication consuming 90120 mg of codeine/day for the last 10 days of pregnancy. Apgar scores of both infants were 810 at 1 and 5 minutes. Typical symptoms of narcotic withdrawal were noted in the infants shortly after birth but not in the mothers.

[* Risk Factor D if used for prolonged periods or in high doses at term.]

Breast Feeding Summary

Codeine passes into breast milk in very small amounts that are probably insignificant (9,10 and 11). The American Academy of Pediatrics considers codeine to be compatible with breast feeding (12).

References

1. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977.
2. Bracken MB, Holford TR. Exposure to prescribed drugs in pregnancy and association with congenital malformations. Obstet Gynecol 1981;58:33644.
3. Saxen I. Associations between oral clefts and drugs taken during pregnancy. Int J Epidemiol 1975; 4;3744.
4. Saxen I. Epidemiology of cleft lip and palate: an attempt to rule out chance correlations. Br J Prev Soc Med 1975;29:10310.
5. Rothman KJ, Fyler DC, Goldblatt A, Kreidberg MB. Exogenous hormones and other drug exposures of children with congenital heart disease. Am J Epidemiol 1979;109:4339.
6. Bonica JJ. Principles and Practice of Obstetric Analgesia and Anesthesia. Philadelphia, PA:FA Davis, 1967:245.
7. Van Leeuwen G, Guthrie R, Stange F. Narcotic withdrawal reaction in a newborn infant due to codeine. Pediatrics 1965;36;6356.
8. Mangurten HH, Benawra R. Neonatal codeine withdrawal in infants of nonaddicted mothers. Pediatrics 1980;65:15960.
9. Kwit NT, Hatcher RA. Excretion of drugs in milk. Am J Dis Child 1935;49:9004.
10. Horning MG, Stillwell WG, Nowlin J, Lertratanangkoon K, Stillwell RN, Hill RM. Identification and quantification of drugs and drug metabolites in human breast milk using GC-MS-COM methods. Mod Probl Paediatr 1975;15:739.
11. Anonymous. Drugs in breast milk. Med Lett Drugs Ther 1974;16:257.
12. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
    
    

Questions and Answers

can you take tylenol with codeine while your are pregnant?

my son's girlfriend is 6 months pregnant and she took tylenol with codeine that her doctor gave her for the flu is this safe for the baby

Definitely not.

I am pregnant and having pain, my doctor perscribed me Oxycodone and Tylonal with Codeine is this safe?

I am 35 weeks pregnant. I have been having lower abdominal pain for 3 weeks now. I was admitted to a University hospital and they can't find any cause for this pain. Since taking the medication my fluid levels have dropped to a 4.3. I am concerned with the effects of these drugs on my body and my babies body. If you have any information please let me know. I am switching doctors today because of poor care at my hospital.

i was in a car accident in my 1st trimester & they (knowing how far along i was) prescribed me vicadin. they know what they're doing. if it makes you uneasy, just try tylenol alone (that's what i did, my pain wasn't very bad after the first day)

i don't know if that helps, but good luck!

4 months pregnant and prescribed Tylenol with codeine?

I went to my primary care doctor this morning and it turns out I have an ulcer on my throat. She prescribed me Tylenol with codeine. I called my OB and they said it was fine to take in the second trimester. I'm still a little concerned as it does contain the narcotic. has anyone ever had problems with this medication in pregnancy or taken it with no problems? Thanks!

Yep, I have taken oxycodone without tylenol my entire pregnancy off and on. I stayed away from it in the first trimester, took it in the 2nd, and I stopped taking it now that I am close to delivering.
Its fine to take, I would not worry about it at all!
Some women are even given morphine in pregnancy with no effects to the baby.
Just don't take more than recommended or it can cause breathing problems with the baby, thats if you are close to delivering though.
Good luck!

i suffer from IBS the diahorria and take codeine sulphate and imodium can i take these while pregnant?

as above i have ibs and tke 6 codeine a day and sometimes 1 imodium after every movement but i go sometimes 6 or 7 times a day so thats 7 or 8 imodium but ive just found out pregnant so can i still takethem

In general, medical studies of IBS during pregnancy recommend conservative treatment, including dietary changes, soluble fiber suplements, exercise, and biofeedback. Pregnancy seems just as likely to affect IBS for the better and not automatically for the worse. Your OB/GYN should be able to address all of your concerns.


Codeine is a category C drug. It can cause harm to the fetus. Research has suggested that there is a correlation between congenital defects and codeine use during pregnancy. i.e. ear, eye, cardiac, hypospadias, etc. Also, the infant becomes "addicted" and goes through "withdrawal" after birth. It is safe to breastfeed while on codeine.

In regards to Imodium sulfate; Imodium A-D has been proven safe for use during pregnancy. Check withyour Dr. on the daily dosing guide.

I am 33 weeks pregnant and my doc perscribed me tylenol with codeine is this safe for me and my baby?

well you are far enough in your pregnancy for certain things and what you can do, is gett a second opinion.

I am 15 weeks pregnant & my family doc prescribed promethazine with codeine as a cough syrup. Is it safe?

Check with your OB or try www.kellymom.com

Taking Codeine whilst pregnant?

Im 13 weeks and got it perscribed by the doctors at the hospital...and they know i am 13 weeks gone. Will it harm my baby if i take it? if so how? And why would i have been given it?
Thanks Danni x

It should be avoided in the third trimester (6-9months).

"Codeine may be used when the benefit is considered to outweigh any risk to the foetus. Codeine is not associated with congenital abnormalities and the risks associated with its use seem to apply mainly to the last three months of pregnancy. If used in the last trimester, codeine may depress the baby's respiration and its regular use during this time may lead to withdrawal effects in the baby after birth. The effects of codeine on the woman's nervous system could also make her more prone to gastric stasis and inhalational pneumonia during labour."

Is it ok that my Dr prescribed me phenergan and tylenol 3 (w/ codeine) while I was pregnant?

If not, why? And why would he give them to me if it weren't okay?

Both Phenergan and Tylenol #3 are pregnancy category C, which means there are either no adequate studies, either animal or human, or there are adverse fetal effects in animal studies but no available human data. Usually, whether or not to prescribe these meds is based on weighing the benefits to the mother against the risks to the unborn child. Was this your OB who prescribed them? If not, ask this doctor to consult your OB about the safety. You can also get a second opinion. Good luck.

Stopped Long Term Use of Codeine, Now Taking Tramadol and 11 weeks pregnant is it really dangerous?

When I was taking the codeine I didn't know I was pregnant and when I did find out I actually stopped the use, but I feel that I am addicted and started taking tramadol. I can't stop it and I'm very depressed if it will be harmful to my baby. In addition to the codeine which I took short term when I first found out I was pregnant, I was taking Ativan since I have anxiety issues before I completely stopped that too. It's the result of a serious automobile accident that almost killed me.

Get into detox. Consider Subutex or Suboxone. Make sure your OB and your pain management docs know your situation.

is it safe for pregnant women to take Codeine?

nope.. its too strong