Major side effects
Minor side effects
Increased incidence of CVS
diseases, viz venous thromboembolism, heart attack
including ischaemic heart disease, cerebrovascular
disease or stroke and hypertension.
Break through bleeding, amenorrhoea
Weak association between long term
use of OC and breast cancer diagnosed before the age of
Breast tenderness or fullness
Reduced glucose tolerance
Clotting disorders, Pulmonary
Abnormal thyroid and adrenal
Changes in lipid and lipoprotein
Less commonly, dermatologic
effects, like acne, gum inflammation, increased viral
infections, cervical ectropion (which may increase the
risk of chlamydia),
contraceptives are least used in India, China and Japan.
However, with increasing urbanization and change in life
style, there is an increased demand for the pill in India
also. With newer molecules being marketed to avoid the side
effects produced by older preparations, it is necessary to
remain appraised of the side effects caused by “pill” as
well as the effects it may have on various medical
enumerate in short, the side effects caused by oral
contraceptive pils(OC’s) could be major or minor, and they
are listed in the table below.
may not accept OC as a method of contraception as they are
afraid of side effects, but seldom abandon the use of OC’s
due to side effects per se. Lacks of accessibility, failure
to take the drug regularly, etc are more common reasons for
discontinuation. The most common treatment-related adverse
effects are headache, nausea, breast tenderness, and weight
Found occasionally in a few patients, it is usually
not very bothersome. Low fat,low residue, spaced meals,
reduce functional nausea. In addition,
changing the OC to a high progesterone, low estrogen
combination could be tried. The symptoms of bloating or
swelling begins in the active week before the hormone-free
interval and is most prevalent during that time3.
Break through bleeding:
Breakthrough bleeding is greatest in the first 3 months and
it’s frequency decreases after that. Low dose
oestrogen pills containing 20 microgram of estrogen are more
likely to produce disorders in cycle control. It is even
more frequent in women taking COC 15-μg Ethinyle Estradiol
(EE) than in those using 20-μg EE. Pills containing
norethisterone produce more irregularities than those
If the woman could be reassured that
bleeding will not reduce contraceptive efficacy and that it
is only the result of the endometrium trying to adjust it’s
thickness to the new hormone levels, no treatment need be
given. However, if it is distressing, to continue to let
the woman enjoy the benefits of low dose oestrogen pills,
these women could beneficially be given 1.25mg conjugated
estrogen or 2 mg estradiol daily for 7 days when bleeding is
present. If 1 course of oestrogen is not enough, another 7
days of estrogen use is effective.
Amenorrhoea: Amenorroea is an
uncommon side effect found in some women, caused by
endometrial atrophy. It is distressing to some women, as it
may be a sign of unwanted pregnancy. Addition of extra
oestrogen for 1 month (1.25mg conjugated oestrogen or 2mg
estradiol) daily throughout the 21 days of that cycle will
rejuvenate the endometrium and withdrawal bleeding resumes,
persisting for many months. This could be resorted to in
patients who prefer not to remain amenorrhoeic.
Headache: Headache, specially,
migrainous headache is more prevalent in OC users.
Migrainous headaches frequently occur in the hormone free
period, when oestrogen levels are falling. Use of estrogen
replacement in this hormone free period could reduce this
symptom. However, women with migraine accompanied by aura
are best advised to avoid OC’s. Evidence from six
case-control studies suggested that COC users with a history
of migraine are four times as likely to have an ischemic
stroke as nonusers with a history of
Weight gain: Weight gain due to
water logging caused by progestin content was a common
complaint in the past. The current low-dose OC containing 20
μg ethinyl estradiol EE and 100 μg LevononorgestrelLNG did
not cause weight gain and was safe and well tolerated in a
double blinded placebo controlled trial. In another trial,
among users of two 20mcg oestrogen-containing pills, in a
one-year trial, 13% lost >2kg, 74% stayed at the same
weight+2 Kg, and 13% did gain >2kg. In fact, studies have
shown that women often begin taking the pill during a time
of life that typically coincides with weight changes, giving
the pill an undeserved reputation for adding weight.
Breast tenderness: Incidence of
this complaint is less with use of low dose estrogen pills.
In a study comparing 3 types of contraceptives, participants
in the Levonogestrel containing OC pill group experienced
nausea, breast tenderness and irritability more frequently
than did those in the other groups, using gestodene and
etonogestrel as progestins. Shortening the hormone-free
interval from 7 to 4 or 5 days might increase the
contraceptive safety margin and decrease the prevalence of
symptoms such as breast tenderness and headaches.
Major side effects:
Combined oral contraceptives are by and
large very safe. However, in the rare special cases, it may
cause serious side effects and awareness of these side
effects could prevent major complications in these special
Cardiovascular side effects:
A WHO study found no increased risk of
heart attack among healthy pill users.
Less than 5% of women using hormonal
contraception develop hypertension, which may increase their
risk for heart attack and stroke1. Blood
pressure checking should be an important part of clinical
evaluation of pill users.
Thrombotic events: Oral
contraceptives (OC) have been implicated in causing
increased blood coagulation. The hormone changes during
pill ingestion are akin to those occurring in pregnancy and
similarly, the risk of thrombotic events is also present
only in the rare individual prone to it. The risk posed is
actually less than that incurred by pregnancy. Women with
an inherited resistance to activated protein C, the factor V
Leiden mutation, congenital deficiencies in antithrombin
III, protein C, or protein S, are prone to thrombotic
Acute maculo-neuroretinopathy, macular
haemorrhage, central retinal vein occlusion, central retinal
artery occlusion, and perivasculitis have been reported,
mostly in patients on oral pills for a long time. Although
long term use is unlikely in India, a rare case of central
retinal artery occlusion following OC pills has been
reported from India after 4 months of use of Mala-D2.
The risk of development of
vein thrombosis was also found to be 2
to 5 times greater with a low-estrogen,
contraceptive than with
second-generation monophasic and triphasic
preparations(containing progestin of the norgestrel type).
Because desogestrel may have benefit for some patients,
specially women with excessive androgen activity, one may
restrict its use only for selected users prone to such
Risk of cancer: Oral
contraceptive use is associated with a very slight increase
in breast cancer risk (relative risk=1.2) for current users
vs. never-users. However, breast cancer risk associated
with the use of oral contraceptives disappears with time
when use is discontinued. 1-4 years after discontinuation
the relative risk is 1.16, at 5 to 9 years after use the
risk is 1.07, and by 10 years from last use, breast cancer
risk of ever-users is not different from never-users. It
has been found that even in women with familial cancer
syndrome, incidence of breast cancer is not higher among
oral contraceptive users compared to non-users.
There is an increased incidence of
cervical cancer in HPV positive women on prolonged use of
oral contraceptives (>5 years). Till HPV screening becomes
cheap and routine, yearly pap smear should be recommended
for all women on oral contraceptive pills.
Incidence of ovarian cancer is reduced
in OC users and incidence of colorectal cancer is reduced in
current users of OCs. There is no increased incidence of
hepatocellular cancer and effect on lung cancer is known
with use of OC’s.
Glucose intolerance: Increased
insulin resistance in pill users is generally met by
increasing insulin secretion, and there is just a slight
elevation of 1 hour glucose levels. Low dose pills may be
used by diabetic women. However, high, pharmacologic dose
of estrogen should be avoided by women with diabetes and
vascular disease or major cardiovascular risk factors.
Oral contraceptives and medical
Women who should avoid combined oral
- Women known to have stones or a
positive history for gallbladder disease
- Women with triglyceride levels
>20mgm/dl and women with existing vascular disease.
- Mitral valve
prolapse complicated with atrial fibrillation,
migraine headaches, or clotting factor abnormalities
- Women with
congenital heart disease or valvular heart disease
if there is marginal cardiac reserve or a condition that
predisposes to thrombosis.
- Smokers over 35 years of age
- Women with systemic lupus
Conditions where combined oral
contraceptives are safe:
- Women younger than 35 years who
have hypertension well controlled by medication and who
are otherwise healthy and do not smoke.
- Women with pregnancy induced
hypertension after the Blood pressure is normal
- Women with history of gestational
- Women with fibroids, if low dose
pills are used.
- Benign breast disease.
- Women with seizure disorders.
However, some antiepileptic drugs decrease efficacy of
the pill, and this should be kept in mind.
- Women with depression.
- Women with sickle cell trait.
- Women with hemorrhagic disorders
and women taking anticoagulants.
- Infectious mononucleosis provided
liver function tests are normal.
- Ulcerative colitis
- Regional enteritis (Crohn’s
- Elective surgery if prolonged
immobilization is not anticipated and if low dose
preparations are used. COC should be used till the last
day before sterilization operation is performed if the
woman is using it as a contraceptive measure.
- Women with varicose veins,
provided it is not very extensive.
The newer low oestrogen contraceptives
and the use of newer progestins accompanying it have reduced
side effects of combined oral contraceptives to a great
extent. Most of the studies which showed side-effects of
oral contraceptives were done on the earlier preparations
with high oestrogen content. However, while using oral
contraceptives for dysfunctional uterine bleeding, higher
oestrogen doses may have to be employed and in these
patients, the practitioner should be aware of all side
effects, to take effective steps.